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ChronSeal multi-center study in Sweden and Norway finalized

The multi-center study in Sweden and Norway with ChronSeal® is now finalized and the data are being analyzed in Sweden and by Kringle in Japan. ChronTech and Kringle have jointly decided that the results will be publicly available on May 27th. At follow-up of the ChronVac-C® -study where patients now have started treatment according to standard-of-care (interferon and ribavirin) all patients (100%) were virus free at treatment week 12 and 5/6 (83%) had less than 50 copies of virus/mL blood already at treatment week four.

28 Apr 2010

DARA Therapeutics collaborates to advance clinical study of KRN5500 for CIPN in cancer patients

DARA BioSciences, Inc. announced today that on April 26, 2010, DARA Therapeutics, a subsidiary of DARA BioSciences, and the Division of Cancer Prevention, National Cancer Institute (NCI), National Institutes of Health (NIH), entered into a Clinical Trials Agreement to advance the clinical study of KRN5500 for the treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN) in patients with cancer. Under the terms of the collaboration, NCI will fund the studies and DARA will supply KRN5500 and placebo.

28 Apr 2010

NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Cell Therapeutics, Inc. today announced that the North Central Cancer Treatment Group ("NCCTG") plans to conduct a Phase II study of brostallicin in combination with cisplatin in patients with metastatic triple-negative breast ("mTNBC") cancer, defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. Additionally, the majority of breast cancers that are associated with the susceptibility mutation (BRCA1) are of the triple-negative type.

28 Apr 2010

Lexicon Pharmaceuticals to present Phase 2 study results of LX1031 for non-constipating IBS at DDW 2010

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that the company will be giving poster and oral presentations on results from its Phase 2 clinical study with LX1031 in patients with non-constipating irritable bowel syndrome (IBS) at Digestive Disease Week (DDW) 2010 in New Orleans, Louisiana.

28 Apr 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies, a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.

28 Apr 2010

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Generex Biotechnology Corporation today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients. AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc., a wholly owned subsidiary of Generex, for multiple cancer indications.

28 Apr 2010

Debiopharm commences treatment in Phase I clinical trial for Debio 0932 small molecule Hsp90 inhibitor

Curis, Inc. announced today that its licensee Debiopharm S.A. has treated the first patient in a Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305.

27 Apr 2010

Alnylam Pharmaceuticals publishes encouraging results from Phase II GEMINI study in PNAS

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has published results from its Phase II GEMINI study in the Proceedings of the National Academy of Sciences (PNAS). These data, previously presented at the International Symposium on Respiratory Viral Infections in Singapore in 2008, showed human proof of concept with an RNAi therapeutic in a randomized, double blind, placebo-controlled study.

27 Apr 2010

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

Pluristem Therapeutics Inc. today announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia, the end-stage of peripheral artery disease. The interim data demonstrated that PLX-PAD is safe, well tolerated and effective.

27 Apr 2010

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

ViroPharma Incorporated today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema.

27 Apr 2010

Prime-boost malaria vaccine regimen provides sterile protection: Vical

Vical Incorporated announced today that a prime-boost malaria vaccine regimen provided sterile protection, with no disease symptoms and no detectable malaria parasites, in 4 of 15 vaccinated volunteers a full 28 days after challenge with multiple infected-mosquito bites.

27 Apr 2010

UK MHRA authorizes Presidio Pharmaceuticals to initiate Phase 1 clinical trial of PPI-461 for HCV

Presidio Pharmaceuticals, Inc. announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the initiation of a Phase 1 first-in-human clinical trial of PPI-461, an orally administered NS5A inhibitor for the treatment of hepatitis C virus (HCV). The Phase 1 clinical trial will be conducted in healthy volunteers.

27 Apr 2010

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, has received a grant of US$500,000 for its on-going Phase II clinical trial of DIABECELL in New Zealand from the Juvenile Diabetes Research Foundation International, a world leader in setting the agenda for diabetes research and the largest charitable funder and advocate for research in type 1 diabetes.

27 Apr 2010

Evotec to receive EUR 1.5M from German BMBF for advancing H3 receptor antagonist programme

Evotec AG today announced that it will receive funding of up to EUR 1.5 million from the German Federal Ministry of Education and Research (BMBF) to advance its H3 receptor antagonist programme into the clinic.

27 Apr 2010

Patient preference study results of Kristalose to be presented at 2010 Digestive Disease Week meeting

Cumberland Pharmaceuticals Inc. today announced that results from a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, will be presented at the 2010 Digestive Disease Week meeting in New Orleans.

27 Apr 2010

Phase 2b clinical study initiated to evaluate GI safety of LT-NS001

Logical Therapeutics, Inc., a Waltham, Mass.-based biotechnology company announced today the initiation of a Phase 2b clinical study to evaluate the gastrointestinal safety of its investigational drug LT-NS001 (naproxen etemesil). The study will compare the cumulative rate of gastric ulcers vs. Naprosyn after 12 weeks of treatment.

27 Apr 2010

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.

27 Apr 2010

OSI Pharmaceuticals completes enrollment in Phase III clinical trial of Tarceva

OSI Pharmaceuticals, Inc. announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva (erlotinib) as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer who have undergone surgery and have EGFR-positive tumors.

26 Apr 2010

First patient enrolled in Phase II clinical trial of E10030 for treatment of wet age-related AMD

Ophthotech Corp., a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, today announced that the first patient has been enrolled in its Phase II randomized, controlled clinical trial of E10030, an anti-PDGF aptamer, in combination with Lucentis® for the treatment of wet age-related macular degeneration (AMD).

26 Apr 2010

Phase 1/2 clinical trial of TRC105 therapy initiated for patients with castrate-resistant prostate cancer

TRACON Pharmaceuticals, a biotechnology company that develops targeted therapies for oncology and ophthalmology, announced today that the National Cancer Institute has initiated a Phase 1/2 clinical trial of TRC105 therapy for patients with castrate-resistant prostate cancer.

26 Apr 2010

Drug Trial News

ChronSeal multi-center study in Sweden and Norway finalized

DARA Therapeutics collaborates to advance clinical study of KRN5500 for CIPN in cancer patients

NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Lexicon Pharmaceuticals to present Phase 2 study results of LX1031 for non-constipating IBS at DDW 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

Phase I clinical trial results of AE37 in prostate cancer patients presented at EAU Congress

Debiopharm commences treatment in Phase I clinical trial for Debio 0932 small molecule Hsp90 inhibitor

Alnylam Pharmaceuticals publishes encouraging results from Phase II GEMINI study in PNAS

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

Prime-boost malaria vaccine regimen provides sterile protection: Vical

UK MHRA authorizes Presidio Pharmaceuticals to initiate Phase 1 clinical trial of PPI-461 for HCV

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Evotec to receive EUR 1.5M from German BMBF for advancing H3 receptor antagonist programme

Patient preference study results of Kristalose to be presented at 2010 Digestive Disease Week meeting

Phase 2b clinical study initiated to evaluate GI safety of LT-NS001

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

OSI Pharmaceuticals completes enrollment in Phase III clinical trial of Tarceva

First patient enrolled in Phase II clinical trial of E10030 for treatment of wet age-related AMD

Phase 1/2 clinical trial of TRC105 therapy initiated for patients with castrate-resistant prostate cancer

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