Afferon Corp., of Wayne, Pa., received approval to start Phase II trials with RTX (resiniferatoxin) for bladder indications in the U.K. and France. Afferon will study RTX in over 150 patients under four Phase II protocols at more than 20 centers in the U.S. and Europe. The placebo- controlled, double-blind, and randomized studies will evaluate several measures of incontinence, including the number of incontinent episodes, frequency and urgency. Trials are already under way in Belgium and Holland in both neurogenic and non-neurogenic patients with overactive bladder.
Cangene, of Toronto, submitted data from its Phase III trial of VZIG, its anti-chicken pox product, to Canadian regulatory authorities. The drug is to prevent chicken pox during pregnancy. VZIG (Varicella zoster immune globulin) is a highly purified and specialized antibody against the Varicella zoster virus that causes chicken pox. In addition, Cangene has received regulatory approval to start a comparative bioavailability trial of its human growth hormone product. The trial should start in August.
Chiron Corp., of Emeryville, Calif., signed two agreements to supply both bulk and finished vaccine products in China. The contracts - with Lanzhou Institute, a government affiliated institute, and Sino Pharma, a holding company owned by the University of Beijing and private investors - represent the first efforts to expand Chiron's vaccines presence in emerging markets. Financial terms were not announced.
Connetics Corp., of Palo Alto, Calif., entered into a development, commercialization and supply agreement for recombinant human relaxin (ConXn), a potential therapy for scleroderma and organ fibrosis, with Paladin Labs, of Montreal. Connetics will receive an initial payment of $800,000, which includes payments for development fees and an equity investment. Connetics will receive quarterly development payments and potential milestones of about $2.5 million. Paladin will be responsible for all development and commercialization activity in Canada and will pay royalty fees on all sales of relaxin in Canada.
Cytogen Corp., of Princeton, N.J., reported the results of research published in Cancer Research on prostate specific membrane antigen (PSMA). The research supports the board potential of PSMA as both a diagnostic and therapeutic agent for a wide variety of cancers. PSMA is a transmembrane protein that is found associated with both normal and cancerous prostate cells.
Maxim Pharmaceuticals Inc., of San Diego, expects to complete patient enrollment this week in its Phase II trial of Maxamine for the treatment of hepatitis C. The European Phase II trial with 125 patients is evaluating Maxamine therapy, which consists of the combination of Maxamine and interferon-alpha (IFN-a), in the treatment of chronic hepatitis C patients who have not previously received treatment with IFN-a.
MedImmune Inc., of Gaithersburg, Md., and Pasteur Merieux Connaught, of Swiftwater, Pa., presented data showing that a combination vaccine of decorin binding protein A and outer surface protein A is more efficacious in preventing infection by Borrelia burgdorferi and related species in mice than vaccination with either immunogen alone. B. burgdorferi is a bacterium that causes Lyme disease. The presentation was given at the International Conference on Lyme Borreliosis and other Emerging Tick-Borne Diseases in Munich, Germany.
NeuroVir Therapeutics Inc., of San Diego released preliminary results of a Phase I trial of G207, an anti-cancer product based on a tumor-killing herpes complex virus (HSV). G207 is a genetically engineered HSV that has been designed to selectively infect and kill tumor cells, while not invading and damaging normal brain tissue.
Pherin Pharmaceuticals Inc., of Menlo Park, Calif., entered into an agreement with Janssen Pharmaceutica, N.V., of Beerse, Belgium, covering proprietary vomeropherin compounds for the treatment of a broad range of anxiety disorders. Pherin will receive license fees, milestone payments and royalties on net sales of developed products. In addition, Johnson & Johnson Development Corp. purchased $1.5 million of Pherin's convertible preferred stock. Janssen is a subsidiary of Johnson & Johnson, of New Brunswick, N.J.
Ribozyme Pharmaceuticals Inc., of Boulder, Colo., raised $6.3 million with a secondary offering of 1.8 million shares of common stock to institutional investors. Proceeds are expected to be used to fund development expenses of Angiozyme, an anti-angiogenic cancer compound currently in clinical trials. Angiozyme is being developed through a joint venture with Chiron Corp., of Emeryville, Calif.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., completed a private placement of just over $2 million from institutions and investors. The offering consisted of 1.37 million shares of common stock, each accompanied by a warrant to purchase one share of common stock. Each unit was priced at $1.46, a 20 percent premium over the company's stock price on the closing day. The offering will fund operations thorough the end of 1999.
The Liposome Company, of Princeton, N.J., filed a new drug submission with the Therapeutic Products Programme for approval of Evacet, for first-line treatment of metastatic breast cancer in combination with cyclophosphamide, in Canada. Evacet is a liposomal formulation of the anticancer drug, doxorubicin. The company filed a new drug application with the FDA in December.
Theratechnologies, of Montreal, Quebec, completed a Phase I trial with ThGRF 1-44 (growth hormone-releasing factor) analogue. The trial showed that high single doses of ThGRF 1-44 showed good safety profile and caused no side effects in health volunteers, and that it has more GH-releasing activity than natural GRF. Among the possible indications for GRF compounds are cardiomyopathy, GH deficiency and conditions associated with muscle-wasting diseases.