Advanced Viral Research Corp., of Yonkers, N.Y., said it began to recruit sites for its Phase II study of product R for the topical treatment of genital warts. The company submitted Phase I data to the FDA and no adverse comments were received from the FDA. Phase I results indicated that Product R was safe and well tolerated dermatologically in all the doses applied in the study.
Axcan Pharma Inc., of Mont Saint-Hilaire, Quebec, filed a marketing authorization application with the Evaluation of Medicinal Products Agency in Europe for the use of its photodynamic therapy, Photobarr (porfimer sodium), in high-grade dysplasia associated with Barrett’s esophagus. Axcan also was granted orphan status by the EMEA for Photobarr, which gives the company exclusive marketing rights for 10 years.
CellControl Biomedical Laboratories AG, of Martinsried, Germany, entered an agreement with BioInvent International AB, of Lund, Sweden, for BioInvent to complete large-scale cGMP manufacturing of CellControl’s ACA-125 antibody for Phase III trials, as well as to provide regulatory support. ACA-125 is an imitation of the natural antigen CA 125, which is present in 80 percent of ovarian carcinomas. When injected, the substance causes a specific immune reaction to CA 125 in the patient’s body.
Genmab A/S, of Copenhagen, Denmark, reported a number of patients in its HuMax-CD4 Phase II clinical trial for psoriasis have experienced long-lasting effects from the treatment. Of 68 patients treated with HuMax CD4, 19 achieved at least a 25 percent reduction of the industry-recognized PASI score at the trial endpoint at week seven (four weeks after the last treatment). Over half still maintained that score 12 weeks after the last treatment. Five patients maintained a 50 percent reduction of PASI 12 weeks later. Genmab announced the results of the Phase II trial in February.
Hemosol Inc., of Toronto, filed the final prospectus for its recently announced public offering of units for $22.05 million. The offering is expected to close on or about April 18. The company also entered into an agreement amending its $35 million senior credit facility and plans to begin drawing down funds in May. (See BioWorld Today, March 29, 2002.)
Hybrigenics SA, of Paris, raised EUR16.8 million (US$14.8 million) in a Series C round of capital funding. The placement was led by Life Sciences Partners, of Amsterdam, the Netherlands, and included new investors Banexi Venture Partners, of Paris, and funds managed by La Compagnie Financière Edmond de Rothschild. of Paris. Existing investors include IMH, of Hannover, Germany; Lombard Odier, of Geneva; and Alafi Capital, of Berkeley, Calif. Proceeds will be used to expand therapeutic target validation with an emphasis on Hybrigenics’ drug discovery programs in infectious diseases, cancer and metabolic disorders.
Pharmexa A/S, of Horsholm, Denmark, said the manufacturing of the AutoVac HER-2 protein pharmaccine was transferred to a contract manufacturer, and animal toxicology studies will begin this month with the goal of initiating clinical trials in early 2003. Pharmexa in-licensed AutoVac HER-2 protein from GlaxoSmithKline plc, of London, in June 2001. GSK has an exclusive option to negotiate a license for AutoVac for a period after Phase I. The option does not cover the AutoVac HER-2 DNA project now in Phase I/II trials.
RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., reported that a paper published in the current Experimental Eye Research further characterized the wound-healing properties of thymosin beta-4 (TB4) in animal models. Researchers reported that TB4 accelerated corneal re-epithelialization following alkali injury of the eye, considered among the most severe chemical eye wounds. The findings confirm and extend prior research that has shown that TB4 markedly accelerates wound healing by increasing epithelial migration and reducing inflammation, the company said.
Viventia Biotech Inc., of Toronto, reported at the American Association for Cancer Research meeting in San Francisco the second-generation single-chain version of its fully human 4B5 product for melanoma demonstrated greater humoral and cellular responses than its earlier hybridoma version as an anti-idiotypic vaccine approach to fight cancer. Animals immunized with the second-generation scFv version of 4B5 demonstrated stronger cell-mediated and humoral immune responses. A stronger anti-id response and a stronger anti-GD2 antibody response indicated this, results suggesting that the second-generation version of 4B5 has potential as a vaccine for immunotherapy.
Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, launched a U.S. division, Yamanouchi Pharma America Inc., of Paramus, N.J., to further advance the company’s global strategy for growth by increasing its presence in the U.S. pharmaceutical market, particularly in the field of urology. Yamanouchi Pharma America is designed to bring the parent company’s products directly into the U.S. market by establishing a fully integrated pharmaceutical company supported by two main divisions: research and development, and marketing and sales.