* BioTransplant Inc., of Charlestown, Mass., received orphan drug designation from the FDA for its MEDI-507 antibody, when used as one of the components of the AlloMune transplantation system. The system is designed to allow long-term organ acceptance without the use of immunosuppressive drugs. MEDI-507, a humanized monoclonal antibody, is derived from BTI-322, a rodent antibody.
* Chrysalis BioTechnology Inc., of Galveston, Texas, said the FDA had cleared it to begin human trials to evaluate its lead compound, Chrysalin, for chronic diabetic ulcers. The company submitted an investigational new drug application in August. The combined Phase I and Phase II clincial study will test the topical applicatioin of Chrysalin to diabetic ulcers.
* Ergo Science Corp., of Charlestown, Mass., reported statistically significant results in a clinical trial of its timed, orally adminstered Ergoset (bromocriptine mesylate) tablets to improve insulin sensitivity for Type II diabetics. The placebo-controlled study was designed to determine the effects of the company's lead compound in combination with sulfonylureas on glucose tolerance, insulin secretion and insulin sensitivity. The 22 subjects tested over a four-month period were on a weight-maintaining diet.
* Hollis-Eden Pharmaceuticals Inc., of San Diego, said its research affiliate, Edenland Inc., of Ireland, began two Phase I/II clinical studies with about 40 HIV-infected, treatment-naive patients in South Africa, testing HE2000. The compound inhibits HIV replication by manipulating host cellular factors. Hollis-Eden also filed to begin a company-sponsored Phase I/II clinical trial in collaboration with the National Institute of Virology in South Africa.
* Perkin-Elmer Corp., of Norwalk, Conn., said it will distribute a new class of stock to track the performance of its newly created Celera Genomics Corp. business unit. The new stock is subject to shareholder and board approval. Celera was formed as a joint venture with The Institute for Genomic Research, of Rockville, Md. (See BioWorld Today, May 13, 1998, p. 1.)
* Vertex Pharmaceuticals Inc., of Cambridge, Mass., began Phase II trials of VX-497 in hepatitis C patients. The drug is an inhibitor of inosine monophosphate dehydrogenase, a human enzyme essential for production of nucleotides. Vertex believes the drug has potential against a variety of autoimmune diseases