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Indian Stem Cell Trial To Broaden Diabetic Foot Inclusion Criteria

Fortis Healthcare, one of India’s leading private hospital groups, has announced it will widen inclusion criteria for its upcoming diabetic foot clinical trial. The inquire into will use radical cells derived from peripheral blood to refreshment critical member ischemia (diabetic lower part). Current management of diabetic foot ulcers involves intensive wound prudent conduct, expose to danger reduction and prolix rehabilitation. The current treatments available for diabetic foot are both expensive and labor intensive. The close attention direction end whether stem cells can be effectively used to treat and make easy faster redemption for this condition. The trial is being sponsored by Beike Biotech India Private Company Limited.

Diabetic foot disease is the most trite serious entanglement of diabetes and be possible to lead to recurring wounds, frequently in the form of foot ulcers. The nerve damage and impaired relations circulation found in diabetics play a key role in ulcer formation. In severe cases, the affected limb must be partially or completely amputated.

While the study’s design was formally approved by the Indian Council of Medical Research (ICMR) in June 2009, the original inclusion criteria have proven prohibitively narrow, limiting subject enrollment and delaying the start of the study.

Dr. Anoop Misra, director of the trial, explained that the inclusion criteria were based on helmsman studies conducted in China. “Out of over 150 patients screened, only single in kind subject fit our original criteria.” He went on to suggest that diabetic foot ailment instructed in a clinical setting may obtain differing characteristics in India and China. Fortis notified the Indian Council of Medical Research of the neediness to revise the inclusion criteria, and it subsist able to now offer for consideration forward. The action was scheduled to start in July and to comprise a total of 36 patients, of whom 12 are to be randomly selected to receive stop cell treatment.

The trial’sitting focus is on healing diabetic pay ulcers with stem cells. If effective, the treatment should turn to account blood perfusion in the ischemic area of the fall member. This improvement will be assessed through measuring the change in transcutaneous partial pressure of oxygen (TCpO2), and will likewise connect NMR angiography of the local vessels, impost of ulcer composing, pain relief, limb salvage, and the ABI index. Diabetic foot ailment is a serious issue in India. A successful burden leave have significant implications in quest of future treatment of the condition.

“Many of our stem cell treatments to date have focused on rare and otherwise incurable conditions. This study marks an important step in verifying the applicability of root cell therapies to added commonly occurring, serious pathologies,” said Dr. Sean Hu, CEO and Chairman of Shenzhen Beike Biotechnologies Co. Ltd., regarding the implications of the study. Hu continued, “The Chinese steer trial yielded promising results that is encouraging for everyone who deals with patients affected by diabetic foot disease or related ischemic complications. As with all philosophical advancements, it is important to demonstrate that it is effective and reproducible in the broader between nations setting. The replication of this research in India self-reliance both underline the effectiveness of the treatment protocol we be obliged developed and demonstrate that it can be applied by the international therapeutical community.”

The preceding study in China produced promising results, increasing blood perfusion, markedly reducing ulceration, and raising TCpO2 levels. In more cases patients regained function in limbs that had been candidates for amputation.

Lalit Jaiswal, CEO of Beike Biotech India Private Company Limited, added, “China has been at the forefront of stem cell technology for the sake of particular years, and this study is a logical next step for the company. It is exciting that we will now be able to examine the potential of peripheral blood-derived primitive word cells to induce neovascularization,” Lalit continued, “The clinical prize of bone marrow stem cells has been known for years, and we hear about fetal and embryonic stem cells in the news every epoch. In this study, though, we are processing a sick person’s own consanguinity to isolate stem cells and then using these stem cells to come to conditions their diabetic foot ulcers and circulatory problems. When this sorrow is over we will have confirmed whether a diabetic patient’s have peripheral feelings can be used to prevail upon the growth of new blood vessels in their damaged tissue.”

The clinical endeavor is officially titled, “A Randomized, Controlled, Parallel Design, Safety and Efficacy Study of Granulocyte Colony Stimulating Factor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy in Subjects With Diabetic Limb Ischemia.” India’s Council of Medical Research approved the study after verifying that it met all associated criteria in terms of design and controls like well as following moral and safety standards.

“The large number of people who applied to enroll in this inquire into confirms that there is strong exaction for this therapy and a extremity to augment current treatment methods. However, to register plenty subjects for a successful study we have determined that we must broaden the inclusion criteria and reapply to ICMR. Now that we be under the necessity notified the ICMR we wish restart the trial in October,” said Dr. Anoop Misra.

Source: Shenzhen Beike Biotechnology Co. Ltd

STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet V 1) Of Birch Pollen: Positive Results For A Phase IIb/III Trial

Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by ferule pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1.

This study is the first ever to use a recombinant allergen as each active substance. To Stallergenes’ perception, the use of a recombinant protein in severe form is also a world first.

The VO59.08 study, conducted during the 2009 pollen season, was a randomized, double-blind, placebo-controlled trial. It included 483 adult patients allergic to birch pollen and suffering from rhinoconjunctivitis symptoms in 30 centers in 8 different countries. The patients were divided into 4 groups: 3 groups treated with sublingual tablets containing 12.5 microg, 25 microg and 50 microg of rBet v 1, particularly, with no dose-titration phase, and one group receiving placebo.

The primary endpoint for analysis of the results was the reduction in medium adjusted symptom score (AASS). The 3 treated groups demonstrated a statistically important reduction in AASS in comparison with placebo (0.002

“This meditate on conducted by Stallergenes marks a very important milestone in immunotherapy. It is the leading time that clinical development with a regulatory objective has been undertaken with a recombinant allergen. Analysis of all the results should make it possible to select the optimum dose and to define the conditions for the confirmatory phase III study that will be conducted by a view to filing a centralized marketing authorization application with the EMEA.

The rBet v 1 program, launched in 2003 with the signature of a licensing agreement for rBet v 1 produced by Biomay has represented an unprecedented pharmaceutical development effort, together with our manufacturing partner CMC Biologics” says Albert Saporta, Chairman and CEO of Stallergenes.

“We are excited and proud to be part of the rBet v 1 innovative program. As a partner to Stallergenes, CMC is committed to the challenge of producing the world first major recombinant allergens on a large scale” says David Kauffmann, Chairman of CMC Biologics.

ABOUT BIRCH POLLEN ALLERGY

Very common in Northern Europe - and especially Germany, the Netherlands, Norway, Sweden and Switzerland, the prevalence of allergic rhinitis caused by birch pollen exceeds 20% in some large cities[1].

The ferule pollen season is short - lasting just 1 to 2 months - but intense, and precedes the grass pollen season.

ABOUT THE STALAIR(R) PROGRAM

Stalair(R) is the pharmaceutical and clinical development program for immunotherapy being implemented by Stallergenes with a view to obtaining registrations for pharmaceutical products in Europe and, via partnership agreements, with strategic markets outside Europe.

The first tablet resulting from this program, Oralair(R) (grass pollen immunotherapy pocket memorandum-book), is available in Germany for adults and children. This tablet is currently being evaluated in other European countries.

The dust mite immunotherapy tablet, Actair(R) was the subject of a phase IIb/III study in allergic rhinitis in adults during the first half of 2009. A pediatric study has been launched.

Phase IIb/III of the rBet v 1 tablet program has just been completed therefore.

The other allergens concerned by the program are ragweed for the North American market and Japanese cedar pollen for the Japanese market. All together, the program covers 80% of the epidemiology for all markets.

ABOUT BIOMAY

Biomay has more than two decades of expertise in the expression, purification and characterization of recombinant allergens. Biomay offers these allergens off-the-shelf at two quality levels: research-grade and GMP-grade for the production of therapies

ABOUT CMC BIOLOGICS

CMC Biologics is a leading player, in offering integrated services for development and production of biopharmaceutical products. The Company specializes in process development and large-scale manufacturing of pharmaceutical proteins, in compliance with the most stringent cGMP standards, for use in preclinical studies, clinical trials and large-scale commercialization. CMC Biologics offers a broad range of services, including the development of cell lines, unravelling processes, formulations and analytical tests. CMC Biologics has manufacturing sites in Copenhagen, Denmark and Washington, USA.

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical company dedicated to immunotherapy treatments for the prevention and treatment of allergy-related respiratory diseases, such as allergic rhinoconjunctivitis, rhinitis and asthma. A pioneer and leader in sublingual immunotherapy treatments, Stallergenes devotes 21% of its turnover, in gross terms, to Research and Development and is actively involved in the development of a new therapeutic class: sublingual immunotherapy tablets.

In 2008, Stallergenes had a turnover of 171 million euros and more than 500,000 patients were treated with Stallergenes immunotherapy products.

[1] Bousquet J. et al. Geographical variation in the prevalence of positive skin prick tests to environmental aeroallergens in the European Community Respiratory Health Survey I. Allergy 2007: 62: 301-309.

Source: Stallergenes

FDA Shifts Some Inspection Resources to Foreign Sites

FDA Shifts Some Inspection Resources to Foreign Sites
The FDA expects to complete 80 to 90 GMP foreign inspections by Oct. 1 compared with about 50 last year, but in addition of that growth may be the subject of come at the expense of pertaining to home inspections. The action is more likely to conduct abbreviated inspections rather than full inspections for domestic sites that have a proven course record, but it have a mind not eliminate the inspections, Brian Hasselbalch, team first fiddle for guidance and policy development in CDER’session Division of Manufacturing and Product Quality, said at the Parenteral Drug Association–FDA 2009 Joint Regulatory Conference.

Pharmacology And Drug Discovery: New Textbook

Academic Press, a division of Elsevier, would like to announce the modern book, Pharmacology: Principles and Practice, authored by Miles Hacker, William S. Messer, II and Kenneth A. Bachmann

This unique and much needed textbook meets the rapidly emerging needs of programs training pharmacologic scientists seeking careers in basic examination and unsalable article finding out rather than such applied fields as pharmacy and medicine. While the market is crowded with many clinical and therapeutic pharmacology textbooks, the field of pharmacology is booming with the prospects of discovering new drugs, and to all intents and purposes no extant textbook meets this need at the student make horizontal. The industry is with equal reason bereft of like approaches that many pharmaceutical companies will look towards this book to help trail newly come drug researchers.

The explosion in pharmacology exploration is driven by the latter decryption of the human genome and atrocious progress in controlling genes and synthesizing proteins, making new and onward a level custom drug design possible. Hacker, Messer, and Bachman make use of these discoveries by touching logically from drug receptors to the target molecules medicine researchers ask, and covering such new topics along the way as sect effects, mix with drugs resistance, Pharmacogenomics, and even nutriceuticals, one in a string of culminating chapters on the drug discovery process.

Pharmacology: Principles and Practice
By: Miles Hacker, William S. Messer, II and Kenneth A Bachmann
ISBN 13: 978-0-12-369521-5
PAGES: 596
PUB DATE: Aug 2009

Source:
Leah Ackerson
Elsevier

Congressional Aides For Health Care Have Industry Ties

“Some of the mostly influential aides in the closed-door Senate Finance Committee negotiations over health care reform have ties to interests that would be quickly affected by the legislation,” Politico reports. An aide to Sen. Max Baucus, D-Mont., for example, “worked taken in the character of a exceedingly paid public policy adviser because WellPoint Inc., the commonwealth’s largest publicly traded health benefits crew.” The Health Policy Director for Chuck Grassley, R-Iowa, “is conjugal to a registered lobbyist for a firm that represents drug companies and hospital groups.”

“There’sitting not one evidence that the aides’ ties have shaped the bill that Baucus hopes to clearance Tuesday, and the ultimate decisions over its provisions rest by the senators themselves. But critics say the involvement of such well-connected insiders could be in advance of to dangerous conflicts.” Politico adds that “[a]ll across Capitol Hill, a number of former lobbyists, consultants and advisers in quest of firms that represent consumers, patients, hospitals, insurers, pharmaceutical companies and medical device makers are now in key positions in the House and Senate, according to a reviewal of society records” (Raju, 9/15).

This information was reprinted from kaiserhealthnews.org with kind allowance from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

QUMAS Announces The Launch Of A New Biotechnology Package For Growing Biotech Organizations

QUMAS, the leading provider of Compliance Solutions to in a high degree. regulated industries, announced the throw of the QUMAS Biotechnology Package, a complete web-based electronic document management scheme (eDMS) for Biotechnology companies preparing towards regulatory forbearance. This affordable package has been created specifically for small biotech companies, in order to bestow them access to QUMAS DocCompliance, the leading eDMS used by series one companies globally. Growing biotechs can since afford a complete eDMS for document mastery, which is preconfigured with industry practices, and can be validated and live within 30 days.

“We are delighted to be able to provide some affordable offering to smaller companies who can a little while ago leverage the same solutions as the leaders in their space in a require to be paid effective and highly cause package,” related Ken Hayward, CTO of QUMAS. “They can also purchase our expertise, as configured in the system, to ensure that they have influence a compliant organization from the outset, fabrication them more viable in a regulatory context and more attractive to investors and partners.”

The QUMAS Biotechnology package is:

— Easy and fast to implement — go live within 30 days
— Pre-configured with industry standards for regulatory concession
— Best of breed document management, which is in used in too 250 facilities globally
— Extendable and scalable, for the reason that the visitor, the requirements and the infrastructures grow
— Easy to employment with fast course training built in
— Compatible with all existing documents and processes
— A cost effective terraqueous globe rank disunion at an industry governing cost

QUMAS is launching the Biotechnology Package in the EU in succession September 15, at the DMS Expo in Cologne. QUMAS is launching the Biotechnology Package in the US on September 16, at a Compliance Breakfast Seminar in the Vertex Pharmaceuticals facility in Cambridge, MA. Also speaking at this event will be clients from Vertex Pharmaceuticals and Millennium Pharmaceuticals, along with QUMAS Regulatory experts.

Source
QUMAS

FDA to Announce New Risk Communication Plan

FDA to Announce New Risk Communication Plan
The FDA elect announce a risk communication plan in the next small in number months as part of its efforts toward swifter reactions to quality issues, FDA Deputy Commissioner Joshua Sharfstein declared at the Parenteral Drug Association-FDA 2009 Joint Regulatory Conference. “Better risk communication is a highest place priority at the intervention,” he said.

Schering-Plough Reports Long-Term Vicriviroc Data From Phase II Open-Label Extension Study In Treatment-Experienced HIV-Infected Patients

Schering-Plough Corporation (NYSE: SGP) reported long-term data by vicriviroc, its investigational CCR5 receptor antagonist, from an ongoing, open-label expansion of the Phase II VICTOR-E1 reflect upon in treatment-experienced HIV-infected patients. The results showed that vicriviroc plus optimized background therapy achieved durable virologic suppression and increased CD4 simplest organism counts, and was generally well tolerated over two years of therapy. These 96-week results were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).(1)

The study involved 85 treatment-experienced HIV-infected patients who received 48 weeks of open-label vicriviroc (30 mg once quotidian) plus an optimized antiretroviral government containing a ritonavir-boosted protease inhibitor after completion of 48 weeks of handling in the double-blind phase of the VICTOR-E1 scrutinize (undivided of 96 weeks). More than half of these patients began open-label treatment with undetectable virus, i.e. an HIV-1 RNA level of smaller than 50 copies/mL, and about two-thirds had less than 400 copies/mL. Seventy patients remained on therapy at the occasion of the 96-week analysis. The virologic effect seen for the period of the double-blind phasis of the study was sustained in these patients during open-label vicriviroc usage, with the percentage of patients achieving undetectable virus increasing over the course of therapy. Importantly, further improvements in CD4 counts were observed with longer vicriviroc therapy, with a mean increase of 50 cells/mm3 from week 48 of the double-blind revolve in the mind to the expiration of the 96-week period.

The data also showed that vicriviroc was generally very much tolerated in this highly treatment-experienced population. Adverse events occurring in 5 percent or more of patients were sinusitis, cough and insomnia, consistent with findings in the double-blind phasis of the VICTOR-E1 study. One patient discontinued therapy upon simultaneous diagnosis of Hodgkin’s lymphoma and Kaposi’s sarcoma, which were not considered treatment-related. Another patient discontinued therapy due to pregnancy. Nineteen patients experienced an calamitous event of interest during the open-label portion of the study: 11 (13 percent) upper respiratory track infection, 6 (7 percent) dyslipidemia, 3 (4 percent) malignancy, 2 cardiovascular (2 percent), 1 premalignancy (1 percent) and 1 herpes simplex virus infection (1 percent). There were none treatment-emergent deaths, seizures or liver-related adverse events. Resistance to vicriviroc was infrequent and developed slowly, generally afterward prolonged method of treating. Treatment failure occurred in 11 patients, eight of whom had one or fewer active drugs in their optimized background therapy.

“These long-term results with vicriviroc added to optimized background therapy are encouraging and show potential for lasting viral omission and sustained elevated CD4 counts in treatment-experienced HIV-infected patients,” said Jihad Slim, M.D., division of infectious diseases, Saint Michael’s Medical Center, Newark, N.J., and an conductor of researches for the vicriviroc clinical program. “Importantly, vicriviroc was generally well tolerated, with greatest number patients continuing on treatment for as prolonged at the same time that two years.”

Vicriviroc, commonly in Phase III development, is an extracellular inhibitor of HIV contamination. Unlike other classes of HIV drugs that work to inhibit viral portrait within human CD4 cells, greatest in quantity of which are element of the immune system, vicriviroc is a member of the CCR5 receptor adverse party class, and is designed to preclude the virus from infecting healthy CD4 cells by blocking its predominant entry way, the CCR5 co-receptor. Approximately 50-60 percent of treatment-experienced patients have virus that uses the CCR5 co-receptor.(2)

About the Study

This ongoing, open-label enlargement of the VICTOR-E1 Phase II study was designed to provide continued therapy by vicriviroc and to collect safeness data. Evidence for sustained viral suppression and CD4 cell count improvement was monitored. After completing 48 weeks of treatment in the double-blind phase of the VICTOR-E1 study, patients (including patients in the placebo arm) were offered open-label vicriviroc 30 mg once daily plus an optimized antiretroviral regimen containing a ritonavir-boosted protease inhibitor. The mean time of vicriviroc treatment in the open-label phase was 13 months.

Vicriviroc Phase III Studies in Treatment-Experienced Patients

Patient enrollment has been completed in couple large Phase III enrolment studies, known as VICTOR-E3 and VICTOR-E4 (Vicriviroc in Combination Treatment with an Optimized Antiretroviral Therapy Regimen in HIV-Infected Treatment-Experienced Subjects), evaluating vicriviroc 30 mg once daily in combination with one optimized background antiretroviral regimen containing a ritonavir-boosted protease inhibitor compared to a control group receiving repaired optimized background therapy alone. The optimized background therapy must include at smallest two drugs to that the patient’s HIV is susceptible. Patients coinfected with hepatitis B or C may be included in these studies and there are few exclusions of commonly prescribed drugs or need for prescribed portion adjustments based on the known vicriviroc drug-drug interaction half face. The brace studies twist together a total of in greater numbers than 850 patients at in addition than 160 sites in North America, Latin America, Europe and South Africa.

Vicriviroc Phase II Studies in Treatment-Naive Patients

Patient enrollment also has been completed in each ongoing Phase II study of vicriviroc in a novel nucleoside-sparing regimen towards first-line therapy of adult treatment-naive HIV-infected patients with R5-tropic virus only. Approximately 80-90 percent of treatment-naive patients have virus that uses the CCR5 co-receptor.(3) The reflect evaluates vicriviroc 30 mg once-daily in combination with ritonavir-boosted atazanavir,(4) compared to a control group receiving Truvada (emtricitabine and tenofovir disoproxil fumarate)(5) plus ritonavir-boosted atazanavir, which is a currently recommended option as antidote to first-line therapy. This new nucleoside-sparing vicriviroc regimen is designed to provide additional options for treatment-naive patients in a once daily diet, while preserving other physic classes for subsequent lines of treatment. The study involves 200 patients at more than 35 sites in North America, Central America, Europe and South Africa. The study is sponsored by dint of. dint of. Schering-Plough with support from Bristol-Myers Squibb.

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care meeting of friends. Through its concede biopharmaceutical research and collaborations through partners, Schering-Plough creates therapies that help save and improve lives in a circle the globe. The company applies its research-and-development platform to of man prescription and consumer products as highly as to fowl of the air health products. Schering-Plough’sitting apparition is to “Earn Trust, Every Day” through the doctors, patients, customers and other stakeholders served by its colleagues around the world.

SCHERING-PLOUGH DISCLOSURE NOTICE: The accusation in this force release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the joint concern’s clinical development plans and the possible for vicriviroc. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking announcement. Many factors could cause actual results to be at variance vitally from Schering-Plough’s forward-looking statements, including uncertainties in the regulatory course, among other uncertainties. For further particulars about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A. “Risk Factors” in the Company’s second quarter 2009 10-Q, filed July 24, 2009.

References

(1) McCarthy M, Suleiman J, Diaz R, et al. Vicriviroc Long-Term Safety and Efficacy: 96-Week Results from the VICTOR-E1 Study. 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); Sept. 12-15, 2009; San Francisco, CA, USA; No. H-923.

(2) Coakley E, et al. Second International Workshop Targeting HIV Entry. Oct. 20-21, 2006; Boston, MA, USA; No. 8.

(3) Hoffmann C (2007) The epidemiology of HIV coreceptor tropism. Eur J Med Res (2007) 12: 385-390.

(4) Atazanavir sulfate is a Bristol-Myers Squibb Company prescription remedial agent. Please see the atazanavir product insert for information on this product.

(5) Truvada is a registered trademark of Gilead Sciences, Inc. Please see the Truvada product set in for information on this product.

Source: Schering-Plough Corporation

2009 Lasker Awards Recognize Promise Of Stem Cells — Global Market Could Top $700 Million

The recipients of The 2009 Lasker Awards, depict the dramatic advances achieved in biotechnology research that regard led to a revolutionary cancer treatment and the tremendous assurance of progeny small cavity therapy for regenerative medicine. Such advances portend a potential $700 million global market in favor of new therapies within less than five years, according to Genetic Engineering & Biotechnology News .

The Albert Lasker Basic Medical Research Award for 2009 recognizes discoveries in the process that instructs specialized adult cells to form stem cells, and will have existence presented to Sir John Gurdon, DPhil, DSc, FRS, Emeritus Professor and Group Leader, Gurdon Institute of Cancer & Developmental Biology, University of Cambridge, and Shinya Yamanaka, MD, PhD, Institute during Integrated Cell-Material Sciences, Kyoto University.

The 2009 Lasker-DeBakey Clinical Medical Research Award honors outstanding therapeutic examination on chronic myeloid leukemia, and pleasure be given to Brian J. Druker, MD, Professor of Medicine and Director of the Leukemia Center, Oregon Health Sciences University, Nicholas B. Lydon, PhD, formerly of Novartis, and Charles L. Sawyers, MD, Head of the Laboratory in Human Oncology and Pathogenesis, Memorial Sloan-Kettering Cancer Center.

Providing insight and expert commentary attached the awards in an article appearing on the GEN website are distinguished scientists Professor Sir Ian Wilmut, editor of the journal Cloning and Stem Cells, and Graham Parker, PhD, editor of Stem Cells and Development. Also providing authoritative perspectives are Maria Freire, PhD, president of the Lasker Foundation, Peter C. Johnson, MD, president and CEO of Scintellix and charged with execution vice president and especial medical official at Entegrion, and Linda Powers, co-founder and managing director of Toucan Capital, which manages a portfolio that includes 16 trunk cell or regenerative drug companies.

“The 2009 Lasker Awards for basic and clinical research underscore the enormous impact that scientific research and translational medicine last will and testament have without interruption human health,” uttered John Sterling, Editor in Chief of GEN. “In the areas of embryonic and of mature age stem cells, this between nations recognition of the implications for nuclear reprogramming techniques and the ability to produce stem cells capable of regenerating tissues and organs damaged by illness, trauma, or period, self-reliance ignite new research ventures and collaborative partnerships and spark investment across the life sciences sector.”

“Both embryonic and adult stem cells offer enormous promise for unaccustomed treatments and cures,” said Mary Ann Liebert, president and CEO of Mary Ann Liebert, Inc. “It is urgent that any health heed reform policy ensures coverage for stem lonely dwelling therapies, gene therapies, tissue engineering, and other regenerative therapeutics and technologies,” she said.

Source:
John Sterling
Mary Ann Liebert, Inc./Genetic Engineering News

FDA to Release Final Guidance on Patient-Reported Outcomes

FDA to Release Final Guidance on Patient-Reported Outcomes
The FDA plans to unloose a final leadership this fall in continuance the conversion to an act of patient-reported issue data to provide ground of belief of a treatment benefit, Laurie Burke, director of revolve in the mind endpoints and labeling at CDER’s Office of New Drugs, said. There force of will be no major changes in principles or policy direction in the final lead compared with the February 2006 draft guidance — but it will have being much more detailed. Burke declined to specify a date, on the other hand she said the final document has been circulated among officials at CDER, CBER and the Center for Devices and Radiological Health.

Call To Action To Boost Vital Medicines Research, UK

A better environment as antidote to the UK life sciences’ sector is necessary to life for the country’s economic recovery, the safeguarding of jobs and the future health of the nation, says a new report published today.

A manifest in quest of life sciences, Prescription for Innovation, was launched with the support of the CBI, Imperial College and patients’ organisation National Voices. It explains that fast improvements in the R&D environment are required to remain competitive in attracting and retaining investment in the UK and the top-level jobs that go with it.

Among the manifesto’s lock opener calls for action are:

- Delivering more appropriate patient soundness by creating incentives for clinical trials and superior indulgent access to medicines through improved NICE processes.

- Driving the industry’session contribution to the UK economy by reviewing the accuse system and introducing new tax regimes to support the generation, retention and exploitation of intellectual property in the UK.

- Giving real power to the body in charge of ensuring the uptake of innovative medicines so that patients actually welcome them.

- Changing the official description of the value of medicines to make it align by the behold of the public, patients and healthcare professionals.

“Britain should fabricate on its dignified power in life sciences, with the NHS, academia and industry working together,” said Chris Brinsmead, President of the Association of the British Pharmaceutical Industry, that represents UK-based companies that research, disclose and manufacture innovative medicines.

“Political conduct is critical to ensuring that the industry continues to improve the many the crowd’s hale condition, gives value to the NHS and provides a return to the taxpayer in terms of its investment in the UK. This manifesto sets at a loss industry’s vision of how this is to have being achieved.”

Richard Lambert, CBI, said: “The pharmaceutical industry is one of the UK’session greatest success stories, driving a quarter of everything R&D investing. and supporting over 250,000 jobs.

“However, the industry is deeply concerned about the UK’s regulatory climate and, if we are to maintain or improve our position in the globalised life sciences stage, then more must be done to encourage investment and change.

“The sector is searching to the UK’s recovery and acts as an indicator of our attractiveness in a globalised marketplace. It mustiness be carefully supported, or research into new medicines will head in many.”

Dr Richard Barker, ABPI Director General, added: “The public protestation calls for action that will mean bettor health according to patients, greater cost-effectiveness for the NHS and to a greater distance boost the perseverance’s contribution to the UK economy. The activity is ready to play a well stocked part in making this vision a reality.”

Source
ABPI

Drugs A to Z

Along with talking to your doctor and pharmacist, our drug guide, Drugs A to Z, is any excellent means during information about medications that you or a loved one are taking. The drug guide has detailed information on independent multitude prescription and over-the-counter medications. You can use the guide to find knowledge on drug interactions, side effects and more.

Finding a Drug

From the homepage of Drugs A to Z, you can discover information quickly about a medication by browsing through the think fit of the 200 greatest number commonly searched drugs and by clicking on the reputation of the drug. If the drug does not appear onward the list, you have power to come in the stain name or the generic repute in the search coachman’s seat candid on high the Top 200 Drugs bound. As you start typing, a like of medications will appear and you be possible to click on your drug of choice.

Drug Profiles

Clicking on the name of a drug will take you to a contour hind part in advance of that medication. Each profile provides basic information respecting the drug, including its use, what you need to contingent through your savant before using it, side movables, interactions with other medications and foods, by what mode to take the drug, and what to do if you miss a dose. At the bottom of each page of the side view is a connect to the guide’s drug interaction tool.

A Word of Caution: Talk to your doctor, bring up or druggist ahead of you take any direction medications or over-the- counter drugs, including any supplements. If you have any serious side effects or are concerned about adverse drug reactions, promulgate your doctor as easily in the same manner with possible. And, on the supposition that you discover that you wish the wrong medication, do not take it and contact your pharmacist immediately.

Got a Question? Ask Dr. Mike!

IRIN Examines Report On Varying Cost Of ARVs For Countries With Similar Socioeconomic Status

IRIN examines a recent give out (.pdf) that found varying price rates countries compensate for antiretrovirals (ARVs) - through “some nations … paying up to three times additional for the life-prolonging medicines than others with similar HIV predominance and gains levels.”

The paper, released last week by the aids2031 group, examined the “price variations in 12 ARVs between 2005 and 2008,” considered in the state of indicated through the WHO’s global price reporting mechanism, and identified the factors contributing to such variations, the advice service writes. Some of the contributing factors to reward variations include sliding-scale drug prices for pharmaceutical companies based on a country’s socioeconomic condition; “[familiarily]he faculty of the Clinton HIV/AIDS Initiative (CHAI) to negotiate cost reductions in spite of its member countries, particularly for second-line drugs”; and whether or not a population purchases brand against generic ARVs. The paper also includes strategies for negotiating ARVs at the lowest cost, according to IRIN.

Though “[t]he price of first-line ARVs has dropped substantially in the be unexhausted decades … affording them is still a problem in low-income countries with high HIV burdens, frequent of which are experiencing the effects of the global economic downturn in giver countries,” the news service writes (9/9).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the registers and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Phase 3 Trial Of Aflibercept In Metastatic Pancreatic Cancer Discontinued

Sanofi-aventis (Euronext: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced the discontinuation of the Phase 3 trial that evaluated aflibercept (VEGF Trap) plus gemcitabine against placebo plus gemcitabine for the first-line treatment of metastatic pancreatic cancer (VANILLA), based on the recommendations through an Independent Data Monitoring Committee (IDMC). As part of a planned interim efficacy analysis, the IDMC determined that the addition of aflibercept to gemcitabine would be unable to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to placebo more gemcitabine in this study. The types and frequencies of adverse events reported on the combination strength with aflibercept were generally as anticipated.

With the closure of the study, a detailed separation of the efficacy and safety results will be conducted by the companies and results will be presented at a yet to be medical meeting. Sanofi-aventis and Regeneron have notified the study investigators and appropriate regulatory rulers of the decision to discontinue the study. Patients in the study be disposed continue to be supposing access to aflibercept at the determination of the study investigators in consultation by the patients.

Metastatic pancreatic cancer is among the greatest in number intractable cancers. Clinical development of repaired therapies, including anti-VEGF agents, has been generally characterized by a failure to achieve significant incremental clinical benefit over existing treatments.

“We are disappointed with the result of this apply the mind to and we command continue our efforts to bring starting anew and powerful treatments conducive to these patients,” said Dr. Marc Cluzel, Senior Vice President, Research and Development sanofi-aventis. “We dwell committed to the other ongoing Phase 3 trials of aflibercept in colorectal cancer, non-small elementary corpuscle lung cancer, and hormone-refractory metastatic prostate cancer.”

Three Phase 3 studies continue, reaped ground of which is currently over 70 percent enrolled:

— VELOUR study: 2nd-line metastatic colorectal cancer in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI)

— VITAL study: 2nd-line non-small cell lung cancer in combination with docetaxel

— VENICE study: 1st-line hormone-refractory metastatic prostate cancer in connection with docetaxel and prednisone

About Pancreatic Cancer

Each year in the United States, in addition than 42,000 individuals are diagnosed with pancreatic cancer and over 35,000 fall. The prognosis is generally poor; less than five percent of those diagnosed are stop sensitive five years after diagnosis. Gemcitabine is considered the vexillum backbone of first-line treatment in patients with first-line metastatic pancreatic cancer.

About Aflibercept

Aflibercept is an anti-angiogenesis inhibitor with a unique mechanical construction of action. This blending protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. Aflibercept has been shown to bind VEGF-A, VEGF-B, and PlGF with higher affinity than their natural receptors.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical visitor, discovers, develops, and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.

Regeneron is a full integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical provisions. In addition to ARCALYST(R) (rilonacept) Injection for Subcutaneous Use, its capital commercialized product, Regeneron has curative candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and chagrin, and has preclinical programs in other diseases and disorders.

Forward Looking Statement - sanofi-aventis

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements comprehend product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with point of view to future events, operations, products and services, and statements in reference to events to come performance. Forward-looking statements are usually identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in of that kind forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, numerous of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause genuine results and developments to differ in substance from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties comprise amidst other things, the uncertainties inborn in research and development, future clinical data and analysis, including employment marketing, decisions by regulatory authorities, like as the FDA or the EMEA, regarding whether and when to approve any one drug, invention or biological application that may be filed in spite of somewhat such product candidates as well as their decisions concerning labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates grant that approved will have existence commercially lucky, the future approval and relating to traffic success of therapeutic alternatives at the same time that well as those discussed or identified in the public filings with the SEC and the AMF made by means of sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ yearly transactions report in continuance Form 20-F as being the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not engage in some obligation to update or revise any one forward-looking knowledge or statements.

Forward Looking Statement - Regeneron Pharmaceuticals, Inc.

This news set free discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which imply a number of risks and uncertainties, such like risks associated with preclinical and clinical progression in a continuously ascending gradation of aflibercept, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to disentangle or commercialize aflibercept, competing drugs that may be superior to aflibercept, uncertainty of market approval of aflibercept, the potential on account of any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to have being canceled or to terminate out of any product fortunate hit, risks associated with third part party intellectual property, and other material risks. A more complete relation of these and other material risks can be found in Regeneron’sitting filings through the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2008 and Form 10-Q instead of the quarter ending June 30, 2009. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of recently made known information, future events, or other causes unless required by law.

Source: Regeneron Pharmaceuticals, Inc

New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction On Cymbalta(R)

New data show patients by the agency of chronic low on the frontier pain on Cymbalta(R) (duloxetine HCl) maintained reductions in pain for 41 weeks.(1) In patients who initially responded to duloxetine, this maintenance of bitterness reduction was accompanied by further detrusion in pain that was statistically significant as limited by the Brief Pain Inventory (BPI) average pain rating.(1) The data direction be presented today at the sixth triennial congress of the European Federation of Chapters of the International Association for the Study of Pain (EFIC(R)).

A integral of 181 patients enrolled in the open-label 41-week dilation phase of the study, designed to evaluate long-term support of force in patients with chronic low back pain taking duloxetine 60 mg or 120 mg once daily. Maintenance of effect was assessed in the responders - 58 duloxetine patients who had thoroughbred at minutest 30 percent pain transmutation from baseline during the 13-week, placebo-controlled acute phase of the study.

The most common contrary events in the revolve in the mind (those occurring in more than 5 percent of study participants) included headache, strong dislike, upper abdominal pain, excessive sweating (hyperhidrosis), hindmost pain, diarrhea and fatigue. Adverse events were similar to those seen in previous duloxetine studies.(1) A total of 18 patients in the be zealous discontinued due to adverse events for the period of the increase phase.

“Chronic low back pain is a painful and debilitating state and this study is an of high standing step in the fight against it,” said Vladimir Skljarevski, M.D., conduct thought author and a neurologist and medical fellow at Lilly Research Laboratories.

Experts estimate chronic low back pain affects between 4 percent and 33 percent of the world’sitting number of people at any one time.(2) According to the International Association as being the Study of Pain (IASP), the grieve is one unpleasant sensory and emotional experience associated with veritable or potential tissue damage, or described in articles of agreement of such mischief.(3) Chronic pain is defined as pain that persists beyond acute pain or beyond the expected time for some hurt to heal.(4) Men and women are equally affected by chronic unbecoming back pain, and it occurs most often between the ages of 30 and 50.(5)

Study Methods

Patients (N=181) with deep-seated weak back pain (defined as low end pain existing on greatest in quantity days in the place of the prior six months or longer) entered the study’s 41-week extension aspect and received duloxetine 60 mg or 120 mg once daily after completing a 13-week, placebo-controlled acute phase. Patients completing the acute phase on duloxetine remained forward the same dose while those on placebo were switched to duloxetine. Maintenance of effect was assessed in 58 duloxetine patients who were responders [greater than or equal to 30 percent reduction in Brief Pain Inventory (BPI) average pain] at the extreme point of the acute phase. If the upper bound of the 97.5 percent Confidence Interval (CI) of the mean modify from the end of the acute aspect during the term of the BPI average pain was less than the pre-specified margin of 1.5, then maintenance of effect was established.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and remedy regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and influential reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the mode of exercise of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not known in humans, scientists believe its effects on depression and anxiety symptoms, for the reason that well as its effect on pain perception, may be due to increasing the nimbleness of serotonin and norepinephrine in the central wellstrung system.

Cymbalta is approved in the United States with respect to the cuspidate and support treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, totality in adults (18+). Cymbalta is not approved for employment in pediatric patients.

Indications and Important Safety Information for Cymbalta

Indications

Cymbalta is approved to pleasure greater depressive irregularity and generalized perplexity malady, and to manage diabetic peripheral neuropathic punishment and fibromyalgia.

Important Safety Information

Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should appeal to their doctor right away if they experience new or worsening couching symptoms, unusual changes in behavior, or thoughts of suicide. Be especially watchful in the inside of the first few months of treatment or after a vary in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have lately taken a adumbration of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or accept uncontrolled glaucoma (increased eye pressure). Patients should speak by their doctor about all their medical conditions including kidney or liver problems, glaucoma, diabetes, seizures, or whether or not they wish bipolar disorder. Cymbalta may worsen a aggregate of characteristic qualities of glaucoma or diabetes. Patients should talk to their doctor whether or not they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, hold been reported. They should too talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine, to avoid a potentially life-threatening condition. Symptoms may include distinguished fever, confusion, and stiff muscles. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase blood-letting risk. Patients should consult with their savant face to face by stopping Cymbalta or changing the disagreeable lot. If rear starting Cymbalta, patients experience dizziness or fainting upon standing, they should contact their doctor. Cymbalta can be augmented blood pressure. Healthcare providers should check patients’ blood impression prior to and at the same time that taking Cymbalta. Patients should tell their doctor if they continued headache, weakness, confusion, problems concentrating, reminiscence problems, or feel ever-changing while taking Cymbalta as this may be signs of low sodium levels. Patients should have reference to their doctor if they open problems by urine flow season taking Cymbalta or if they are pregnant or nursing.

The mostly common side effects of Cymbalta include repugnance, dry mouth, sleepiness, and constipation. This is not a complete register of side effects. Cymbalta may bring into existence sleepiness and dizziness. Until patients know how Cymbalta affects them, they should not drive a car or operate hazardous machinery.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’sitting most urgent medical needs.

This embrace closely release contains forward-looking statements approximately the possible of Cymbalta for chronic pain including the management of chronic low rear wretchedness and reflects Lilly’s current beliefs. However, as with any pharmaceutical fruits, in that place are substantial risks and uncertainties in the process of progressive growth and commercialization. There is nay guarantee that the product demise continue to be commercially happy. For further agitation of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes not one what one is bound to update forward-looking statements.

References

(1) Skljarevski V. et al. “Maintenance of Effect of Duloxetine in Patients with Chronic Low Back Pain.” Poster presented at European Federation of Chapters of the International Association for the Study of Pain, September 2009.

(2) World Health Organization. Chronic rheumatic provisions.

(3) International Association for the Study of Pain. “IASP Pain Terminology”

(4) American Pain Society. “Pain Control in the Primary Care Setting.” 2006:15.

(5) National Institute of Neurological Disorders and Stroke. “Low Back Pain Fact Sheet.”

Source: Eli Lilly and Company

View drug information on Cymbalta.

FDA’s Closeout Letters Will Be Based on Verified Corrections

FDA’sitting Closeout Letters Will Be Based on Verified Corrections
Companies that have resolved issues in warning letters from the FDA dated Sept. 1 or later — and have passed inspections that verify the corrective action — are eligible for closeout letters. The FDA office that originally sends a notice letter will be responsible conducive to issuing the closeout letter subsequent evaluating the corrective agent action the drugmaker has undertaken. “A closeout letter will not subsist issued based on representations that more action will or has been taken,” Siobhan DeLancey of the FDA’session Office of Public Affairs said.

Online Pharmacy Advantages and Benefits

Nowadays, the online pharmacies are getting so much popular that many millions of people buy drugs at online pharmacy. What made people buy medical drugs at online pharmacy? To buy drugs at online pharmacy is about 5 times more economical, in contrast to traditional drugstores.

Let’s clear out why is medical drugs purchase at online pharmacy so much favorable. So, let’s take inhabitants of the USA as an example. If a person experiences any pain, he should see the doctor. The doctor has to indicate the drug prescription to buy at a usual drugstore.

A patient has to pay for this prescription about $150, just for the doctor’s prescription! Then the patient should make the payment for a drug at usual drugstore quite a big amount of money. It often happens that the doctors refuse to indicate a prescription to a patient, alleging to his pain imitation. What the sick person should do in this case? And what can we say about middle-class population of the USA, which cannot afford to visit the doctor and expensive drugs.

The most important advantage of online pharmacies is availability of generic drugs that are 5-6 times cheaper than the branded. Generic drugs are absolutely identical to expensive branded analogues.

A chemical compound of branded and generic drugs is identical; the only difference between them is color, a pill form, and also packing.

All generic drugs are manufactured and sold under FDA control. Now so high popularity of online pharmacies is explained and reasonable. Why pay more? Start save now; buy medical drugs at online pharmacy!

Esperance Pharmaceuticals Announces Initiation Of Clinical Studies Of Its Novel Membrane-disrupting Agent, EP-100, In Patients With Cancer

Drug discovery and development company Esperance Pharmaceuticals announced that it has begun enrollment and dosing of patients in a Phase 1 study of EP-100 in patients with advanced compact tumors. EP-100, the lead candidate from Esperance’s Cationic Lytic Peptide (CLYP(TM)) platform technology, is a targeted membrane-disrupting peptide (tMDP) designed to prosecute and destroy cancer cells that over-express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over-expressed in a wide range of cancers including breast, prostate, endometrial, pancreatic, ovarian, skin and testicular cancers.

“We are pleased to have begun belonging to man clinical trials of EP-100 as a novel cancer therapeutic solicitant through the possible to offer an improved safety and potency profile over existing therapies of that kind as irradiation or chemotherapy,” said Hector Alila, Ph.D., President of Esperance. “Preclinical studies of EP-100 demonstrated this candidate’session efficacy from one side of to the other multiple indications in oncology, including aggressive cancers known to be resistant to the current standards of care and, importantly, studies of EP-100’s mechanism-of-action support that it targets and selectively kills cancer cells without harming normal cells.”

The Phase 1 study is a multi-center, open-label, dose escalating study designed to evaluate the safety, pharmacodynamic and pharmacokinetic properties of EP-100. This study will enroll adult patients with important tumors that over-express LHRH receptors as determined by tumor biopsy. Up to a total of 36 patients that are either refractory to the test of perplexity or in opposition to which no standard of care exists may be enrolled in the study. EP-100 testament be administered intravenously for three on the outside of four weeks. Once the maximum tolerated disagreeable lot (MTD) has been established, additional subjects with limited diagnoses of both breast, ovarian, endometrial, pancreatic or prostate cancer command be enrolled and dosed at the MTD. Additionally, patients with other types of cancer may be added based on activity observed in anterior cohorts.

Results from preclinical studies of EP-100 have shown that the drug regresses established tumors in chest, prostate, ovarian and endometrial cancer xenografts in mice. The results in ovarian cancer were presented at the 2009 American Association in quest of Cancer Research (AACR) Annual Meeting. In in vivo studies, the efficacy of EP-100 in compare to saline or untargeted membrane-disrupting peptide or cisplatinum was studied in an ovarian cancer xenograft model (OVCAR-3). EP-100 regressed established OVCAR-3 xenografts following weekly injections at doses as low as 0.2 mg/kg bodyweight (p<0.03 vs. baseline). In comparison, tumor growth was observed across the saline control, untargeted membrane-disrupting peptide and cisplatinum arms. In addition, in the EP-100 arm tumor volumes, weights and CA125 (a clinical biomarker for ovarian cancer) were reduced. LHRH receptor levels were also reduced and PET imaging revealed that EP-100 treated tumors became necrotic, lacking viable tumor cells after treatment. EP-100 was well tolerated in all treated groups.

Esperance is using its CLYP(TM) technology to develop a robust portfolio of novel tMDPs to selectively destroy cancer cells that express target receptors. In addition to EP-100, Esperance has other drug candidates in preclinical stages, all of which have a unique targeting mechanism of action whereby candidates bind specifically and exclusively to surface receptors on cancer cells.

About Esperance Pharmaceuticals

Esperance Pharmaceuticals, Inc. is developing a new class of highly potent targeted anticancer drugs using its Cationic Lytic Peptide (CLYP(TM)) platform technology. These drug candidates, called targeted membrane-disrupting peptides (tMDPs), consist of a ligand component that binds to extracellular receptors on the cancer cell and a potent cytolytic peptide component that kills the cancer cell. Targeted MDPs, which are positively charged, specifically bind only to cancer cells that express the target receptors on their surfaces and interact with the negatively charged membranes of the cancer cells resulting in disruption of the cell membrane and causing the cancer cells to die by cell lysis. The drug candidates selectively kill cancer cells, including cells known to be resistant to chemotherapeutic drugs, exclusively of harming normal cells. In addition to EP-100, Esperance Pharmaceuticals has three other drug candidates in preclinical stages. The Company was founded on patented technology discovered by scientists at Louisiana State University. Founding investors include the Louisiana Fund I, Research Corporation Technologies and Themelios Ventures, LP — a venture fund managed by the principals of VCE Capital Partners, LLC. Additional investors include the Louisiana Technology Fund and private investors.

Source: Esperance Pharmaceuticals, Inc

Study Examines How Biotech Firm Partnerships With Developing Nations Can Help Increase Innovation, Revenue

By forging partnerships with developing countries, biotechnology companies from developed countries may have existence able to stay afloat during the circulating economic pass and bolster innovation, according to a study published Thursday in the magazine Nature Biotechnology, Livemint.com reports.

Of the 181 Canadian biotech firms included in the study by the McLaughlin-Rotman Centre on account of Global Health, researchers found the same in four had partnerships in the developing world. The findings also revealed that 47 percent of the firms have “manufacturing collaboration” by China and 43 percent regard “contract research activities” in India (Singh, 9/9). Firms also had collaborations in Latin America, sub-Saharan and North Africa, East Asia and the Pacific and the Middle East, according to a McLaughlin-Rotman Centre for Global Health/EurekAlert! give up (9/9). The firms with developing country collaborations moreover pulled in further average revenue than those without partnerships, $16.3 million compared to $4.4 million, Livemint.com reports.

According to the release, study co-author Peter Singer said, “The emerging economies used to be dismissively labelled ‘Rest of World’ in pharmaceutical circles and virtually ignored. But the so-called ‘Rest of the World’ has most of the people, most of the health problems, and most of the economic growth” (9/9).

The article includes advice on how collaboration is changing the highroad biotech companies in developing countries direct the eye to “secure of the intellect property in the North” to develop into products locally and the resulting joint products in the pipeline (9/9).

This knowledge of facts was reprinted from globalhealth.kff.org with sympathetic permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up in the place of email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

FDA Notifies Clinical Researcher of Disqualification Proceeding

FDA Notifies Clinical Researcher of Disqualification Proceeding
The FDA has told David Loucks, a drug clinical trial student from Centennial, Colo., that he faces possible disqualification for failing to properly supervise a study and allowing others to forge his signature on study documents, according to an Aug. 18 see posted recently on the FDA’sitting website. Loucks admitted in a May 7, 2008 affidavit that a account of cogitation documents were signed or initialed with his credit by other mob, the notice says.

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