¿ Aastrom Biosciences Inc., of Ann Arbor, Mich., initiated a Phase I/II safety and feasibility study of its CB-II Therapy Kit for the production of umbilical cord blood stem cells. The study will evaluate the rate of normal blood cell recovery and the survival rate of leukemia patients following AastromReplicell System-produced cord blood stem cell transplant.
¿ AltaRex Corp., of Waltham, Mass., entered a memorandum of understanding with Dompe Farmaceutici S.p.A., of Milan, Italy, to form a strategic business alliance for its lead product, OvaRex MAb, for Italy, Spain, Portugal, Switzerland, Austria and certain Eastern European countries. The memorandum gives Dompe the rights of first offer for additional cancer antibodies in the territory. Under the terms, Dompe has escrowed $5 million to purchase AltaRex common shares through a private placement at 55 cents per share. AltaRex plans to raise C$15 million (US$9.6 million) through the sale of stock and has filed a preliminary prospectus in certain provinces of Canada for a public offering. Also, Dompe has the option to purchase an additional $5 million in equity in a future public offering in the U.S. and will pay up to $1.25 million upon OvaRex MAb commercialization in Spain and Portugal.
¿ ChemBridge Corp., of San Diego, entered an agreement with Kirin Brewery Co. Ltd., of Japan, to give Kirin nonexclusive access to ChemBridge's PHARMACore combinatorial lead discovery library. Financial terms were undisclosed.
¿ Dianon Systems Inc., of Stratford, Conn., signed an exclusive third-party U.S. sales and distribution agreement with Response Genetics Inc. for Response's Danenberg Tumor Profile chemotherapy guidance system. Dianon made an equity investment in Response of $1 million in connection with the agreement.
¿ Discovery Laboratories Inc., of Doylestown, Pa., received clearance to begin a Phase II trial of Surfaxin, its peptide sinapultide, in acute respiratory distress syndrome. The randomized, dose-ranging, open-label, controlled, multicenter, 110-patient trial is designed to evaluate the compound's safety and efficacy.
¿ DNA Sciences Inc., of Mountain View, Calif., acquired rights to 152 variants in five separate genes associated with severe cardiac arrhythmias from the University of Utah and Yale University. DNA Sciences will develop and commercialize clinical management tests for physicians to use in identifying patients at high risk for Long QT syndrome, a potentially fatal disorder associated with erratic heartbeat.
¿ Exelixis Inc., of South San Francisco, said its joint venture with Bayer AG, of Leverkusen, Germany - Genoptera LLC - delivered novel insecticide targets for assay development to Bayer, triggering undisclosed milestone payments to Exelixis. Bayer has exclusive rights to commercialize insecticides based on Genoptera technology.
¿ Large Scale Biology Corp., of Vacaville, Calif., began clinical evaluation of its personalized vaccines against B-cell non-Hodgkin's lymphoma. The Phase I trial is designed to evaluate the vaccine's safety and preliminary immune response-generation ability.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, granted Eli Lilly and Co., of Indianapolis, a nonexclusive sublicense for the use of certain aspects of Lexicon's positive-negative selection and isotonic DNA technologies for use in Lilly internal discovery and target validation programs. Financial terms were undisclosed.
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it observed objective responses, defined as a 50 percent or greater reduction in tumor size, in 36 percent of 22 Stage IIIB or Stage IV non-small-cell lung cancer patients treated with squalamine combined with standard chemotherapy of carboplatin and paclitaxel. Overall, 31 percent of patients experienced objective responses at various doses of treatment.
¿ MGI Pharma Inc., of Minneapolis, and MethylGene Inc., of Montreal, initiated a Phase II trial of MG98, a second-generation mRNA inhibitor, in recurrent or metastatic squamous cell cancer of the neck and head. MG98 inhibits DNA methyltransferase by binding to mRNA, blocking the enzyme's production.
¿ Microbia Inc., of Cambridge, Mass., entered an exclusive license agreement with Harvard Medical School covering logic circuits of bacterial biofilm formation, in addition to compounds and methods for finding compounds that disrupt biofilms, highly differentiated communities of bacteria that develop on surfaces such as catheters and prosthetic implants. Financial terms were undisclosed.
¿ NPS Pharmaceuticals Inc., of Salt Lake City, said underwriters exercised their option to purchase an additional 600,000 shares at $42 per share for an additional $25.2 million in proceeds, bringing the total for the 4.6-million-share offering to $193.2 million. The offering was led by CIBC World Markets Corp., of New York, and co-managed by Prudential Vector Healthcare, of New York, and Robertson Stephens Inc., of San Francisco. (See BioWorld Today, Nov. 13, 2000.)
¿ Onyvax Ltd., of London, raised EUR17.5 million (US$14.9 million) through a private placement of EUR5 million apiece from MB Venture Capital Fund I; Merlin Biosciences Fund, of London; and 3i. S.R. One Ltd. contributed EUR1.7 million, and Alta Berkeley Venture Partners added EUR800,000. Onyvax said it will use the funding to pursue an aggressive program of clinical study and to expand its research and development team. The company is developing cancer vaccines.
¿ Targeted Molecules Corp., of La Jolla, Calif., formed a strategic partnership with Elan Corp., of Dublin, Ireland, to develop and commercialize aspects of TMC's peptide targeting technology and certain Elan drug delivery technology. The partnership has an initial term of three years and the companies will share ownership of the intellectual property and products developed. Financial terms were not disclosed.
¿ Trinity Medical Group USA, of San Rafael, Calif., said the government of Thailand approved an open-label availability program of immune-based therapy for HIV patients that will provide access to Remune to up to 10,000 individuals. The program, known as M903, is independent of Protocol 2101B, which was extended earlier this week. Remune is a product of The Immune Response Corp., of Carlsbad, Calif.