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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

Study indicates two treatment strategies can reduce progression of diabetic retinopathy

In high-risk adults with type 2 diabetes, researchers have found that two therapies may slow the progression of diabetic retinopathy, an eye disease that is the leading cause of vision loss in working-age Americans.

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

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

Rosiglitazone therapy associated with increased risk for heart attack: Study

Eleven years after the introduction of the diabetes drug rosiglitazone, data from available clinical trials demonstrate an increased risk for heart attack associated with its use and suggest an unfavorable benefit-to-risk ratio, according to a report posted online today that will appear in the July 26 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Simple blood test may help detect chromosomal abnormalities in developing foetus

Researchers in The Netherlands believe they are on the verge of developing a simple, prenatal blood test that would be able to detect accurately chromosomal abnormalities in the developing foetus.

29 Jun 2010

Artificial pancreas holds promise for treating Type 1 diabetes

Shawna Wood would like nothing better than to go back to bed for another 24 hours of perfect blood sugar control. The 50-year old Wilsonville, Ore. woman has Type 1 diabetes, and she recently took part in a clinical trial of an automated replacement for her pancreas, which stopped producing insulin 9 years ago.

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

Non-Invasive prenatal blood test to detect chromosomal abnormalities in foetus

Researchers in The Netherlands believe they are on the verge of developing a simple, prenatal blood test that would be able to detect accurately chromosomal abnormalities in the developing foetus. At present, the only reliable way to do this is through amniocentesis or chorionic villus sampling, both of which are invasive and carry the risk of triggering a miscarriage.

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

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

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

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

Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

Eisai Inc. and Morphotek®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.

28 Jun 2010

Aestus Therapeutics announces license agreement with Astellas Pharma

Aestus Therapeutics, Inc. announced today a license agreement with Astellas Pharma Inc. (Astellas; Tokyo, Japan) to provide Aestus with exclusive, world-wide rights to the Astellas product FK614. Aestus will develop the product as ATx08-001, a novel, first-in-class therapeutic for the treatment of neuropathic pain. The first clinical trial will start later this year.

28 Jun 2010

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today presented an analysis of baseline data from the Phase 3 DEFEND-1 clinical trial of otelixizumab in patients with autoimmune new onset type 1 diabetes.

28 Jun 2010

Wake Forest Professor awarded $2.8M NHLBI grant to study ways to make transfusions using older blood safer

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, announced June 21st that it will fund nine research grants to improve the safety of red blood cell transfusions.

28 Jun 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

28 Jun 2010

Clinical Trial News and Research

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

Study indicates two treatment strategies can reduce progression of diabetic retinopathy

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

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

Rosiglitazone therapy associated with increased risk for heart attack: Study

Simple blood test may help detect chromosomal abnormalities in developing foetus

Artificial pancreas holds promise for treating Type 1 diabetes

Scancell, immatics collaborate to develop ImmunoBody vaccines for colorectal cancer

Non-Invasive prenatal blood test to detect chromosomal abnormalities in foetus

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

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

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

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

Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

Aestus Therapeutics announces license agreement with Astellas Pharma

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

Wake Forest Professor awarded $2.8M NHLBI grant to study ways to make transfusions using older blood safer

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

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