¿ Alfacell Corp., of Bloomfield, N.J., extended the expiration date of warrants to purchase an aggregate of 1,168,575 shares of common stock issued in a 1998 private placement from last Saturday to Aug. 17, 2001. As part of the Aug. 17 extension, the company also extended the expiration date of 114,708 units to purchase 229,416 shares of common stock and warrants to purchase an aggregate of 116,208 shares of common stock issued to the placement agent in the 1998 financing.
¿ American Biogenetic Sciences Inc., of Copiague, N.Y., said data from studies presented at recent medical conferences indicate promise for the company¿s Thrombus Precursor Protein test. The company said the studies illustrate the test¿s early detection of elevated levels of the thrombus precursor protein, which could result in identification of patients suffering from blood clots that potentially indicate a number of medical conditions ranging from heart disease to thrombophilias.
¿ Apomyx Inc., of North Logan, Utah, appointed Kent Schulze as the company¿s new CEO. He has worked in the seeds industry for more than 30 years.
¿ AtheroGenics Inc., of Atlanta, released preliminary results of a Phase II trial of AGI-1067, an oral agent for the treatment of restenosis after angioplasty. Results showed that six months after angioplasty, patients who received AGI-1067 had statistically significant greater luminal diameters of their coronary arteries than patients in the placebo group.
¿ AVI BioPharma Inc., of Portland, Ore., said it began a Phase I/II study of its Neugene antisense cancer drug at Oregon Health Sciences University in Portland. The study is designed to evaluate the use of the company¿s Oncomyc-NG antisense drug, which targets a disease-causing gene sequence, in up to 24 patients with either lung, breast, colon or prostate cancer.
¿ BioSource International Inc., of Camarillo, Calif., said CEO Russell Hays and Chief Operating Officer George Uveges both resigned, citing personal reasons. The company appointed Jean-Pierre Conte, current company board member, as interim chairman. James Chamberlain was named interim CEO.
¿ Cellomics Inc., of Pittsburgh, released Cellspace Knowledge Miner, a tool to directly access molecular cell biology information. The tool is available online.
¿ Centocor Inc.¿s infliximab (Remicade) was shown to prolong remissions in patients with moderate to severe Crohn¿s disease, a multicenter research team reported at the Digestive Disease Week meeting in Atlanta. The Malvern, Pa., company¿s drug was used in the 573-patient Accent-1 trial as a maintenance therapy instead of treatment for acute attacks.
¿ Entelos Inc., of Menlo Park, Calif., and Organon, of Oss, the Netherlands, entered into a research and development collaboration in rheumatoid arthritis. Entelos specializes in developing large-scale mathematics models of chronic diseases that have interacting physiologic systems.
¿ Exelixis Inc., of South San Francisco, Calif., said Bayer AG, of Leverkusen, Germany, accepted additional assays for high-throughput screening from Genoptera LLC, its $80 million joint venture with Bayer¿s crop protection division. Delivery of the assays triggered an undisclosed milestone payment to Exelixis.
¿ Genzyme General, of Cambridge, Mass., reported that a study by its scientists in Genetics in Medicine concluded that cystic fibrosis screening could be improved by using a test that includes a broad range of gene mutations.
¿ Genzyme Transgenics Corp., of Framingham, Mass., signed an agreement with a subsidiary of Elan Corp. plc, of Dublin, Ireland, to develop one of Elan¿s monoclonal antibodies being studied as a potential therapeutic treatment for an undisclosed disease. GTC will produce the antibody in specially bred goats that will express the therapeutic protein in their milk. The companies will pursue further agreements if the study is successful. It is their second antibody collaboration.
¿ GlycoDesign Inc., of Toronto, said that due to a packaging error, it anticipates a delay in the supply of its anticancer drug candidate GD0039 for some clinical trials in Europe and the United States. This means that clinical trials may be completed later than originally expected. The company¿s Phase I/II trial of GD0039 as a chemoprotectant in breast cancer patients receiving aggressive chemotherapy will not be affected by the packaging problem, it said.
¿ InforMax Inc., of Bethesda, Md., signed a license agreement with the 16-campus University of North Carolina system for its GenoMax enterprise software. Terms were not disclosed.
¿ InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., presented two Phase II studies demonstrating the safety and efficacy of Colirest in treatment of Crohn¿s disease and ulcerative colitis, at the Digestive Diseases Week meeting in Atlanta. The response rate after two months of therapy was 82 percent, the company said, and the data indicated a 64 percent remission rate as measured by the Crohn¿s Disease Activity Index.
¿ Maxim Pharmaceuticals Inc., of San Diego, said 72-week results from its completed Phase II study of Ceplene (histamine dihydrochloride) in combination with interferon-alpha in treatment of naove, chronically infected hepatitis C patients will be reported at the Digestive Diseases Week meeting in Atlanta. The company reported that 5 percent of patients treated with the Ceplene combination discontinued treatment due to adverse events, compared to 14 percent of patients treated with interferon-alpha alone.
¿ Neurocrine Biosciences Inc., of San Diego, said compounds from its CRF1 receptor antagonist programs demonstrated efficacy in preclinical models of irritable bowel syndrome. The study produced results that indicated a single oral dose of the CRF1 receptor antagonist produced a 12-fold reduction in colonic transit, restoring function to normal. The company¿s stock (NASDAQ:NBIX), which was upgraded by Robertson Stephens Inc., gained $6.59 Monday, or 21 percent, to close at $38.03.
¿ NexMed Inc., of Robbinsville, N.J., initiated a Phase II study of Femprox, a topical treatment under development for female sexual arousal disorder. The randomized, double-blinded, placebo-controlled study is designed to investigate the efficacy and safety of the Femprox cream in approximately 110 pre-menopausal women diagnosed with the disorder.
¿ Octagen Corp., of Bala Cynwyd, Pa., entered a collaboration with the University of Minnesota to develop gene therapy technology for treatment of hemophilia A and other genetically based diseases. The approach pioneered by the university involves blood outgrowth endothelial cells.
¿ Pangene Corp., of Fremont, Calif., launched its genomics web portal. Access to the company¿s gene cloning and drug development platforms now is available through a secure, web-based genomics interface called DirectGenomics. Account registration currently is free and can be accessed through www.DirectGenomics.com.
¿ Pozen Inc., of Chapel Hill, N.C., released results from its 972-patient Phase II trial of MT-400, its third product candidate being developed for the acute treatment of migraine. Results showed that MT 400 was significantly better than placebo with respect to the primary endpoint, sustained pain relief, and the secondary endpoints, including relief of pain, nausea and sensitivity to light and sound, two hours after dosing. The company said all results were statistically significant beyond the p<0.001 level vs. placebo. Significant pain relief (p<0.001) with MT 400 was seen between 30 and 45 minutes after dosing and was maintained throughout the remaining 24-hour post-dose period.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., said that a new study presented at the American Association for the Study of Liver Disease session at the Digestive Disease Week meeting in Atlanta showed significantly greater response rates in patients treated with a combination of Zadaxin, SciClone¿s lead immune system enhancer, and alpha interferon than those in patients treated with alpha interferon alone. The study was conducted in Turkey in patients with chronic hepatitis B that is anti-HBe-positive.
¿ The Immune Response Corp., of Carlsbad, Calif., released preliminary interim clinical results from an ongoing Phase II trial, indicating that treatment with Remune (HIV-1 Immunogen) appears to induce both allo- and HIV-specific cell-mediated immune responses. The 243-patient trial is designed to evaluate the efficacy of Remune in conjunction with antiretroviral drugs on viral load and CD4 cells.
¿ The Medicines Company, of Cambridge, Mass., entered into an exclusive marketing and distribution agreement with Medison Pharma Ltd., of Petach-Tikva, Israel, for the registration, distribution and promotion of Angiomax in Israel. Angiomax in December received approval from the FDA for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing coronary balloon angioplasty.
¿ Unigene Laboratories Inc., of Fairfield, N.J., said it successfully applied patented technology in preclinical studies to orally deliver two additional peptides. One is leuprolide, a peptide prescribed in injectable form for the treatment of prostate cancer and endometriosis. The second peptide is DDAVP, which is prescribed for the treatment of hemophilia, incontinence and certain forms of diabetes. Also, Unigene said the SEC declared effective its registration statement for a financing deal with Chicago-based Fusion Capital. Fusion Capital has agreed to purchase up to $21 million of Unigene¿s common stock over a 24-month period. (See BioWorld Today, Dec. 20, 2000.)