AuRx Inc., of Baltimore, said the Mexican Ministry of Health has given the company a protocol authorization for a Phase I/II trial for the AuRx HSV-2 theracine for prevention of recurrences of genital herpes. The trial will give data on the safety and dosage to be used in continuing trials to establish efficacy. AuRx is the exclusive licensee of a patent obtained by the University of Maryland School of Medicine covering the therapeutic and preventive use of a recombinant strain of herpes in which the oncogene has been deleted.
AxCell Biosciences Corp., of Princeton, N.J., said it achieved two key milestones in its collaboration with InforMax Inc., of Rockville, Md. The companies completed the implementation of new, advanced software systems at AxCell, thus keeping the collaboration on schedule to begin marketing its proteomics database product at the beginning of next year. The collaboration team installed the latest version of InforMax's GenoMax software at AxCell's laboratory in Newtown, Pa. The companies also have completed the prototype software for visualizing AxCell's proprietary Inter-functional Proteomic Database of protein-protein interactions.
Boston Life Sciences Inc., of Boston, said Inosine, one of its nerve growth factors, has stimulated substantial regrowth of severed spinal cord motor nerve fibers through the area of experimental injury. In a study, a hemi-transection of the corticospinal tract was made in rats and Inosine was administered to the motor cortex that gave rise to the transected fibers. After two weeks, four out of five treated rats showed evidence of new fibers coursing through the injury to re-establish their distal connections.
Cerus Corp., of Concord, Calif., said it received clearance from an independent Data and Safety Monitoring Board to continue its Phase III trials of the Intercept system for inactivating viruses, bacteria and other pathogens in platelets. The company, in collaboration with Baxter Healthcare Corp., of Deerfield, Ill., is developing the Intercept Blood Systems to protect against the transmission of infectious diseases through blood transfusions.
Maxygen Inc., of Redwood City, Calif., said it initiated an arbitration proceeding against Energy BioSystems Corp., of The Woodlands, Texas, in connection with Energy's claim that it developed a "new gene shuffling" technology. Maxygen alleges that Energy has breached confidentiality provisions and certain other terms of a development and license agreement between the two companies beginning in December 1997, pursuant to which Maxygen disclosed confidential information regarding its MolecularBreeding technology. Energy said it disputes the allegations and is confident they are without merit.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the SEC declared the company's registration statement effective as of April 27, registering the resale of its 5.5 percent subordinated convertible notes due Jan. 15, 2007 and of shares of its common stock issuable upon conversion by certain holders of the notes. The registration statement also registers the resale of Millennium's common stock issuable upon the exercise of certain outstanding warrants by the holders. No securities are being issued or offered by Millennium in connection with the registration statement. (See BioWorld Today, Jan. 12, 2000, p. 2.)
Oxford GlycoSciences plc, of Oxford, UK, said the medical journal, The Lancet, published the first clinical results of OGT 918 in Gaucher disease. The trial treated 28 Gaucher disease patients for a one-year period. Trial results demonstrated significant reductions in liver and spleen volumes and a trend to improvement in blood counts. Chitotriosidase, a protein marker of disease activity, also was significantly reduced.
QLT PhotoTherapeutics Inc., of Vancouver, British Columbia, said a civil suit has been filed by Massachusetts Eye and Ear Infirmary (MEEI) with respect to an ongoing ownership dispute involving U.S. Patent No. 5,798,349 issued to QLT, Massachusetts General Hospital and MEEI. QLT said it has negotiated in good faith to secure an exclusive license position to the co-ownership rights of both MGH and MEEI in return for a reasonable royalty on Visudyne (verteporfin) sales in the U.S. QLT successfully concluded negotiations with MGH to pay an appropriate royalty on U.S. Visudyne sales, it said, but the company has been unable to reach an agreement with MEEI based on comparable terms. The complaint is pending before the U.S. District Court of Massachusetts.
Repligen Corp., of Needham, Mass., said the FDA issued an approvable letter to its development partner ChiRhoClin Inc., of Silver Spring, Md. regarding a new drug application (NDA) for diagnostic applications of synthetic porcine secretin. The FDA's letter indicates the NDA can be approved upon the receipt of a satisfactory response to questions about the product and agreement upon product labeling and a product brand name. The company said it is preparing proposed labeling and the product brand name, Secretin-Repligen, for submission. The product is a chemically synthesized form of secretin that has been evaluated in clinical trials for pancreatic function assessment.
The Stanford University School of Medicine, of Stanford, Calif., said its researchers have solved the structure of the RNA polymerase protein. The polymerase copies genes from DNA to RNA. The structure provides the basis for understanding all gene activity in eukaryotic cells. The findings were published in the April 28 issue of Science.
Tm Bioscience Corp., of Toronto, and the Ontario Cancer Institute (OCI) Microarray Facility at Princess Margaret Hospital in Toronto entered into an agreement on DNA biochip technology. OCI will provide Tm with biochip development and technical services for its Tm-ONE DNA biochip technology access platform. The Tm-ONE platform provides early access for high-performance technologies that enable information output from DNA biochips or microarrays.
Xoma Ltd., of Berkeley, Calif., said Diagnostic Products Corp. (DPC), of Los Angeles, has introduced in Europe an automated laboratory diagnostic test for early diagnosis and prognosis of systemic gram-negative infections. The test was developed with Xoma's patented technology that uses lipopolysaccharide binding protein (LBP) as a biochemical marker of systemic exposure to gram-negative bacteria and endotoxin, a potent bacterial poison that can trigger deadly infectious complications. Xoma will receive royalties on LBP-related products sold worldwide by DPC.