Adventrx Pharmaceuticals Inc., of San Diego, said its registrational bioequivalence clinical study of ANX-530 (vinorelbine emulsion) met its primary endpoint and a new drug application will be submitted by the end of the year...In a separate presentation, Medivation reported clinical results of its Alzheimer's drug Dimebon, showing that it led to significant improvement in patients' ability to perform daily tasks over a one-year period compared to placebo

Apthera Inc., of Scottsdale, Ariz., presented results from analysis of a randomized safety and efficacy clinical trial studying NeuVax (E75) in the adjuvant treatment of early stage (node-positive and high-risk node-negative), HER2-positive breast cancer, showing patients with low-expressing HER2 tumors experienced decreased breast cancer recurrence and no mortality to date following treatment...Previously disclosed data showed MGCD0103's preliminary antitumor clinical activity in Phase II clinical

Cardiome Pharma Corp., of Vancouver, British Columbia, and partner Astellas Pharma US Inc., of Deerfield, Ill., said data from its first pivotal study of Kynapid (vernakalant hydrochloride) injection was published in Circulation, showing that the trial's primary efficacy analysis demonstrated that 75 of the 145 (51.7 percent) of the Kynapid patients in the short-duration atrial fibrillation group converted to sinus rhythm within 90 minutes of treatment compared to three of the 75 placebo

IDM Pharma Inc., of Irvine, Calif., said it has initiated enrollment in a clinical protocol finalized with the FDA for mifamurtide (L-MTP-PE...The clinical trial is being conducted in collaboration with Summit, N.J.-based Celgene Corp

The company plans to file a new drug application in the first part of 2010, Green told BioWorld Today...Akela Pharma Inc., of Montreal, said it has filed a final short-form prospectus and received a receipt from Canadian regulatory authorities for an offering of up to 7.5 million units, of which 3.75 million units are underwritten and up to 3.75 million units are offered on a best efforts basis at a price of C$1.20 per unit for aggregate maximum proceeds of C$9 million

Calistoga Pharmaceuticals Inc., of Seattle, said it has initiated a Phase I clinical trial of CAL-101, an orally available small molecule that inhibits an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta...The primary endpoint is time to last unformed stool, and secondary endpoints include clinical cure based on relief of symptoms and microbiological eradication rates...UCB Pharma Canada Inc., of Burlington, Ontario, said early data from a Phase IIIb study of

Amarillo Biosciences Inc., of Amarillo, Texas, said the FDA has allowed the investigational new drug application to test its low dose oral interferon in a Phase II hepatitis C clinical trial to go into effect...Hollis-Eden Pharmaceuticals Inc., of San Diego, has filed an investigational new drug application to begin clinical trials with its oral drug candidate Apoptone (HE3235) for the treatment of hormone receptor sensitive cancers...PLx Pharma Inc., of Houston, has initiated a Phase I clinical trial

Tranzyme Pharma, of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for TZP-102, a second-generation ghrelin agonist

N30 Pharma, of Boulder, Colo., said it successfully completed a Phase I study of N30-201, a compound being investigated to treat reactive and obstructive airway diseases, including cystic fibrosis and asthma...Trion Pharma GmbH, of Munich, Germany, said results of a Phase I trial showed that catumaxomab, a class of trifunctional antibodies, administered intraoperatively to patients with advanced gastrointestinal cancers was safe and well tolerated and led to substantial tumor cell destruction

The remaining trials should produce results in the first half of 2009, supporting a new drug application filing by the end of 2009...But many other biotech and big pharma options are in development, including Vivus Inc.'s Qnexa (phentermine and topiramate) and Arena Pharmaceuticals Inc.'s lorcaserin hydrochloride, just to name a few...Net proceeds of $97.5 million will be used for clinical trials of the company's antibody-based cancer and autoimmune disease drugs. (See BioWorld Today, Jan. 22, 2008

Novagali Pharma, of Evry, France, said the FDA has approved its investigational new drug application to conduct a Phase I clinical trial of Nova63035, an ophthalmic injectable emulsion based on Eyeject technology containing a corticosteroid prodrug for the treatment of diabetic macular edema, a severe form of diabetic retinopathy, a common complication of diabetes that affects about 50 percent of patients

The study also will measure the effect of Soliris on other clinical manifestations of PNH, including blood transfusion requirements, thromboses and kidney function...GTC's partner LEO Pharma A/S, of Ballerup, Denmark, has begun launching the product in Europe...MAP Pharmaceuticals Inc., of Mountain View, Calif., has initiated a Phase III clinical trial evaluating Unit Dose Budesonide (UDB), its nebulized version of budesonide, for the potential treatment of pediatric asthma

Preclinical development of that program is ongoing, and Catalyst anticipates filing an investigational new drug application in 2009...Ltd., of Ashiya, Japan, which was triggered when JCR filed notice to start clinical trials with Prochymal in graft-vs.-host disease in Japan

The firm anticipates submitting an investigational new drug application for NGX-1998, a dermally delivered liquid formulation of synthetic capsaicin...AspenBio Pharma Inc., of Castle Rock, Colo., closed its previously announced private placement, raising gross proceeds of $18.2 million through the sale of 2.5 million shares of common stock...Proceeds would be used for general corporate purposes, including clinical trials such as the ongoing Phase III study of recombinant plasma kallikrien inhibitor DX

Also in the works are plans to begin a Phase III clinical study of a twice-daily tramadol-acetaminophen combination formulation, a twice-daily acetaminophen formulation and a misuse-prevention platform...AspenBio Pharma Inc., of Castle Rock, Colo., entered into securities purchase agreements in connection with a private placement with a group of existing and new investors...The company said it will use the proceeds to advance its research in multiple myeloma with the goal of initiating a Phase I

Clinical Data Inc., of Newton, Mass., said it started a long-term safety study ahead of schedule for vilazodone, a treatment for depression that acts both as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A partial agonist...Nutra Pharma Corp., of Boca Raton, Fla., said its drug discovery arm, ReceptoPharm, successfully completed its six-month patient crossover in its Phase IIb/IIIa clinical trial of RPI-78M as a therapy for adrenomyeloneuropathy, a rare inherited metabolic disorder

DuoCort Pharma AB, of Helsingborg, Sweden, said enrollment is complete in the pivotal Phase II/III clinical trial evaluating 5-mg and 20-mg DuoCort dual-release hydrocortisone tablets for the treatment of adrenal insufficiency - the inability of the body to produce sufficient amounts of the essential hormone cortisol...The Phase I/II clinical trial is expected to enroll approximately 120 NHL subjects who have undergone two or more prior therapies and have relapsed or refractory disease

LifeCycle Pharma A/S, of Horsholm, Denmark, started a Phase II trial with LCP-Tacro, an immunosuppressant to prevent organ rejection in liver transplant recipients...The clinical trial is expected to enroll up to 50 patients in up to 12 centers throughout the U.S. The company expects to report clinical trial results in the first half of 2008

7TM Pharma A/S, of Horsholm, Denmark, said data from a double-blind, placebo-controlled, dose-ranging Phase I/II obesity trial showed that Obinepitide effectively inhibits food intake...BioAlliance Pharma SA, of Paris, said it has extended its ongoing acyclovir Lauriad Phase III trial in the treatment of oral herpes to the U.S. The 10 U.S...clinical centers will join the more than 40 in Australia and Europe already participating in the trial, with a target of 640 patients