¿ Albany Molecular Research Inc., of Albany, N.Y., signed a Cooperative Research and Development Agreement with the National Cancer Institute to develop anticancer compounds. Scientists from both AMRI and the National Cancer Institute will select available, non-proprietary compounds for biocatalytic derivative synthesis from the NCI¿s repository. AMRI will prepare derivatives of these lead compounds to identify new analogues that maintain promising anticancer activity. The NCI will conduct in vitro biological testing of the compounds produced by AMRI, including evaluation on human xenografts of 60 different types of human cancer cells.
¿ Amylin Pharmaceuticals Inc., of San Diego, filed a shelf registration statement with the Securities and Exchange Commission that, upon being declared effective by the SEC, would allow the company to issue from time to time up to 13.3 million shares of common stock. The nature and terms of any offering will be established at the time of sale. Proceeds of any offering are expected to be used to fund the company¿s research and development activities, principally AC2993, and for general corporate purposes.
¿ Antigenics Inc., of New York, announced the publication of clinical results of a malaria vaccine containing its immune response enhancer, QS-21, which showed significant protection against the most widespread and dangerous forms of malaria. The study, published in the Dec. 8 issue of The Lancet, is titled ¿Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomized trial.¿ GlaxoSmithKline plc, of London, is developing the vaccine.
¿ AVI BioPharma Inc., of Portland, Ore., released study results demonstrating that a combination of two of its Neugene antisense drugs had a synergistic effect in halting cell growth of refractory cancer cells in prostate cancer. In the study, a Neugene compound directed against c-myc, a gene involved in cell proliferation disorders such as cancer and cardiovascular disease, was combined with an additional Neugene agent targeting hormonal signaling. The combination effectively corrected imbalances in hormone or growth factor functions, thereby stopping unchecked cancer cell growth. The results were announced at the 10th International Conference on Gene Therapy of Cancer in San Diego.
¿ Bioject Medical Technologies Inc., of Portland, Ore., entered into an agreement with affiliates of Elan Corp. plc, of Dublin, Ireland, with respect to various matters previously in dispute regarding Elan¿s ownership interest in Bioject. Elan agreed to eliminate, on a prospective basis from October, the 9 percent dividend due Elan from its holdings in Bioject¿s Series A preferred stock, to terminate its 350,000 Series K warrants to purchase Bioject common stock and to partially exercise its Series P warrant to purchase 252,666 shares of Bioject common stock. In addition, if certain trading price conditions are met, Elan agreed to exercise the remaining 505,334 Series P warrants to purchase common stock over the next two years. Bioject issued to Elan additional shares of Series A preferred stock in respect to dividend obligations on the Series A preferred stock through October 2001, agreed to eliminate the redemption and mandatory conversion provisions of the Series A and Series C preferred stock held by Elan, and will withdraw its lawsuit to compel the redemption of the Series A preferred stock. Elan also acquired a six-month option to Bioject¿s Iject technology in connection with a drug compound yet to be identified.
¿ Cell Genesys Inc., of Foster City, Calif., reported further results of a Phase I/II trial of CG7870, an oncolytic virus engineered to target and destroy prostate cancer cells, which is being evaluated in patients with advanced prostate cancer. The updated findings demonstrated stabilization of prostate-specific antigen levels in six of 23 patients, or 26 percent, for a median duration of four months after only a single intravenous injection in patients with advanced hormone-refractory prostate cancer. The trial was a dose-escalation study designed to evaluate the safety and efficacy of CG7870.
¿ Demegen Inc., of Pittsburgh, entered a research collaboration with Farmacule BioIndustries, of Brisbane, Australia, and the Queensland University of Technology to develop disease-resistant bananas. The collaboration will focus on antimicrobial peptides. Demegen designs peptides that, when engineered for expression in plants, have shown promise to provide tolerance to various important plant diseases. Farmacule is an early stage company formed with technology licensed from the university that shows promise for allowing precise control of enhanced protein expression in plants, as well as allowing control of significant viral diseases of bananas.
¿ Entelos Inc., of Menlo Park, Calif., said it completed the third generation of its Entelos Obesity PhysioLab system, a computer model of human obesity. Entelos conducts collaborative research with pharmaceutical partners, as well as independent research, using the PhysioLab system, to explore theories on metabolism and weight loss. The PhysioLab is a large-scale model of human obesity that includes the functions and systems of whole-body metabolism. Using the PhysioLab, scientists can simulate the effects that diet, exercise and novel drug therapies have on normal and obese virtual patients.
¿ Hoffmann-La Roche Inc., of Nutley, N.J., researchers and scientists at the University of Ulm, of Basel, Switzerland, have had their findings published in the Dec. 13 issue of the journal Nature. Their findings are the first to show that the thymus ¿ the most important organ for the development of the specific T cells involved in immune responses ¿ can be regenerated from a cell type known as thymic epithelial cells. When transplanted into mice, thymic epithelial cells that have first been re-aggregated in vitro are capable of developing into a fully functional thymus gland.
¿ Human Genome Sciences Inc., of Rockville, Md., completed two permanent financings for its new research center, its first large-scale manufacturing plant and a research and development/corporate campus. The research center was financed through the Maryland Economic Development Corp., and will be leased under a long-term arrangement. Its $76 million financing was provided by AllFirst Bank. The manufacturing plant and campus¿ financing was achieved through a $450 million package negotiated with Fleet National Bank and First Union National Bank. The company has the option to buy the buildings and land at each of the three projects at the end of the respective lease periods.
¿ Neurocrine Biosciences Inc., of San Diego, announced results with all three doses of NBI-34060 Immediate Release relative to placebo in a Phase II study in the elderly population of primary insomnia. The study showed that it demonstrated a statistically significant effect on latency to persistent sleep relative to placebo with up to 61 percent improvement in the primary endpoint of latency to persistent sleep. Subjective latency to sleep onset was also improved significantly over placebo in a dose-response manner from 30 percent to 50 percent (p<0.004). Overall, NBI-34060-IR was found to be safe, well tolerated and without next-day residual sedation for all dose groups after approximately 270 administered doses.
¿ Orchid BioSciences Inc., of Princeton, N.J., granted a nonexclusive license to Quest Diagnostics Inc., of Teterboro, N.J., covering the commercial use of Orchid¿s SNP-IT technology for gene-based diagnostic testing services using SNAPshot reagent kits marketed by Applied Biosystems Group, of Foster City, Calif. Orchid received an up-front payment and will earn royalties on all diagnostic services performed by Quest using Orchid technology under this agreement. Further details were not disclosed.
¿ Oxford GlycoSciences plc, of Oxford, UK, said Pfizer Inc., of New York, extended its research agreement with OGS, which was renewed in 2000, and will provide funding for another year. OGS will continue to apply its industrial scale proteomics technology to the discovery and utility of biomarkers in atherosclerosis, Alzheimer¿s disease and certain other undisclosed targets and indications.
¿ Oxigene Inc., of Watertown, Mass., presented data from its next-generation vascular targeting agent, Oxi-4503, at the British Institute of Radiology meeting in London, showing that it induced complete regression of human breast cancer tumors, as well as several other tumors, grown in mice. Oxi-4503 has been shown to destroy blood vessels in all regions of the tumor including the periphery.
¿ Serologicals Corp., of Atlanta, said it completed its previously announced acquisition of the Intergen Company, of Purchase, N.Y., a privately owned supplier of a wide array of biological products, for $45 million in cash, less the amounts necessary to complete the expansion of Intergen¿s Toronto manufacturing facility.
¿ Vical Inc., of San Diego, said that Aventis Pasteur SA, of Lyon, France, is obtaining rights to use Vical¿s gene delivery technologies for specific oncology applications. In exchange, Aventis Pasteur is paying an undisclosed licensing fee and giving up rights to develop and commercialize infectious disease vaccines and gene-based therapeutics for neurodegenerative diseases that were previously licensed from Vical. Aventis Pasteur had originally obtained rights from Vical to develop DNA vaccines for malaria, cytomegalovirus, Helicobacter pylori, Lyme disease, herpes zoster and respiratory syncytial virus. (See BioWorld Today, July 10, 2000.)
¿ Zonagen Inc., of The Woodlands, Texas, said preliminary interim results from the gross necropsies of old and young rats exposed to various doses of phentolamine suggest that phentolamine does not induce or promote brown fat proliferations in the rat. No gross brown fat proliferations were observed during the entire one-year period that the animals were administered the drug. This study was initiated in November 2000, in an attempt to resolve the FDA¿s concerns regarding the appearance of brown fat proliferations in a prior two-year rat study. As a result of those findings, the FDA placed Vasomax on clinical hold, which was subsequently upgraded to a partial clinical hold. Vasomax is Zonagen¿s oral therapy to treat erectile dysfunction.