* Advanced Tissue Sciences Inc., of La Jolla, Calif., presented data from pivotal and supplemental clinical trials of Dermagraft for the treatment of diabetic foot ulcers. Dermagraft, a living, fully human dermal skin replacement, proved significantly more effective than the control treatment. The severe ulcers were healed in 51 percent of the patients in 12 weeks. The FDA is reviewing a premarket approval application for Dermagraft.
* Ambi Inc., of Tarrytown, N.Y., was informed by the FDA that it can initiate a clinical trial under an investigational new drug application of orally administered nisin. Nisin, an orally delivered antimicrobial peptide, is a potential treatment for severe colon infections. It has been shown in preclinical studies to be more effective than vancomycin and metronidazole, and does not destroy helpful colon bacteria.
* American Biogenetic Sciences Inc., of Boston, introduced two patented in vitro diagnostic tests. TpP (thrombus precursor protein) tests for blood clot formation and monitors anticoagulant therapy. FiF (functional intact fibrinogen) measures fibrinogen, levels of which indicate an independent risk factor of cardiovascular disease.
* Celgene Corp., of Warren, N.J., and Cambrex Corp., of East Rutherford, N.J., signed a letter of intent for Cambrex to acquire Celgene's chiral intermediate business for about $15 million. Celgene's enzymatic technology, which produces chirally pure products for the pharmaceutical industry, will be included in the transaction. No property or technology related to Celgene's proprietary Ritalin and mexiletine will be included.
* CV Therapeutics Inc., of Palo Alto, Calif., said its in vivo study using its lead compound, CVT-313, inhibited the growth of vascular smooth muscle cells and the occlusion of arteries in the rat carotid artery model of restenosis. The drug showed a selective inhibiting effect on CDK2, an enzyme that plays a key role in cell proliferation. The findings were published in the Nov. 14 issue of The Journal of Biological Chemistry.
* Megabios Corp., of Burlingame, Calif., entered into a research collaboration and exclusive licensing agreement with the National Jewish Medical Research Center, in Denver, to investigate nonviral gene therapy for cancer by way of immunotherapy. The company also has entered into an agreement with Pat Walsh, of the University of Colorado Health Sciences Center, also in Denver, to conduct a clinical trial evaluating technology licensed from the research center. The university expects to file an investigational new drug application in the first half of next year.
* Octagen Corp., of Penn Valley, Pa., obtained from Emory University, in Atlanta, the rights to a new generation of potential treatments for hemophilia. Octagen's second- generation recombinant Factor VIII molecules, of which hemophiliacs have a shortage, are designed to reduce development of inhibitors that prevent treatment with often-used Factor VIII clotting agents. The Octagen Factor VIII molecules are in preclinical development.
* Pharmaceutical Product Development Inc., of Wilmington, N.C., signed an agreement to acquire Intek Labs Inc., of Cary, N.C., a provider of molecular genotyping, phenotyping and large-scale genomic DNA purification services. Intek supplies genotypes and phenotypes for difficult cellular and tissue samples such as liver, hepatocytes and S9 liver fractions. The company often provides pharmacogenetic services for clinical trials, including pediatric studies.
* The Immune Response Corp., of Carlsbad, Calif., initiated a Phase II trial in psoriasis patients of a T cell receptor peptide therapeutic vaccine. The vaccine consists of two T cell receptor peptides plus an adjuvant and is designed to turn off immune system cells linked to psoriasis.