¿ Abgenix Inc., of Fremont, Calif., reported additional results at ASCO from a Phase II trial of ABX-CBL, a mouse antibody, in graft-vs.-host disease. Ten of 18 patients in the three higher-dose cohorts survived at least 100 days, compared to two of nine patients in the low-dose group. The company plans to start a Phase III trial after getting FDA approval.
¿ BioTransplant Inc., of Clarkstown, Mass., and Massachusetts General Hospital announced at a transplantation meeting in Chicago that they made significant advances in developing more clinically desirable protocols for inducing immune system tolerance to donor tissue. One of the highlights included improved regimens in animal models for establishing acceptance of donor tissues without the need for long-term immunosuppressive therapy.
¿ Celgene Corp.¿s Thalomid (thalidomide) resulted in significant improvements in two-thirds of 12 Crohn¿s disease patients treated in a pilot study. The improvements were based on disease index scores. Other investigators studying the Warren, N.J., company¿s product in Crohn¿s disease reported similar results at a digestive disease conference.
¿ CuraGen Corp., of New Haven, Conn., and academic and research collaborators said they completed comprehensive high-resolution genetic and radiation hybrid maps of the rat genome. The findings were presented at the Genome Sequencing and Biology meeting at Cold Spring Harbor Laboratories in New York, and will be published in the June issue of Genome Research.
¿ Genetronics Inc., of San Diego, said interim results from a Phase II trial of its Electroporation Therapy system in treating squamous cell carcinoma of the head and neck showed a clinical response was achieved in 64 percent of 42 tumors treated. The results were consistent with those from an earlier trial. The system incorporates intratumoral injection of a chemotherapeutic agent and a pulsed electric field, which increases permeability of the cell membranes to the drug.
¿ Genzyme Transgenics Corp., of Framingham, Mass., and Lonza Biologics, of Slough, U.K., signed a letter of intent to develop purification and production methods for therapeutic proteins, including monoclonal antibodies. Lonza¿s parent company, algroup lonza, will make a ¿significant¿ equity investment in Genzyme if certain goals are met. Access to Lonza¿s protein purification technology is expected to save Genzyme from having to invest in that infrastructure.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif., presented Phase III results at ASCO showing IntraDose (cisplatin/epinephrine) Injectable Gel resulted in reductions in tumor volume of 50 percent or more in 45 percent of 102 patients treated. Response rates were consistent across all treated tumor types, including breast, melanoma and esophageal. Median duration of response ranged from 36 days for esophageal tumors to 78 days for recurrent breast tumors. The product is a cisplatin and collagen gel designed for intratumor injection. Enrollment in registration-directed studies is expected to close by the end of the year.
¿ Medarex Inc., of Annandale, N.J., reported at ASCO that the anticancer antibody MDX-447 stimulated the systemic release of cytokines from the immune system in all late-stage cancer patients treated in a Phase I/II trial. About one-third of the 62 evaluable patients showed disease stabilization for at least 12 weeks.
¿ MedImmune Inc., of Gaithersburg, Md., and BioTransplant Inc., of Clarkstown, Mass., said a Phase I/II trial of the BTI-322 monoclonal antibody in combination with Prograf, a calcineurin inhibitor, after liver transplantation significantly lowered the incidence (by 70 percent) of histological organ rejection compared to Prograf alone. MedImmune also reported on another study that showed CytoGam, given after renal transplantation in patients with a high risk of cytomegalovirus infection, significantly lowered the incidence of several markers of CMV infection and organ rejection compared to standard intravenous immune globulin.
¿ Nexell Therapeutics Inc., an Irvine, Calif., subsidiary of Vimrx Pharmaceuticals Inc., said it was issued a license to market in Canada its Isolex 300 and Isolex 300i cell selection systems. The systems are approved in Europe and awaiting approval in the U.S.
¿ NuOncology Labs Inc., of Virginia Beach, Va., filed a registration statement with the SEC on Form 10SB, seeking to get a listing on the Nasdaq exchange. It now trades over the counter.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., licensed certain compounds from Pfizer Inc., of New York, for treating mild to moderate psoriasis. The compounds were synthesized during the companies¿ ongoing collaboration in the area of cancer. They are small-molecule inhibitors of both epidermal growth factor receptor and vascular endothelial growth factor receptor.
¿ Pangea Systems Inc., of Oakland, Calif., said Dow AgroSciences LLC, an Indianapolis-based subsidiary of The Dow Chemical Co., of Midland, Mich., licensed its bioinformatics software for use at multiple sites in the U.S. The license covers Pangea¿s GeneWorld, GeneMill and GeneThesaurus, as well as the Pathway Tools.
¿ Protein Design Labs Inc., of Fremont, Calif., and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., announced an agreement under which PDL will humanize PRO 140, Progenics¿ anti-CCR5 monoclonal antibody that has potently blocked HIV replication in the laboratory. Progenics will pay PDL a licensing and signing fee, and potentially pay milestones and royalties. Terms were not disclosed. PRO 140 is designed to block the fusion of viral and target cell membranes, an early step of the HIV replication cycle.
¿ SangStat Medical Corp., of Menlo Park, Calif., filed for 510(k) clearance with the FDA for Celsior, its solution for cardiac preservation in transplant settings. The company plans to conduct trials evaluating Celsior for lung transplantation as well as other organs.