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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

Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

Ipsen today announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer's Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer's Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study.

22 Jun 2010

Semafore's SF1126 peptidic prodrug demonstrates clinical activity in chronic lymphocytic leukemia

Semafore Pharmaceuticals today announced the presentation of preliminary clinical data demonstrating that SF1126 has clinical activity in chronic lymphocytic leukemia (CLL). SF1126 is a novel peptidic prodrug that converts to LY294002, one of the most widely studied small molecule inhibitors of both phosphatidylinositol 3-kinase (PI3K) and mammalian target of rapamycin (mTOR). The results were presented at Cambridge Healthtech Institute's 8th Annual Next-Gen Kinase Inhibitors Oncology & Beyond Conference being held June 21-23, 2010, in Cambridge, Massachusetts.

22 Jun 2010

Lexicon presents LX4211 Phase 2a clinical trial results for type 2 diabetes mellitus at ENDO 2010

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, presented clinical data and analysis from its Phase 2a clinical trial of LX4211 for patients with type 2 diabetes mellitus at ENDO 2010 today. The results reported today included newly-obtained data showing a trend of increased total GLP-1 in both LX4211 treatment arms relative to placebo as measured in a post-trial analysis of blood samples.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Sinapis initiates dosing in Phase I trial of intravenous infusion of methamphetamine

Sinapis Pharma, Inc. announces that its first patients were dosed in a Phase I clinical trial study on June 14, 2010. This study, in human volunteers, is designed to evaluate the safety, pharmacokinetics, and absolute bioavailability of an intravenous infusion of methamphetamine. The first cohort, investigating shorter infusion times, went well. Future cohorts will evaluate longer infusion times and higher drug doses.

21 Jun 2010

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante Pharmaceuticals, Inc., today announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study's unblinded safety data. The review was based on data from almost 1,500 women-years of exposure.

21 Jun 2010

Palatin reports preclinical study results of PL-3994 in respiratory tissue for asthma indications

Palatin Technologies, Inc. today announced results of preclinical studies in respiratory tissue with PL-3994. In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

21 Jun 2010

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

NanoViricides, Inc. reports that its anti-Dengue drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection. The studies were performed in the laboratory of Dr. Eva Harris, Professor of Infectious Diseases at the University of California, Berkeley.

21 Jun 2010

Phase IIb EMBLEM study results of epratuzumab in patients with SLE presented at EULAR 2010

Immunomedics Inc. today announced that clinical trial results from the Phase IIb EMBLEM study of epratuzumab, a monoclonal antibody targeting CD22, in patients with moderate-severe systemic lupus erythematosus were presented at the 2010 annual Congress of the European League Against Rheumatism in Rome, Italy.

21 Jun 2010

Drug Trial News

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

Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

Semafore's SF1126 peptidic prodrug demonstrates clinical activity in chronic lymphocytic leukemia

Lexicon presents LX4211 Phase 2a clinical trial results for type 2 diabetes mellitus at ENDO 2010

Celator announces expansion of research agreement with Cephalon

Sinapis initiates dosing in Phase I trial of intravenous infusion of methamphetamine

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

Palatin reports preclinical study results of PL-3994 in respiratory tissue for asthma indications

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

Phase IIb EMBLEM study results of epratuzumab in patients with SLE presented at EULAR 2010

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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