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MAP Pharmaceuticals to present new analyses on LEVADEX from FREEDOM-301 Phase 3 clinical trial

MAP Pharmaceuticals, Inc. announced today it will present new analyses from the FREEDOM-301 Phase 3 clinical trial in a late breaker session at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California on Friday, June 25 from 3:30 to 4:00 pm PT. The presentation will show that the Company's investigational LEVADEX™ orally inhaled migraine therapy was effective irrespective of when it was administered during a migraine cycle.

23 Jun 2010

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

Groundbreaking studies will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer next week in Barcelona, Spain, including exciting new data on treatment for neuroendocrine tumors. "The presentations this year are very significant for clinicians, and outline real progress in the development of agents that are effective in managing and treating gastrointestinal diseases," says Eric Van Cutsem, MD, PhD of the University Hospital Gasthuisberg in Leuven, Belgium and Congress co-chair.

23 Jun 2010

Dapagliflozin as monotherapy demonstrates potential for type 2 diabetes treatment

Findings from a 24-week Phase 3 clinical study published online in the latest issue of Diabetes Care demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of glycosylated hemoglobin levels (HbA1c) in treatment-naïve adult patients with newly diagnosed type 2 diabetes, compared to placebo.

23 Jun 2010

Nymox reports positive new results from NX02-0014 follow-up study of NX-1207 for BPH

Nymox Pharmaceutical Corporation is pleased to report positive new results from the 48-60 month follow-up study of patients treated with NX-1207 in Study NX02-0014. The initial study, completed in the U.S. in 2006, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days post-treatment with NX-1207 2.5 mg.

23 Jun 2010

MJFF supports Ceregene's CERE-120 Phase 2 study for PD with $2.5M award

The Michael J. Fox Foundation for Parkinson's Research (MJFF) will provide $2.5 million to support Ceregene Inc.'s new Phase 2 study of CERE-120. This novel gene therapy product delivers the gene for neurturin, a potent neurotrophic (growth) factor that has shown potential to improve the status of degenerating neurons in both preclinical and clinical studies. CERE-120 has the potential to improve motor function as well as slow Parkinson's disease (PD) progression.

23 Jun 2010

Phase I/II clinical trials show crizotinib reduces lung cancer tumors

Patients with a specific kind of lung cancer may benefit from a Phase III clinical trial offered by the Moores UCSD Cancer Center. The new drug, crizotinib, under development by Pfizer, showed dramatic results in reducing lung cancer tumors in some patients during Phase I and II clinical trials.

23 Jun 2010

Mice treated with XOMA 052 experiences improvement in measures associated with diabetes: Endocrinology

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced the publication of data from a mouse model of diet-induced obesity in the June, 2010 edition of the journal Endocrinology. The data showed that mice treated with XOMA 052 both prophylactically and therapeutically experienced improvement in measures associated with diabetes and cardiovascular disease including reduction in glycosylated hemoglobin levels, improvement in glucose control, improved beta-cell survival and function, and a reduction in total cholesterol without reduction in high density lipoprotein.

23 Jun 2010

Cell>Point submits IND application for Phase 1b/2 99mTc-EC-G diagnostic trial in assessing CAD patients

Cell>Point announced today that it has submitted to the Food and Drug Administration an Investigational New Drug (IND) application for a Phase 1b/2 trial of its 99mTc-EC-G diagnostic in assessing patients with Coronary Artery Disease (CAD).

23 Jun 2010

Nuon study confirms potential utility of tranilast as uricosuric agent

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that results from clinical and preclinical studies demonstrating the ability of tranilast to reduce serum uric acid levels and monosodium urate crystal-induced inflammation - two important risk factors for gout - were presented at The European League Against Rheumatism (EULAR) 2010 Annual European Congress of Rheumatology in Rome, Italy, June 16-19, 2010.

22 Jun 2010

Affymax's database lock achievement in Phase 3 Hematide trial triggers $30M milestone payment from Takeda

Affymax, Inc. today announced that it has received $30 million in development milestone payments from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize Hematide™/peginesatide, Affymax's investigational drug for the treatment of anemia in chronic renal failure patients.

22 Jun 2010

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Neurologix, Inc., today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease, NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.

22 Jun 2010

Biovest targets mantle cell lymphoma as next indication for BiovaxID

Biovest International, Inc. (Other OTC:BVTI) today announced at the Active Immunotherapeutics Forum in Barcelona, Spain, that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID. At the conference, the Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care.

22 Jun 2010

Protea Biosciences, Mayoly-Spindler commence Phase I/IIA human clinical trial for new recombinant Lipase

Protea Biosciences, Inc., a leading developer of new technology for pharmaceutical research, announced today that the company, in partnership with Mayoly-Spindler, a European pharmaceutical company, has commenced a Phase I/IIA human clinical trial for a new recombinant Lipase.

22 Jun 2010

QLT reports final 24-month results from Phase II RADICAL study in patients with wet AMD

QLT Inc. today announced final 24-month results from the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions) in patients with exudative (wet) age-related macular degeneration. The purpose of the study was to determine if Visudyne® combined with Lucentis® reduced retreatment rates compared with Lucentis monotherapy, while maintaining similar vision outcomes and an acceptable safety profile.

22 Jun 2010

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the peer-reviewed journal Molecular Therapy has published a paper entitled "Comparative Analysis of Immune Responses Induced by Vaccination With SIV Antigens by Recombinant Ad5 Vector or Plasmid DNA in Rhesus Macaques." The paper, co-authored by researchers from Merck, University of Pennsylvania School of Medicine, and Inovio Pharmaceuticals, notes that significant advances in the design, formulation, and delivery of DNA plasmid-based vaccines have dramatically increased their ability to induce antigen-specific immune responses.

22 Jun 2010

Novel MC4R agonist exhibits potential as new treatment for obesity, diabetes

Rhythm, a biotechnology company developing peptide therapeutics for metabolic diseases, today announced a study of obese primates treated with RM-493 showing a reversal of obesity and insulin resistance, and improvement in both heart rate and blood pressure. RM-493 is a novel peptide agonist targeting the melanocortin 4 receptor (MC4R) that is a clinical candidate for the treatment of obesity and diabetes.

22 Jun 2010

Oral micronized progesterone effective for women with symptomatic hot flashes

Postmenopausal women who experience bothersome hot flashes or night sweats may have an alternative treatment to estrogen. According to a new study, oral micronized progesterone relieves those symptoms. The results will be presented Saturday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

Omega-3 effective for treating depression in patients without anxiety disorders

The use of Omega-3 supplements is effective among patients with major depression who do not have anxiety disorders, according to a study directed by Dr. Fran-ois Lesp-rance of the Centre de recherche du Centre hospitalier at the Universit- de Montr-al (CRCHUM), head of CHUM's Department of Psychiatry and a professor at the Universit- de Montr-al. The study was published June 15 in the online Journal of Clinical Psychiatry.

22 Jun 2010

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

BioSante Pharmaceuticals, Inc. commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD).

22 Jun 2010

Enobia reports positive interim data from ENB-0040 enzyme replacement therapy study for children with HPP

Enobia Pharma today announced positive interim data from a clinical study of ENB-0040, a bone targeted enzyme replacement therapy, under investigation for the treatment of hypophosphatasia (HPP). After 12 weeks of treatment with ENB-0040, children with HPP showed marked improvements in bone mineralization and function including increases in strength, endurance and mobility and reduction in pain. These findings were presented by Dr. Michael Whyte at ENDO 2010, the 92nd Annual Meeting of The Endocrine Society.

22 Jun 2010

Drug Trial News

MAP Pharmaceuticals to present new analyses on LEVADEX from FREEDOM-301 Phase 3 clinical trial

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

Dapagliflozin as monotherapy demonstrates potential for type 2 diabetes treatment

Nymox reports positive new results from NX02-0014 follow-up study of NX-1207 for BPH

MJFF supports Ceregene's CERE-120 Phase 2 study for PD with $2.5M award

Phase I/II clinical trials show crizotinib reduces lung cancer tumors

Mice treated with XOMA 052 experiences improvement in measures associated with diabetes: Endocrinology

Cell>Point submits IND application for Phase 1b/2 99mTc-EC-G diagnostic trial in assessing CAD patients

Nuon study confirms potential utility of tranilast as uricosuric agent

Affymax's database lock achievement in Phase 3 Hematide trial triggers $30M milestone payment from Takeda

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Biovest targets mantle cell lymphoma as next indication for BiovaxID

Protea Biosciences, Mayoly-Spindler commence Phase I/IIA human clinical trial for new recombinant Lipase

QLT reports final 24-month results from Phase II RADICAL study in patients with wet AMD

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Novel MC4R agonist exhibits potential as new treatment for obesity, diabetes

Oral micronized progesterone effective for women with symptomatic hot flashes

Omega-3 effective for treating depression in patients without anxiety disorders

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

Enobia reports positive interim data from ENB-0040 enzyme replacement therapy study for children with HPP

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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