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PDS Biotechnology's Versamune-based immunotherapy drug demonstrates safety in preclinical studies

PDS Biotechnology Corporation today announced that the company has completed GLP toxicology studies of its lead HPV-cancer product. The studies, which included pharmacokinetic (PK) and adsorption, bio-distribution and excretion (ADE) studies in addition to the evaluation of toxicity, all demonstrated a very safe profile of the drug and PDS Biotech's platform Versamune((TM)) technology.

6 Oct 2009

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

OncoGenex Pharmaceuticals, Inc. announced today that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. Food & Drug Administration (FDA) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment.

6 Oct 2009

EP-100 membrane-disrupting peptide drug for cancer being tested at TCRS

A new drug designed to "seek and destroy" common cancers such as breast, prostate, endometrial, pancreatic, ovarian, skin and testicular cancers is being tested at TGen Clinical Research Services (TCRS) at Scottsdale Healthcare.

6 Oct 2009

ThromboGenics presents Phase IIa microplasmin intravitreal injection trial results at the ASRS conference

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, today announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME).

6 Oct 2009

ArQule completes patient enrollment in ARQ 197 Phase 2 trial for non-small cell lung cancer

ArQule, Inc. (Nasdaq: ARQL) today announced that patient enrollment in a Phase 2 trial with ARQ 197 in non-small cell lung cancer (NSCLC) has been completed.

5 Oct 2009

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that results from a landmark, international Phase 3 study of the long-term safety and nutritional benefits of liprotamase for the treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) will be presented at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) being held October 15-17, 2009 in Minneapolis, Minnesota.

5 Oct 2009

VIVUS to present data on Qnexa at The Obesity Society meeting

VIVUS, Inc. today announced that data on Qnexa(TM), an investigational new drug, will be presented at the 27th annual scientific meeting of The Obesity Society (TOS) in Washington D.C. Wesley Day, PhD, vice president of clinical development at VIVUS, will present data from the company's two year long phase 3 obesity trials, and Dr. Timothy Garvey, MD, professor of medicine and chair of the department of nutrition sciences at the University of Alabama at Birmingham, will present data from the year long phase 2 study in type 2 diabetics.

5 Oct 2009

Phase 3 clinical study results of Ketotransdel topical cream to be presented

Transdel Pharmaceuticals, Inc. today announced that it will host a conference call and audio webcast on Tuesday, October 6, 2009 at 9:00 am, eastern, to announce the top-line results of its Phase 3 clinical study for Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain.

5 Oct 2009

Preclinical study results of AVL-181 protease inhibitor presented

Avila Therapeutics, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, pan-genotype, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181.

5 Oct 2009

Positive results from Peregrine's Phase II bavituximab trial for non-small cell lung cancer

Peregrine Pharmaceuticals, Inc. today reported additional positive results in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC). Data previously reported from the initial cohort of 21 patients in the study had indicated that 11 of 17 evaluable patients with locally advanced or metastatic NSCLC achieved an objective tumor response according to RECIST criteria.

5 Oct 2009

Cumberland to present clinical trial data of Caldolor at the AAPM annual meeting

Cumberland Pharmaceuticals Inc. announced today that data from two key clinical trials for Caldolor®, an intravenous formulation of ibuprofen approved for treatment of pain and fever in adults, will be presented at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting to be held in Phoenix, Ariz., on October 8-11, 2009.

5 Oct 2009

Prednisporin is a key asset in the proposed acquisition of Fovea by Sanofi-Aventis

CombinatoRx, Incorporated, today announced that its ophthalmic collaborator, Fovea Pharmaceuticals SA, has entered into a proposed acquisition with Sanofi-Aventis. A CombinatoRx-derived combination drug candidate, Prednisporin, (FOV1101), which is a fixed dose combination of prednisolone and cyclosporine, is the most advanced product asset in the Fovea pipeline, with Phase 2b clinical studies planned for the treatment of persistent allergic conjunctivitis.

5 Oct 2009

Seattle Genetics discontinues its SeaGen MARINER clinical trial for large B-cell lymphoma

Seattle Genetics, Inc. announced today that it has discontinued the SeaGen MARINER clinical trial based on a determination that the trial would be unlikely to meet its primary endpoint of superior complete response rate in the dacetuzumab combination arm as compared to the placebo combination arm.

5 Oct 2009

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.

5 Oct 2009

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

GlaxoSmithKline and XenoPort, Inc. today announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher.

5 Oct 2009

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

5 Oct 2009

Genentech announces two Phase III study results of Lucentis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced results from two Phase III studies of Lucentis (ranibizumab injection) in macular edema due to retinal vein occlusion (RVO), which showed, on average, patients given either of two doses of Lucentis had a clinically and statistically significant improvement in vision as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity (BCVA) at six months compared to patients receiving sham injections.

5 Oct 2009

Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

Xcellerex, Inc. and Itero Biopharmaceuticals, Inc. announced today that they have signed a Letter of Intent to enter into a strategic collaboration for the production of Itero’s lead product, an undisclosed commercially differentiated therapeutic protein. Itero will initiate technology transfer for the product to Xcellerex immediately.

3 Oct 2009

Bristol-Myers Squibb to present new data on BARACLUDE and other compounds at the AASLD 2009

New data on four Bristol-Myers Squibb Company (NYSE:BMY) compounds will be presented at the 60th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 30 to November 3.

3 Oct 2009

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

Cardium Therapeutics announced plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study. Based on guidance from Cardium's independent clinical data management company which is currently completing the statistical analysis of all data for the Matrix clinical trial, Cardium expects to receive the locked unblinded data set and be in position to announce preliminary results on or before October 14, 2009.

3 Oct 2009

Drug Trial News

PDS Biotechnology's Versamune-based immunotherapy drug demonstrates safety in preclinical studies

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

EP-100 membrane-disrupting peptide drug for cancer being tested at TCRS

ThromboGenics presents Phase IIa microplasmin intravitreal injection trial results at the ASRS conference

ArQule completes patient enrollment in ARQ 197 Phase 2 trial for non-small cell lung cancer

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

VIVUS to present data on Qnexa at The Obesity Society meeting

Phase 3 clinical study results of Ketotransdel topical cream to be presented

Preclinical study results of AVL-181 protease inhibitor presented

Positive results from Peregrine's Phase II bavituximab trial for non-small cell lung cancer

Cumberland to present clinical trial data of Caldolor at the AAPM annual meeting

Prednisporin is a key asset in the proposed acquisition of Fovea by Sanofi-Aventis

Seattle Genetics discontinues its SeaGen MARINER clinical trial for large B-cell lymphoma

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Genentech announces two Phase III study results of Lucentis

Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

Bristol-Myers Squibb to present new data on BARACLUDE and other compounds at the AASLD 2009

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

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