Altair Nanotechnologies Inc., of Reno, Nev., named its new pharmaceutical for the removal of phosphate ions in kidney dialysis patients Renazorb. Developed to treat elevated phosphate levels in patients with end-stage renal disease undergoing kidney dialysis, it is a lanthanum-based ceramic microstructured material that binds phosphate and is designed to remove the ions in the gastrointestinal tract without absorption of the drug into the bloodstream.
AutoImmune Inc., of Pasadena, Calif., said its request to transfer from the Nasdaq National Market to the Nasdaq SmallCap Market was approved, effective tomorrow. Securities for the firm, which develops mucosally administered therapies to treat autoimmune and cell-mediated inflammatory diseases, will continue to trade under the symbol AIMM.
Avax Technologies Inc., of Overland Park, Kan., submitted to the FDA investigational new drug applications for M-Vax and O-Vax, its AC Vaccine technology product candidates to treat melanoma and ovarian cancers, respectively. Following a 30-day review period, Avax will begin clinical trials, it said.
Cellomics Inc., of Pittsburgh, released a pair of high-content screening bioapplication software products - Target Activation and the Compartmental Analysis. The former allows users to monitor fluorescence of cellular and intracellular spatial parameters in populations of living cells. The latter enables users to simultaneously quantify the presence of several different macromolecules in or between different regions or compartments in cells, the company said.
Cypress Bioscience Inc., of San Diego, completed enrollment in its Phase II trial of milnacipran in fibromyalgia syndrome (FMS) patients. The double-blind, placebo-controlled trial enrolled less than the original 200 patients originally expected, as a majority of those enrolled were able to escalate to the highest dosage - 200 mg/day - in the study. Cypress said it expects to report results from the trial early next year.
Forest Laboratories Inc., of New York, said a recently completed six-month Phase III study in patients with moderate to severe Alzheimer's disease showed a significant benefit to adding memantine treatment to a donepezil (Aricept) therapeutic regimen. The double-blind, parallel-arm trial enrolled 403 patients who were randomized to treatment with either 20 mg per day of memantine or placebo in addition to donepezil therapy.
GenoMed Inc., of St. Louis, reported publication in the August/September issue of Diabetes Technology and Therapeutics of its treatment method for chronic kidney disease. The study describes the use of two ACE inhibitors, quinapril and ramipril. GenoMed found that a higher dose of quinapril was effective in delaying chronic kidney disease due to diabetes or high blood pressure in both white and black men. Data also showed that if treatment was started early enough, kidney failure was reversed altogether.
Geron Corp., of Menlo Park, Calif., received a National Consortium Drug Discovery Group grant of about $800,000 to support the development of a telomerase inhibitor for the treatment of multiple types of cancer. Also, funds from the grant will be used to establish preclinical models for demonstrating safety and efficacy of such compounds.
Hollis-Eden Pharmaceuticals Inc., of San Diego, reported publication in the September issue of The Journal of Neuroimmunology of results demonstrating that investigational immune regulating hormones HE2200 and HE2500 delay, limit or prevent disease in experimental allergic encephalomyelitis, a preclinical model that mimics human multiple sclerosis. Results demonstrated that animals injected subcutaneously had delayed disease onset, reduced severity and limited relapses when compared to placebo-treated animals.
Ionix Pharmaceuticals Ltd., of Cambridge, UK, began a Phase I study for its intranasal opioid analgesic product. The program centers on an intranasal formulation of an established opioid agonist. Also, Ionix entered an agreement with West Pharmaceutical Services Inc., of Lionville, Pa., related to the formulation of Ionix's intranasal opioid products. The agreement gives Ionix the right to acquire worldwide commercial rights to the intranasal opioid formulations. Financial terms were not disclosed.
Maxim Pharmaceuticals Inc., of San Diego, said a Data Safety Monitoring Board reported no safety concerns associated with the triple-drug combination of Ceplene (histamine dihydrochloride), Peg-Intron (peginterferon alfa-2b) and Rebetol (ribavirin) in Maxim's Phase II trial of Ceplene to treat hepatitis C nonresponder patients. The randomized, controlled study, which is expected to include up to 282 patients, is designed to compare treatment with the triple-drug combination vs. treatment with Peg-Intron and Rebetol combination therapy alone.
Medivir AB, of Huddinge, Sweden, said CEO Jonas Frick is leaving the company to become a senior partner at a new venture capital fund. Medivir said it has begun its search for a successor. Frick, who has held the position since the company went public in 1996, remains at his post during his six-month notice period.
NeoGenesis Pharmaceuticals Inc., of Cambridge, Mass., earned from Mitsubishi Pharma, of Tokyo, an undisclosed milestone payment after delivering lead molecules for a target related to human cardiovascular disease. The companies entered the partnership last August to discover small-molecule drug candidates. Based on the rapid rate of the completed work, the partners expanded the collaboration agreement, with NeoGenesis now working to optimize the lead compounds, NeoGenesis said. (See BioWorld Today, Aug. 16, 2002.)
New Drug Associates Inc., of Framingham, Mass., licensed from the University of Alabama at Birmingham technology that targets a lipoprotein remnant. The technology comprises a series of small peptides that mimic the function of Apolipoprotein E, a protein needed for targeting cholesterol and triglyceride rich lipoproteins to the liver. Financial terms were not disclosed.
Novavax Inc., of Columbia, Md., submitted to the FDA a new drug application for Estrasorb, an estradiol topical emulsion being developed for short-term use in the reduction of vasomotor symptoms in menopausal women. The submission comes less than five months after the FDA requested additional information with respect to the chemistry manufacturing and controls section of the initial filing. Since Novavax voluntarily withdrew its first application, additional laboratory work included validating a stability-indicating method and performing content uniformity testing, it said.
Senesco Technologies Inc., of New Brunswick, N.J., said its patent-pending gene, apoptosis eucaryotic Initiation Factor 5A, has been shown to kill human cancer cells in preclinical experiments performed with cell lines derived from tumors. The gene was isolated and identified in human cells. Based on such findings, Senesco began live animal tumor studies to elucidate the gene's role and its mechanism of action.
Synaptic Pharmaceutical Corp., of Paramus, N.J., appointed Errol de Souza president and CEO, and he will join the board. He succeeds Kathleen Mullinix, who resigned from the roles in November. Previously, de Souza held senior management roles with Aventis SA, of Frankfurt, Germany. Synaptic uses its GPCRs as targets for therapeutics.
Tranzyme Inc., of Birmingham, Ala., entered an alliance with BD Technologies, a unit of Becton, Dickinson and Co., of Franklin Lakes, N.J., to develop products for drug discovery as well as cell and tissue engineering. BD will use Tranzyme's gene delivery and expression technologies, TranzVector and TExT. BD would have the rights to market commercialized products and would pay Tranzyme a fee on the sale of each product. Also, BD would provide Tranzyme access to undisclosed intellectual property for Tranzyme's internal drug discovery programs. Specific financial terms were not announced. Separately, Tranzyme said it opened a lab in BD's incubator facility in Research Triangle Park, N.C.
Xoma Ltd., of Berkeley, Calif., and Biosite Inc., of San Diego, said they resolved all outstanding disputes regarding patent and licensing issues. Xoma will receive a royalty-free, irrevocable and perpetual license to practice Biosite's Dower patents. Biosite will receive a nonexclusive license to the assigned patent rights. Biosite will receive a royalty-free, irrevocable and perpetual license to use Xoma's bacterial cell expression technology to produce antibodies and to develop new antibody products. Xoma will have the right to present an agreed upon number of targets to Biosite and receive expression libraries including screened high-affinity antibodies for each target. Xoma's license to Biosite for the LBP diagnostic assay is terminated by mutual agreement. No further terms were disclosed.