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Patient enrollment completed in Phase 2b clinical trial for Pyridorin

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

10 Sep 2009

American Medical News examines clinical trials outsourcing

American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how it is less expensive for a drug company to conduct a trial in India, where it runs about $2,000 to track a patient through a trial, compared to the cost in the U.S., which is "10 times more."

9 Sep 2009

Phase II trial of ANA598 commenced by Anadys Pharmaceuticals

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.

9 Sep 2009

Protox Therapeutics to present TRIUMPH clinical study update

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that Dr. Fahar Merchant, President & CEO of Protox Therapeutics, will present at the 11th Annual Rodman & Renshaw Healthcare Conference.

9 Sep 2009

VIVUS' Phase 3 studies find Qnexa effective in tackling obesity

VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo.

9 Sep 2009

INSPIRE Phase I/IIa study data to be presented at ICAAC

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that data from an interim analysis of its INSPIRE Phase I/IIa study of HIV-infected patients with low CD4 T cell counts treated with a three injection cycle of the Company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), will be presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held September 12-15, 2009, in San Francisco, CA.

9 Sep 2009

Synexus on track to double its clinical trial capacity in South Africa, opens two new research centres in Pretoria

Manchester-based Synexus, the world’s largest multi-national company dedicated to the recruitment and running of clinical trials, celebrated the first phase of its South African expansion programme in Pretoria today.

From AES - Accelerated Enrollment Solutions 9 Sep 2009

Patient enrollment completed in Phase II clinical trial of bavituximab

Peregrine Pharmaceuticals, Inc. today reported completion of patient enrollment in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients.

9 Sep 2009

Amarillo Biosciences is midway in Phase 2 clinical study of interferon against H1N1

Amarillo Biosciences, Inc. (OTCBB: AMAR) today announced that a Phase 2 study of orally administered interferon-alpha for the prevention of influenza and winter colds has reached the midway point. The study in Perth, Australia achieved full target enrollment of 200 subjects and 98% of the subjects remain on study drug. Subjects in the study are receiving a lozenge containing interferon-alpha or a matching placebo once a day for 16 weeks.

9 Sep 2009

Preliminary Phase 3 clinical study results of T-Pred released

ISTA Pharmaceuticals, Inc., today announced preliminary results from two recently completed studies on its investigational ophthalmic product, T-Pred (prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension). The Company is developing T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infection exists, or there is a risk of bacterial infection.

9 Sep 2009

Can-Fite's Phase II clinical study of CF101 provides positive results

Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, an Israeli Biopharmaceutical company, announced today that its 75-patient Phase II clinical study with CF101 to treat patients with moderate to severe Psoriasis has successfully met its primary objectives.

9 Sep 2009

Phase 3 clinical trials of BHR-100 infusion to be initiated by BHR Pharma

BHR Pharma, LLC (BHR) announced today that it will initiate a global, Phase 3, multi-center pivotal trial (www.synapse-trial.com) to evaluate the effectiveness of its proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe traumatic brain injury (TBI) patients in early 2010.

9 Sep 2009

Study to test efficacy of lapatinib in advanced hepatocellular carcinoma

Use of the molecularly targeted agent lapatinib to delay tumor growth and improve the survival of patients with inoperable hepatocellular carcinoma, or liver cancer, only benefited certain subgroups of patients. While results of this study were largely negative, patients that exhibited toxicity from the drug in the form of a skin rash appeared to have a greater tumor response and longer survival.

9 Sep 2009

Phase III trials for CS-8958 neuraminidase inhibitor successful

Hovione is pleased to announce that its TwinCaps(R) inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir).

9 Sep 2009

Valeant develops an acne drug with a low concentration of BPO combined with clindamycin

One of the most widely prescribed drugs for acne vulgaris is benzoyl peroxide (BPO). However, at concentrations of 5-10%, BPO has the potential for skin irritation and dryness leading to poor patient compliance. Increasingly, BPO is combined with clindamycin in a fixed combination where the efficacy effects of the two ingredients are synergistic.

8 Sep 2009

Preliminary results of Phase III Gvhd trials announced by Osiris Therapeutics

Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced preliminary results for two phase III trials evaluating Prochymal for the treatment of acute graft versus host disease (GvHD). GvHD, the most common complication of bone marrow transplantation, is a life-threatening disease for which there is currently no approved treatment. Prochymal showed significant improvements in response rates in difficult-to-treat liver and gastrointestinal GvHD, however neither trial reached its primary endpoint.

8 Sep 2009

Opexa Therapeutics releases Phase IIb TERMS clinical study results

Opexa Therapeutics, Inc., a company developing Tovaxin, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS).

8 Sep 2009

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.

8 Sep 2009

Patient enrollment for Phase 2b study of PRX302 completed by Protox Therapeutics

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has completed patient enrollment in its multi-centre, double-blinded, placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide.

8 Sep 2009

Third human clinical trial of LigoCyte's norovirus vaccine started

LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo.

8 Sep 2009