¿ American Biogenetic Sciences Inc., of Copiague, N.Y., said it will reacquire the license rights for its neurological compound ABS-103 from Abbott Laboratories Inc., of Abbott Park, Ill. ABS-103 is designed for the treatment of epilepsy, bipolar mania and the prevention of migraine headache. The company said it planned to find a new partner.
¿ AtheroGenics Inc., of Atlanta, presented data it said confirmed that its lead compound, AGI-1067, met its primary endpoint in preventing restenosis in a Phase II clinical trial for post-angioplasty patients. Results from CART-1 (Canadian antioxidant restenosis trial) suggest that AGI-1067 had a direct anti-atherosclerotic effect on coronary blood vessels, consistent with reversing the progression of coronary artery disease. AtheroGenics said it will initiate a clinical study in December to study prospectively this direct effect on atherosclerosis. CART-1 was a 305-patient trial that compared three doses of AGI-1067 given for six weeks, to placebo and probucol, a drug that has been shown to prevent restenosis.
¿ Cambridge Antibody Technology Group plc, of Melbourn, UK, and Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., said they initiated a Phase I/II clinical trial to assess the safety and efficacy of the human anti-TGF_ monoclonal antibody CAT-192 for the treatment of diffuse systemic sclerosis. The partners have begun a randomized, double-blind, placebo-controlled trial to evaluate three different dose levels of CAT-192. Each of the total 36 patients will receive four infusions administered six weeks apart. The trial also will study the effect of CAT-192 on several clinical and biologic markers of disease progression.
¿ Cell Pathways Inc., of Horsham, Pa., said an Independent Data and Safety Monitoring Board recommended resuming enrollment in the company¿s Phase III lung cancer trial of Aptosyn (exisulind) and Taxotere. The double-blind, placebo-controlled Phase III study was initiated in March and is being conducted in patients with non-small-cell lung cancer. The company had suspended new patient enrollment in this study in early October. (See BioWorld Today, Oct. 8, 2001.)
¿ Cetek Corp., of Marlborough, Mass., signed an agreement with Lexicon Genetics Inc., of The Woodlands, Texas, to develop assays and perform high-throughput screens against several novel in vivo validated targets for the discovery of lead compounds from Lexicon¿s compound libraries. Financial terms were not disclosed.
¿ ChemNavigator Inc., of San Diego, and Alydar Pharmaceuticals Inc., of Mountain View, Calif., said they entered a one-year cheminformatics services agreement, with the option to extend to a second year. ChemNavigator will perform cheminformatics analysis on Alydar¿s Pheromics library of infochemicals to help pinpoint their therapeutic potential. ChemNavigator will use its iResearch System and its ChemGuide content databases to perform several billion chemical-structure analyses of Alydar¿s pheromics library, using more than 2 million chemical structure records in ChemNavigator¿s content databases.
¿ Cubist Pharmaceuticals Inc., of Lexington, Mass., was awarded two Small Business Innovation Research grants that could total $1.25 million should all funding be received from the National Institutes of Health. The first award is a two-year, Phase II grant titled ¿Development of SecA as an Antimicrobial Target.¿ The second award is a six-month, Phase I grant titled ¿Inhibitors of KDO8-Phosphate Synthase as Novel Antibiotics.¿ To date, Cubist has been awarded $3.75 million in SBIR grants.
¿ Cytomyx Ltd., of Cambridge, UK, launched the final two services in its target-to-screen technology platform. The company now offers a full integrated service for all stages of target discovery, validation and assay development in advance of high-throughput screening against compounds. The first of the new services is for mammalian cell line production. The second new service is for the production of recombinant proteins, for use in high-throughput screening, functional validation and structural biology.
¿ Eli Lilly and Co., of Indianapolis, and its researchers reported that ReoPro, a drug partnered with Centocor Inc., appears to improve survival for people with diabetes undergoing angioplasty procedures during acute myocardial infarction. In a pre-specified, six-month analysis of patients with diabetes from the ADMIRAL (abciximab before direct angioplasty and stenting in myocardial infarction regarding acute and long-term follow-up) trial, ReoPro-treated patients were less likely to die during the six months following the procedure (0 percent vs. 16.7 percent, p=0.02). The ReoPro-treated patients also fared better when looking at the combined endpoint of death, recurrence of heart attack and any urgent procedures to open coronary arteries (20.7 percent vs. 50 percent, p=0.02).
¿ EraGen Biosciences Inc., formerly of Alachua, Fla., expanded its discovery research facilities following consolidation of all operations to Madison, Wis. The new 20,000-square-foot office and laboratory space is in a new biotechnology center. EraGen is expanding to further develop its discovery and therapeutic research.
¿ Geron Corp., of Menlo Park, Calif., said all its remaining Series C convertible debentures and a portion, $10 million, of its Series D convertible debentures have been converted into shares of Geron common stock. The terms of the remaining Series D convertible debentures have been amended to extend their maturity. The remaining $15 million principal balance of Series D convertible debentures was amended to carry a 2.5 percent coupon, have a fixed conversion price of $20 per share and have the maturity date extended to June 2005. (See BioWorld Today, June 30, 2000.)
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, said results from a Phase II study in Plasmodium falciparum malaria-infected patients in Thailand with the company¿s lead investigational drug candidate, HE2000, an immune regulating hormone, showed that 17 of 21 patients achieved clearance of all malarial parasites. Fourteen of the 21 patients completely cleared malaria during the first two days of treatment with the compound. During the treatment, 19 patients reached the primary endpoint of a 50 percent reduction in parasite count. In addition, the compound was well tolerated and no drug-related serious adverse events were reported.
¿ Idun Pharmaceuticals Inc., of San Diego, presented evidence that caspase inhibitors decreased heart muscle damage following a simulated heart attack in rats. Follow-up experiments are under way in a pig model. The data were presented at the American Heart Association¿s annual meeting in Anaheim, Calif. The evidence showed that when an Idun compound was administered after blocked arteries had reopened, it reduced the amount of heart tissue damage by 27 percent in heart attacks that damaged a large portion of the heart, and 55 percent in those that damaged a small portion. Administration of the Idun compound also preserved the function of the heart.
¿ Immunex Corp., of Seattle, announced that Enbrel, a product it co-markets in North America with Wyeth-Ayerst Laboratories, a division of Madison, N.J.-based American Home Products Corp., showed in a Phase II trial that 80 percent of 20 patients receiving it for ankylosing spondylitis reached the composite endpoint of improvement. This result compared to 30 percent of 20 patients receiving placebo. Forty patients participated in the double-blind, placebo-controlled study.
¿ Maxygen Inc., of Redwood City, Calif., and Novozymes A/S, of Copenhagen, Denmark, said Novozymes will advance into development two additional enzyme product candidates that were developed using Maxygen¿s MolecularBreeding directed molecular evolution technologies. In addition, the companies expanded the market areas addressed by their existing industrial enzymes collaboration. With the expanded relationship, Maxygen will receive royalty payments on the sales of any products in the expanded industrial enzyme market areas. Additionally, Maxygen will have co-exclusive rights to use the MolecularBreeding technologies for certain new industrial enzyme markets.
¿ NeoGene Technologies Inc., of Irvine, Calif., presented data showing that the natural ligand, or trigger, of the P2Y12 purinergic receptor is ADP. NeoGene also discovered that the closely related molecule, ADP-glucose, can be used as a selective tool to study the function of this receptor. In a study conducted in rats, ADP-glucose showed the ability to relax constricted aortas, which offers an additional tool to develop novel drugs to treat cardiovascular disease. NeoGene said this novel G protein-coupled receptor is potently activated by ADP and was recently identified as the Gi-linked platelet ADP receptor, now designated P2Y12. The data were presented at the 31st annual meeting of the Society for NeuroScience in San Diego. Separately at the meeting, NeoGene¿s parent company, NeoTherapeutics Inc., presented data showing that its nephrology compound AIT-034 restores memory in aged animals and improves memory recall in young animals.
¿ Oncotech Inc., of Tustin, Calif., said it is collaborating with Southwest Oncology Group to carry out a clinical trial evaluating Oncotech¿s patented radiation resistance assay as a tool to predict radiation and chemotherapy resistance in patients with locally advanced Stage IIB-IVA primary cervical carcinoma.
¿ PharmaSonics Inc., of Sunnyvale, Calif., said it will receive two National Institutes of Health Small Business Innovation Research Phase II grants, totaling $1.5 million. The grants will enable continued development of the Intravascular Sonotherapy treatment to enhance the delivery of gene therapy for angiogenesis, without the need to use viruses as gene carriers or vectors. The grants will fund the current ultrasound device development efforts in the use of sonotherapy to enhance nonviral gene delivery for myocardial and peripheral vascular angiogenesis.
¿ ProteEx Inc., of The Woodlands, Texas, plans to initiate several projects and research collaborations with institutions at the Texas Medical Center in Houston. Five projects have been initiated at the university and include studies of processing of tumor suppressor proteins involved in nuclear regulation in colon cancer, proteomic analysis of phosphoproteins involved in immuno-suppressive disorders and proteomic analysis of nitrosylated proteins involved in renal and cardiovascular disease. Projects include proteomic studies to develop high-resolution cancer diagnostics and proteomic studies of drug resistance in leukemia.
¿ Protein Sciences Corp., of Meriden, Conn., said it closed a financing of more than $2 million in new equity and restructuring of its balance sheet to eliminate all $27 million in debt and preferences. Investors include new and existing investors. The company has a proprietary baculovirus expression vector system technology.
¿ Repligen Corp., of Needham, Mass., reported that studies in animals demonstrated that secretin specifically activates neurons in the amygdala, a part of the brain known to be important in social interactions. Secretin is being studied by Repligen for the improvement of social interaction in children with autism. Among other studies, its Phase II clinical trial demonstrated that a subset of the autistic patients showed a clinical response to secretin. Symptom improvements were measured with the Autism Diagnostic Observation Schedule.
¿ Sonus Pharmaceuticals Inc., of Bothell, Wash., said in a Phase I study of S-8184, a paclitaxel cancer product, one of 16 patients enrolled to date showed a partial tumor response, which is defined as a 50 percent or greater reduction in tumor area on two consecutive CT scans. The patient has non-small-cell lung cancer. A second patient had the same type of tumor response as indicated by one CT scan.
¿ SuperGen Inc., of Dublin, Calif., said data from an ongoing Phase II study of its oral anticancer compound rubitecan shows the drug is active and well tolerated in patients previously treated for advanced gastric adenocarcinoma with minimal toxicity. The data were presented in New York at the 19th annual symposium on Innovative Cancer Therapy for Tomorrow.
¿ Wilex AG, of Munich, Germany, said it entered into a license, sublicense and option agreement with Bayer Corp.¿s diagnostics group in Tarrytown, N.Y., to obtain certain rights under Bayer¿s MN patent portfolio. MN, also known as CA IX, is a tumor-associated antigen expressed in a large number of cancers, including virtually all renal cell carcinoma. Wilex receives certain intellectual property rights that protect its G250 antibody. Bayer also granted to Wilex option rights to develop certain other antibodies targeting the MN antigen, as well as certain diagnostic option rights.