Advanced Tissue Sciences, of La Jolla, Calif., and Smith & Nephew plc, of London, said interim data from a U.S. trial of Dermagraft in diabetic foot ulcers showed the living human dermal skin replacement did not offer statistically significant improvement. It showed Dermagraft was healing more ulcers than the control treatment at 12 weeks for all patients and healed approximately twice as many ulcers as the control treatment in diabetic foot ulcers having a duration of greater than six weeks, but not at statistically significant levels. Further discussions with the FDA are planned.
Alexion Pharmaceuticals Inc., of New Haven, Conn., said Phase I/II and IIa studies published in Circulation showed patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) who received a single dose of the complement inhibitor, 5G1.1-SC, had significant reductions in cardiac damage, new cognitive deficits and blood loss. Alexion and Procter & Gamble, of Cincinnati, are running a 1,000-patient Phase IIb study in patients undergoing CPB, and are initiating two additional 1,000-patient Phase II trials in heart attack patients.
AnorMED Inc., of Vancouver, British Columbia, said ZD0473, its platinum-based drug licensed to AstraZeneca plc, of London, entered Phase II trials in solid tumor indications. Multiple trials will be carried out in the U.S. and Europe evaluating the drug as a monotherapy.
Avanir Pharmaceuticals, of San Diego, signed a letter of intent with SmithKline Beecham for rights to market Avanir's docosanol 10 percent cream in the over-the-counter market as a treatment for oral herpes, or cold sores. Terms of the deal were not disclosed.
Biomira Inc., of Edmonton, Alberta, and collaborators showed they induced primary human CD4+ and CD8+ T-cell responses against cancer-associated MUC1 peptide epitopes in vitro following incubation of normal human antigen presenting cells with BLP25 liposomes followed by the addition of autologous T cells to the culture. Phase I trials are ongoing in patients with metastatic breast cancer.
Chiron Corp., of Emeryville, Calif., said it settled its lawsuit against Gilead Sciences Inc., of Foster City, Calif., related to infringement of Chiron U.S. hepatitis C virus protease patents. Terms include Gilead's admission of infringement and a lump-sum payment to Chiron. Gilead also assigned Chiron a co-ownership interest in its HCV protease inhibitor research results and, since it declined a license, Gilead agreed to stop screening for HCV protease inhibitors and will provide Chiron limited support for Chiron's research.
Chiron Corp., of Emeryville, Calif., said the Australian Red Cross Blood Service will use its nucleic acid testing system to screen the country's blood supply for hepatitis C and HIV. Chiron's combination HIV/HCV test, developed and manufactured by Gen-Probe Inc., of San Diego, should be fully implemented in Australia by mid-2000 and is expected to screen about 1 million blood donations there annually.
Ligand Pharmaceuticals Inc., of San Diego, received net proceeds of $13.9 million from the completion of the exercise of warrants that expired Dec. 18. About 2.3 million warrants, or two-thirds of those outstanding, were exercised at $7.12 each. They were issued through a Ligand/Allergan venture in 1995. (See BioWorld Today, June 6, 1995, p. 1.)
Oxford BioMedica plc, of Oxford, UK, acquired a human antibody, OBAb2, from a research group led by Hennie Hoogenboom at the University of Maastricht in the Netherlands. The company said it has high specificity for tumors.
Palatin Technologies Inc., of Princeton, N.J., said its common stock is now listed on the American Stock Exchange and trades under the symbol PTN. It was being traded over the counter.
Transkaryotic Therapies Inc., of Cambridge, Mass., said it earned a $2.5 million milestone payment from Aventis, of Frankfurt, Germany, when Aventis filed an investigational new drug application to begin Phase I studies of a second gene-activated protein product (GA-II). TKT has received $33.5 million from the potential $67 million deal signed with Aventis (then Hoechst) in 1995.
Vical Inc., of San Diego, said it will continue recruiting patients as planned in two ongoing registration trials of Allovectin-7 in metastatic melanoma, based on the recommendation of an independent Drug Safety Review Board. The board found the response rate in a single-arm expanded Phase II study warranted continuation, and that in that trial and a controlled Phase III there were no safety issues that necessitated modification or discontinuation.
Vical Inc., of San Diego, received a payment of $1.6 million from Merial, a joint venture between Merck and Co. Inc., of Whitehouse Station, N.J., and Aventis S.A., of Frankfurt, Germany, for the initial exercise of options under a 1995 agreement covering naked DNA vaccines for animal health applications. Merial retains for a limited time the option to acquire additional exclusive licenses to Vical's naked DNA technologies to develop DNA-based vaccines to prevent infectious diseases in domesticated animals.
ViroPharma Inc., of Exton, Pa., licensed inhalation drug delivery technology from a division of Battelle Memorial Institute, of Columbus, Ohio. ViroPharma will use the technology in combination with its small-molecule antiviral drug candidates for treating respiratory syncytial virus, and will be responsible for development through commercialization.
Xoma Ltd., of Berkeley, Calif., said the completion of laboratory tests confirmed that recombinant BPI21 in combination with anti-infective agents showed potent activity in vitro against a variety of gram-positive and gram-negative bacterial strains that cause eye infections. The result triggered the first milestone payment under Xoma's licensing deal with Allergan Inc., of Irvine, Calif.