Drug Trial News

RSS

Sangart completes enrollment for MP4OX Phase IIa study in severely injured trauma patients

Sangart, Inc., today announced that enrollment was completed in a Phase IIa clinical study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. Complete study results are expected, after follow up of outcomes in these patients, in the second half of 2010.

30 Jun 2010

FDA grants IND regulatory clearance for Phase I/II clinical trial of AAT in type 1 diabetics

The U.S. Food & Drug Administration (FDA) has granted Investigational New Drug (IND) regulatory clearance to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in type 1 diabetics, based on research by Dr. Eli Lewis of Israel's Ben-Gurion University of the Negev.

30 Jun 2010

Cardio3 BioSciences reports positive data from C-Cure stem cell therapy clinical trial for heart failure

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular diseases, today announces positive safety data and preliminary efficacy results from its clinical trial of C-Cure(R), a breakthrough stem cell therapy for heart failure.

30 Jun 2010

Threshold Pharmaceuticals commences TH-302 Phase 1 clinical trial in patients with advanced leukemias

Threshold Pharmaceuticals, Inc., today announced that it has initiated a Phase 1 clinical trial of TH-302 in patients with advanced leukemias. TH-302 is a proprietary Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.

29 Jun 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.

29 Jun 2010

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

29 Jun 2010

Vitae earns $14M milestone payment from Boehringer Ingelheim

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has earned a $14 million clinical milestone payment from Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies. Vitae's 11beta-hydroxysteroid dehydrogenase (HSD)-1 is targeted for the treatment of diabetes and metabolic syndrome-related diseases in a strategic alliance with Boehringer Ingelheim. The payment recognizes Boehringer Ingelheim's recent advancement of a small molecule inhibitor of 11beta-HSD-1 into Phase I clinical trials.

29 Jun 2010

PROLOR Biotech receives EU GMP certification for hGH-CTP biobetter version of human growth hormone

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received formal Good Manufacturing Practice (GMP) certification for hGH-CTP, the company's proprietary biobetter version of human growth hormone. GMP certification is required by the European Union (EU) clinical trials legislation as a precondition for conducting clinical trials in EU member countries.

29 Jun 2010

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested were effective, safe and well tolerated.

29 Jun 2010

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs).

29 Jun 2010

Pluristem advances toward PLX-PAD Phase IIb clinical trials for CLI and Moderate-severe Claudication

Pluristem Therapeutics Inc. today announced that following its meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP), the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (CLI) and Moderate-severe Claudication.

29 Jun 2010

Scancell, immatics collaborate to develop ImmunoBody vaccines for colorectal cancer

Scancell Holdings Plc,, the developer of therapeutic cancer vaccines, today announces a research collaboration with immatics biotechnologies GmbH to explore the development of novel ImmunoBody® vaccines for colorectal cancer.

29 Jun 2010

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Astellas Pharma Inc. announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine.

29 Jun 2010

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced results from a second study of QPI-1007, a neuroprotective siRNA drug, in rat ocular hypertension model of glaucoma, conducted by Prof. Adriana Di Polo of the Department of Pathology and Cell Biology, Universite de Montreal.

29 Jun 2010

AFREZZA provides long-term glucose control in Type 2 diabetics: Study

AFREZZA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, as part of a diabetes treatment regimen, provides long-term glucose control comparable to usual insulin therapy but with a significantly reduced incidence of hypoglycemia and less weight gain in patients with Type 2 diabetes, according to a two-year study presented today at the American Diabetes Association's 70th Scientific Sessions.

29 Jun 2010

Avila's AVL-292 demonstrates disease-modifying effects in prophylactic, therapeutic models of rheumatoid arthritis

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, today announced results of preclinical studies demonstrating that its clinical candidate, AVL-292, potently inhibits B cell receptor signaling, and demonstrates efficacy in a rodent model of rheumatoid arthritis. These new data were presented Saturday, June 26, 2010 at the Federation of Clinical Immunology Societies (FOCIS) 2010 annual meeting in Boston, MA.

29 Jun 2010

Marcadia, Eli Lilly sign development, license agreement for short-acting glucagon program

Marcadia Biotech, Inc. and Eli Lilly and Company today announced that the companies have signed a development and exclusive license agreement for Marcadia's short-acting glucagon program, covering glucagon analogs that may provide greater convenience and ease-of-use than the current recombinant glucagon for the treatment of severe hypoglycemia. The program includes MAR531, a glucagon analog that is in preclinical development at Marcadia, as well as related backup compounds.

29 Jun 2010

Drug Trial News

Sangart completes enrollment for MP4OX Phase IIa study in severely injured trauma patients

FDA grants IND regulatory clearance for Phase I/II clinical trial of AAT in type 1 diabetics

Cardio3 BioSciences reports positive data from C-Cure stem cell therapy clinical trial for heart failure

Threshold Pharmaceuticals commences TH-302 Phase 1 clinical trial in patients with advanced leukemias

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alimera submits Iluvien NDA for DME to FDA

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Vitae earns $14M milestone payment from Boehringer Ingelheim

PROLOR Biotech receives EU GMP certification for hGH-CTP biobetter version of human growth hormone

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Pluristem advances toward PLX-PAD Phase IIb clinical trials for CLI and Moderate-severe Claudication

Scancell, immatics collaborate to develop ImmunoBody vaccines for colorectal cancer

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

AFREZZA provides long-term glucose control in Type 2 diabetics: Study

Avila's AVL-292 demonstrates disease-modifying effects in prophylactic, therapeutic models of rheumatoid arthritis

Marcadia, Eli Lilly sign development, license agreement for short-acting glucagon program

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

Latest News