* AltaRex Corp., of Waltham, Mass., filed an investigational new drug application with the FDA to begin a Phase I clinical trial of its second antibody-based cancer product, BrevaRex MAb. The dose-comparison study will test the safety of the product in patients with metastatic cancer expressing the MUC1 antigen. BrevaRex is an activated murine monoclonal antibody that is developed from, and specifically binds to, the MUC1 tumor-associated antigen, which is expressed in a majority of breast, prostate, pancreatic, renal, lung and olorectal tumors.* Digene Corp., of Beltsville, Md., won FDA marketing clearance for the Hybrid Capture CMV DNA Test, a cytomegalovirus diagnostic. In a clinical trial, the product was 99 percent sensitive, an improvement over the current culture method, which was 46 percent sensitive. The CMV diagnostic is the first of Digene's blood virus testing line to achieve U.S. approval.
* Epix Medical Inc., of Cambridge, Mass., and Neo-Genesis Pharmaceuticals Inc., also of Cambridge, signed a collaborative agreement under which NeoGenesis will provide access to the NeoMorph combinatorial chemistry libraries and the Mass-Coded Drug Discovery Platform. Epix is looking for new contrast agents to use in magnetic resonance imaging.
* Introgen Therapeutics Inc., of Austin, Texas, is evaluating the anti-tumor activity of the Bak gene, discovered in 1993 by scientists at LXR Biotechnology Inc., of Richmond, Calif. The gene induces apoptotic cell death; is down-regulated in a number of tumor types, including colon cancer; and is believed important in regulating physiologic cell turnover in a number of organ systems. Introgen is paying an up-front fee for an option to license rights to the gene, and the agreement includes provisions for potential milestones and royalties.
* The Liposome Co., of Princeton, N.J., won Australian approval of Abelcet (Amphotericin B Lipid Complex Injection) for the first-line treatment of systemic fungal infections. The company said Amgen Inc., of Thousand Oaks, Calif., will market Abelcet in Australia through Amgen Australian Pty. Ltd. Abelcet is aimed at invasive fungal infections that occur primarily in patients whose immune systems are compromised, such as cancer patients undergoing chemotherapy, bone marrow transplant recipients, solid organ transplant recipients and AIDS patients.
* Quintiles Transnational Corp., of Research Triangle Park, N.C., exchanged stock to acquire Serval, a Paris-based French contract sales and marketing company that has 110 sales representatives. The company will be integrated into Innovex, Quintiles' service group specializing in product commercialization. The company expects the purchase "to be neutral to slightly accretive to ... earnings per share."
* Vimrx Pharmaceuticals Inc., of Wilmington, Del., reported success in a Phase I trial of VM301, a wound-healing agent, with encouraging safety data on both unbroken and broken skin in 30 volunteers. The trial was designed to evaluate the safety of three strengths of VM301 along with that of the ointment vehicle when applied topically daily for 21 days to unbroken skin and for five days to standardized partial thickness wounds. "Based on this excellent safety profile, we intend to proceed with a Phase II clinical trial immediately to evaluate the wound-healing efficacy of VM301," said David Jackson, Vimrx's chief scientific officer. The product is a semisynthetic derivative of a compound obtained from the sea whip.