Clinical Trial News and Research

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New form of immunotherapy increases survival in children with neuroblastoma

Administering a new form of immunotherapy to children with neuroblastoma, a nervous system cancer, increased the percentage of those who were alive and free of disease progression after two years, according to researchers at the University of California, San Diego School of Medicine and fellow institutions. The percentage rose from 46 percent for children receiving a standard therapy to 66 percent for children receiving immunotherapy plus standard therapy, according to the study published in the Sept. 30, 2010 issue of the New England Journal of Medicine.

30 Sep 2010

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced treatment of the first patient in a second Phase 3 clinical trial of the investigational drug MDV3100, which expands the Phase 3 development of the novel, triple-acting oral androgen receptor antagonist into an earlier-stage patient population. Known as PREVAIL, the trial will evaluate MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. Initiation of the PREVAIL trial triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

29 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

NIAID study utilizes Biojector B2000 system to explore syringe, needle benefits

Bioject Medical Technologies Inc., a leading developer of needle-free injection therapy systems, today announced that its unique Needle-Free Injection Therapy (NFIT) system, the Biojector 2000, is being utilized in a study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the U.S. National Institutes of Health (NIH).

29 Sep 2010

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

Rigel Pharmaceuticals, Inc. today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today.

29 Sep 2010

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, and South America.

29 Sep 2010

ZymoGenetics announces positive survival data from IL-21 Phase 2a clinical trial

ZymoGenetics, Inc. today announced positive survival data from a Phase 2a clinical trial in metastatic melanoma with recombinant Interleukin 21 (IL-21) as a single agent. Median overall survival was 12.4 months, and the percentage of patients surviving at 12 months was 53%.

29 Sep 2010

Cedars-Sinai physicians to lead St. Jude Medical's transcatheter aortic valve implantation clinical trial

St. Jude Medical, Inc., a global medical device company, today announced that physicians from the Cedars-Sinai Heart Institute will lead the company's transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude Medical transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.

29 Sep 2010

Scientists develop NIA assay to determine drug's differential effects in tumor cells

A novel technology can make nanoscale protein measurements, which scientists can use in clinical trials to learn how drugs work.We are making progress toward the goal of understanding how drugs work in different individuals, said Alice C. Fan, M.D., instructor in the division of oncology at Stanford University School of Medicine.

29 Sep 2010

Study finds broader statin use as a cost-effective way to prevent heart attack and stroke

A new analysis suggests that broader statin use among adult patients may be a cost-effective way to prevent heart attack and stroke. The Stanford University School of Medicine study also found that using a popular test - a screening for high sensitivity C-reactive protein, or CRP - to identify patients who may benefit from statin therapy would be cost-effective, but only under certain scenarios.

29 Sep 2010

Intrauterine devices for treatment of endometrial cancer

Intrauterine devices, originally developed as contraceptives, can also be used to treat and cure cancer of the endometrium according to new research published online in the cancer journal, Annals of Oncology today (Wednesday 29 September). The finding opens the way for young women with the disease, which affects the lining of the womb, to be treated without the need for a hysterectomy, thus preserving their fertility until they have had all the children they want.

29 Sep 2010

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

XenoPort, Inc. announced today that new data from its first clinical trial of XP21279, a Transported Prodrug of L-Dopa, in Parkinson's disease patients will be presented at the upcoming World Parkinson Congress meeting in Glasgow, Scotland.

29 Sep 2010

Further trials needed to determine clinical application of Abatacept in SLE

Results from a 12-month multi-center clinical trial did not show therapeutic benefit of abatacept over placebo in patients with non-life threatening systemic lupus erythematosus (SLE). Abatacept failed to prevent new disease flares in SLE patients tapered from corticosteroids in an analysis where mild, moderate and severe disease flares were evaluated together. Full details of the phase IIb clinical trial are published in the October issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

29 Sep 2010

RV262 Phase I study launched to evaluate DNA prime/MVA vector boost vaccine regimen for HIV

A Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost vaccine regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa and South America.

29 Sep 2010

HUYA, Quintiles announce agreement to develop HBI-8000 cancer drug

HUYA Bioscience International, the leader in U.S.-China pharmaceutical co-development, and Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today announced an agreement to co-develop a new cancer drug, HBI-8000, sourced in China by HUYA.

29 Sep 2010

PolyMedix begins PMX-30063 Phase 2 clinical trial for bacterial infections

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 2 clinical trial in Canada with its novel defensin-mimetic antibiotic, PMX-30063.

28 Sep 2010

Endo Pharmaceuticals to acquire Qualitest Pharmaceuticals

Apax Partners today announced that Endo Pharmaceuticals has entered into a definitive agreement to acquire Qualitest Pharmaceuticals for approximately $1.2 billion in cash. Qualitest, a portfolio company of Apax Partners since 2007, is the sixth largest generic pharmaceutical company in the U.S.

28 Sep 2010

Neuronix to present TMS treatment trial data for Alzheimer's disease at Geneva Congress

The results of a successful clinical trial using Neuronix Ltd., a developer of a patent-pending, non-invasive system for Alzheimer's Disease and related conditions, will be presented for the first time today at the annual Congress of the European Federation of Neurological Societies in Geneva, Switzerland.

28 Sep 2010

Clinical Trial News and Research

New form of immunotherapy increases survival in children with neuroblastoma

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

NIAID study utilizes Biojector B2000 system to explore syringe, needle benefits

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

ZymoGenetics announces positive survival data from IL-21 Phase 2a clinical trial

Cedars-Sinai physicians to lead St. Jude Medical's transcatheter aortic valve implantation clinical trial

Scientists develop NIA assay to determine drug's differential effects in tumor cells

Study finds broader statin use as a cost-effective way to prevent heart attack and stroke

Intrauterine devices for treatment of endometrial cancer

XenoPort to present XP21279 clinical trial data at World Parkinson Congress meeting

Further trials needed to determine clinical application of Abatacept in SLE

RV262 Phase I study launched to evaluate DNA prime/MVA vector boost vaccine regimen for HIV

HUYA, Quintiles announce agreement to develop HBI-8000 cancer drug

PolyMedix begins PMX-30063 Phase 2 clinical trial for bacterial infections

Endo Pharmaceuticals to acquire Qualitest Pharmaceuticals

Neuronix to present TMS treatment trial data for Alzheimer's disease at Geneva Congress

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