Clinical Trial News and Research

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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

ADVANCE study provides new insights into the management of SHPT in CKD patients

Results from the ADVANCE study presented in a late breaking clinical trial session at the ERA-EDTA 2010 Congress provide new insights into the management of secondary hyperparathyroidism in chronic kidney disease patients. ADVANCE (A randomiseD VAscular calcificatioN study to evaluate the effects of CinacalcEt) is a randomised, controlled open label study to evaluate the effects of treatment with Mimpara (cinacalcet) plus low-dose vitamin D, compared to flexible doses of vitamin D alone, on the progression of vascular and valvular calcification in dialysis patients with SHPT.

28 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Arena's lorcaserin reduces body weight across patient subgroups

Arena Pharmaceuticals, Inc. today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Novo Nordisk today presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association.

28 Jun 2010

New affiliation formed to accelerate nation's progress in fighting HIV/AIDS

Two leading institutions in public health and health policy are joining forces to accelerate the nation's progress in fighting HIV/AIDS, hepatitis C and tuberculosis in Washington – the Forum for Collaborative HIV Research and the University of California, Berkeley, School of Public Health.

28 Jun 2010

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor, for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models.

28 Jun 2010

Phase 2b clinical trial data of SGLT2 inhibitor in patients with type 2 diabetes presented at ADA 2010

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that canagliflozin, an investigational, oral, selective sodium-glucose transporter-2 inhibitor, improved glycemic control, and was also associated with a decrease in body weight, in a Phase 2b dose-ranging trial in patients diagnosed with type 2 diabetes who were concurrently treated with metformin. The data were presented at the 70th American Diabetes Association Scientific Sessions.

28 Jun 2010

Clinical Trial News and Research

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

ADVANCE study provides new insights into the management of SHPT in CKD patients

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Arena's lorcaserin reduces body weight across patient subgroups

FDA grants orphan drug designation for Chiasma's Octreolin

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

New affiliation formed to accelerate nation's progress in fighting HIV/AIDS

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Phase 2b clinical trial data of SGLT2 inhibitor in patients with type 2 diabetes presented at ADA 2010

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