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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

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

29 Jun 2010

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, has presented 2 abstracts on Loramyc® and clonidine Lauriad® at the MASCC/ISOO 2010 International Symposium (Vancouver, June 24-26, 2010). These two products belong to the supportive care pipeline of BioAlliance Pharma.

29 Jun 2010

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP).

29 Jun 2010

Cell>Point completes cancer diagnostic phase 2 trial; reports favorable trends in primary tumor imaging

Cell>Point announced today that it has closed the Phase 2 portion of its Phase 2/3 trial of 99mTc-EC-G in evaluating patients with non-small cell lung cancer.

29 Jun 2010

ITMTX treatment effective in late stages/progressive forms of MS: Study

The Multiple Sclerosis Research Center of New York (MSRCNY), together with the International Multiple Sclerosis Management Practice (IMSMP), today announced that results from its Intrathecal Methotrexate Treatment in Multiple Sclerosis study have been published in this month's issue of Journal of Neurology. This study reports on the feasibility of using intrathecal methotrexate (ITMTX) in treatment unresponsive multiple sclerosis (MS) patients with progressive forms of the disease.

28 Jun 2010

Intarcia presents ITCA 650 Phase 2 study results at 70th ADA

Intarcia Therapeutics, Inc. presented today the results of a phase 2 clinical study of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in Orlando, FL (June 25-29, 2010). Results of the phase 2 study demonstrated substantial reductions in HbA1c and body weight during the 12 weeks of treatment with ITCA 650 at both the 20 mcg/day and 40 mcg/day doses.

28 Jun 2010

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

Zeria Pharmaceutical announced today positive results of their Japanese Phase III study of Z-338 (acotiamide hydrochloride hydrate; "acotiamide") for the treatment of functional dyspepsia (FD). FD is a gastrointestinal disease comprised of subjective symptoms including postprandial fullness, early satiation and epigastric pain without any organic abnormality on gastrointestinal tract.

28 Jun 2010

Drug Trial News

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

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Cell>Point completes cancer diagnostic phase 2 trial; reports favorable trends in primary tumor imaging

ITMTX treatment effective in late stages/progressive forms of MS: Study

Intarcia presents ITCA 650 Phase 2 study results at 70th ADA

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

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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