¿ Aeterna Laboratories Inc., of Montreal, said the Phase III trial of its antiangiogenic drug Noevastat/AE-941 in renal cell carcinoma is under way in the U.S., Canada and Europe. Patient recruitment is under way, and should be complete by summer 2001. Final results are expected about a year later.
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., said results of in vivo studies on its small-molecule osteoporosis drug demonstrated inhibition of bone breakdown and stimulation of new bone formation. Clinical trials of Ariad's new osteoporosis product candidate are being planned for next year.
¿ Aronex Pharmaceuticals Inc., of The Woodlands, Texas, said researchers from the Intituto Nacional de Enfermedades Neoplasticas in Lima, Peru, found that Atragen used as a monotherapy as a treatment for patients with acute promyelocytic leukemia (APL) demonstrated potential to induce complete remission. Aronex submitted an amendment to its NDA for Atragen in July for the treatment of patients with APL for whom therapy with tretinoin is necessary, but for whom an intravenous administration is required.
¿ Avant Immunotherapies Inc., of Needham, Mass., initiated a Phase IIb study of its cholera vaccine candidate, Peru-15, to evaluate safety, immunogenicity and the protective capacity of the vaccine against a challenge of live virulent cholera. Earlier Phase I/II studies of Peru-15 indicated that a single dose was safe, immunogenic and protective.
¿ BioChem Pharma Inc., of Laval, Quebec, officially opened its $25 million product development center in Northborough, Mass. The facility will serve as BioChem's therapeutic product development center. BioChem develops vaccines against diseases and it best known for discovering 3TC/Epivir, a treatment for HIV/AIDS.
¿ Biokeys Pharmaceuticals Inc., of Houston, said it is trading under its new name and new stock symbol (Pink Sheets:BKYS). Biokeys is a result of the merger between the publicly traded BioQuest Inc. and privately held Biokeys Inc. Biokeys Pharmaceuticals Inc. will carry on the biopharmaceutical business and development efforts of both pre-merger companies.
¿ Cortex Pharmaceuticals Inc., of Irvine, Calif., and Les Laboratoires Servier, of Paris, entered three agreements. First, Servier will develop and commercialize Cortex's ampakine technology for the treatment of declines in cognitive performance associated with aging and neurodegenerative diseases. Second, the companies will jointly research and clinically develop new ampakines. Third, they will enroll patients in North America and Europe to determine efficacy of the ampakine CX516 compared to placebo in improving memory and cognition in mild cognitive impairment (MCI). Cortex will receive an up-front payment of $5 million and about $2 million per year for a minimum of three years in research support. Cortex will supply bulk CX516 for the cross national MCI trial, with both companies sharing clinical trial costs. Cortex will also receive potential milestones and royalties.
¿ D-Pharm Ltd., of Rehovot, Israel, completed a Phase I safety assessment for DP-b99, its novel neuroprotective under development as a first-line therapy to improve outcome in stroke and traumatic brain injury patients and as a prophylactic agent to protect against neurological complications associated with open-heart surgeries. The company is now initiating exploratory Phase II studies in Europe.
¿ Human Genome Sciences Inc., of Rockville, Md., said SmithKline Beecham Corp plc, of London, exercised its right to jointly develop and commercialize repifermin, or keratinocyte growth factor-2 (KGF-2), an HGS novel growth factor with potential indications for diabetic ulcers, pressure ulcers, oral and intestinal mucositis and inflammatory bowel disease. The compound recently provided positive Phase II trial results for venous ulcers, and HGS plans to move the compound forward to a large-scale safety and efficacy trial. The June 1996 agreement with SKB called for a 50/50 co-development and co-promotion option for SKB for HGS products that successfully complete a Phase IIa trail. Repifermin is the first such product from that collaboration. SKB and HGS will share equally in development costs at Phase III and beyond. KGF-2 entered the clinic in 1998. (See BioWorld Today, Feb. 10, 1998.)
¿ Lexicon Genetics Inc., of The Woodlands, Texas, filed suit for the second time against Deltagen Inc., of Menlo Park, Calif., for patent infringement related to U.S. Patent nos. 5,464,764; 5,487,992; 5,627,059 and 5,631,153, covering methods and vectors for using positive-negative selection to produce gene-targeting, or knockout, cells and animals. Lexicon filed suit against Deltagen earlier this year, claiming patent infringement upon its U.S. Patent No. 5,789,215, which covers the use of isogenic DNA technology.
¿ MacroChem Corp., of Lexington, Mass., signed an agreement with Pfizer Inc., of New York, under which Pfizer will evaluate the feasibility of using MacroChem's patented topical absorption enhancer, SEPA, to improve skin absorption of a group of Pfizer pharmaceuticals.
¿ MacroMed Inc., of Sandy, Utah, said the FDA completed a favorable review of the investigational new drug application for OncoGel, a novel formulation of paclitaxel utilizing ReGel, MacroMed's drug delivery system. MacroMed anticipates that OncoGel will be used in the treatment of cancer patients with problematic lesions or for those who are not candidates for aggressive surgical intervention.
¿ MGI Pharma Inc., of Hamburg, Germany, said interim results from a dose-escalating trial with irofulven, its anticancer compound, demonstrated enhanced safety and tolerance when administered using weekly dosing schedules. Prior Phase II efficacy trial results indicated antitumor activity in pancreatic, ovarian and prostate cancer.
¿ Molecumetics Ltd., of Seattle, and Athersys Inc., of Cleveland, agreed to collaborate on the development of small-molecule drug candidates. Athersys will use its RAGE-VT technology - random activation of gene expression for validated targets - to provide Molecumetics with 12 cell lines expressing validated targets of interest. Molecumetics will use its chemistry-based screen-to-IND technology platform to develop candidates against the targets. Molecumetics can access the targets by paying a license fee or through a co-development option. The co-development option allows the companies to co-invest in particular projects and share in the any value created.
¿ Morphochem AG, of Munich, Germany, said it achieved expansion of its Basel, Switzerland, operation ahead of schedule. By December, it said, recruitment of a 15-member team of anti-infective drug discovery and development scientists should be complete.
¿ National Institutes of Health scientists have succeeded in genetically engineering "Burkitt's mice," transgenic mice that exhibit Burkitt's lymphoma, a rare form of cancer caused by the accidental movement of the MYC gene from chromosome 8 to a new location, often chromosome 14. The MYC gene, which stimulates cell growth, is less strictly controlled when moved away from regulator genes on chromosome 8. The results of the work from the National Institute of Allergy and Infectious Diseases are detailed in the current issue of the Journal of Experimental Medicine.
¿ Orchid BioSciences Inc., of Princeton, N.J., said it canceled its secondary common stock offering, citing current market conditions as the reason. Last month, it filed to offer 3.5 million shares of common stock, including 1 million shares from stockholders.
¿ Oxford BioMedica plc, of Oxford, UK, received approval from the UK Gene Therapy Advisory Committee to enter Phase I/II clinical trials for its cancer vaccine, TroVax, in patients with colorectal cancer. The company plans to start the trials at the end of the year. TroVax is designed to stimulate the immune system to recognize and destroy cancer cells.
¿ Oxigene Inc., of Watertown, Mass., said researchers will present final results from Phase I clinical trials of Declopramide, an apoptosis inducer for use in conjunction with chemotherapy and radiation, at the 25th European Society for Medical Oncology Congress in Hamburg, Germany. Researchers say the compound demonstrated a promising safety profile. The company plans to initiate Phase II trials on the compound in the fourth quarter, using Declopramide in colon cancer patients as a second-line therapy.
¿ RHeoGene LLC, of Charlottesville, Va., received an Advanced Technology Program grant of $1.85 million from the National Institute of Standards to support development of next-generation "gene switches." The company said its ligand-induceable gene expression technology has potential to accelerate high-throughput drug discovery, functional genomics and proteomics.
¿ SangStat Medical Corp., of Fremont, Calif., implemented several changes in announcing a new strategy. It has terminated all clinical development programs for SangCya Oral Solution, CycloTech and diagnostic or monitoring products. It will reduce marketing expenses behind its cyclosporine products if the generic cyclosporine market becomes increasingly price-driven. Also, there may be additional overall expense control and a reduced head count in the areas not critical to the company's growth. It said the success of Thymoglobulin has provided the opportunity for the company to take advantage of markets beyond solid organ transplantation. The generic entrant and the increased use of other chronic immunosuppressants have reduced the overall potential of this market for SangStat. SangStat also will sell The Transplant Company, its mail-order pharmacy business. The changes will allow the company to focus clinical and marketing support on Thymoglobulin, ABX-CBL and RDP58 and give it the flexibility to take advantages of other collaboration opportunities in the broader therapeutic areas of inflammation, hematology and oncology. The company will change its name to SangStat Inc. and will phase out the logo, The Transplant Company. Jean-Jacques Bienaime was elected as the new chairman of the SangStat board of directors.
¿ Serono SA, of Geneva, Switzerland, and Bioject Medical Technologies, of Portland, Ore., expanded their exclusive licensing agreement covering Bioject's Vitajet needle-free injection system. The companies agreed in January to use Vitajet in the U.S. and Canada with Serono's recombinant human growth hormone for treatment of pediatric growth hormone deficiency, Saizen. That collaboration developed a customized version of the needless injection system, cool.click, that gained approval from the FDA in June.
¿ SignalGene Inc., of Montreal, signed a collaboration agreement with Universite Laval and the Centre Hospitalier Affile Universitaire de Quebec (CHA) for the identification of genetic risk factors involved in breast cancer. The agreement creates a partnership between SignalGene scientists and a research team at the CHA in Quebec City. SignalGene will apply the results of this research and its technology platform to the discovery and validation of new drug targets.
¿ Triad Therapeutics Inc., of San Diego, introduced Iope, its proprietary drug discovery platform guided by nuclear magnetic resonance spectroscopy, saying at the BioPartnering Europe Conference that proof of principal has been achieved for Iope seven months ahead of schedule. Iope, or integrated object-oriented pharmacoengineering, employs the technology of NMR spectroscopy to gather structural information on gene families and the proteins they encode.
¿ University of Pittsburgh Cancer Institute researchers reported interferon-alpha 2b improves overall and relapse-free survival in adults with surgically-treated melanoma considered at high risk of recurring in a study comparing interferon-alpha 2b with the anti-melanoma vaccine GMK, products from Schering-Plough Corp. and Progenics Inc., respectively. The study, distinguished as E1694 by the NCI, compared high doses of interferon-alpha 2b, 20MIU/m2 intravenously and 10MIU/mt subcutaneously, with the GMK vaccine.
¿ ViroPharma Inc., of Exton, Pa., intimated clinical trials of its antiviral compound for the treatment of respiratory syncytial virus disease, VP14637, in a trial designed to evaluate the compound's safety and pharmacokinetic profile in healthy volunteers. The small-molecule compound demonstrated high levels of potency and selectivity in laboratory studies through the inhibition of viral fusion protein in RSV.