3M Drug Delivery Systems Division, of St. Paul, Minn., entered into an agreement with Novartis Pharma AG, of Basel, Switzerland, to explore future development and manufacturing opportunities for a range of new Novartis inhalation products. The deal is aimed at developing Novartis’ pipeline of inhalation products that will be delivered via metered dose inhalers. Further details were not disclosed.
Accelrys Inc., of San Diego, released Catalyst 4.7, a lead identification and optimization application for speeding up preclinical pharmaceutical research. Catalyst 4.7 supports Linux and IBM AIX platforms and adds increased database scalability and pharmacophore modeling functionality, it said.
Axiom Biotechnologies Inc., of San Diego, entered a collaboration with Sosei Co. Ltd., of Tokyo, to use its physiogenomics technology to identify new indications for drug candidates from Sosei’s drug reprofiling platform collection. Sosei has assembled a library of drug candidates that have demonstrated acceptable safety profiles in clinical trials. Axiom will profile those compounds for clinically relevant activities using its physiogenomics approach, which produces high-definition data on compound function in a broad array of human cell types. The collaboration’s length is two years, but it can be extended by mutual consent. Financial terms were not disclosed.
Cel-Sci Corp., of Vienna, Va., said all eight head and neck cancer patients in a Phase II trial who were treated by one investigator in Hungary with Cel-Sci’s immunotherapy drug, Multikine, in combination with surgery and radiation more than two years ago have not had recurrences to date and remain alive. It is generally expected that approximately 50 percent of such patients would have experienced recurrences 18 to 24 months after treatment, a recurrence that usually leads to death. Cel-Sci plans to gather the same information from other investigators as well.
Corixa Corp., of Seattle, and Rhein Biotech NV, of Maastricht, the Netherlands, entered a license and supply agreement in which Rhein acquired from Corixa the co-exclusive worldwide commercial rights to Corixa’s RC-529 synthetic adjuvant for use in Rhein’s two-dose hepatitis B vaccine and therapeutic hepatitis B vaccine development program. Corixa will receive up-front license fees, milestone payments and royalties on future product sales. Corixa will produce and supply RC-529, and Rhein will be responsible for commercialization of the new hepatitis B vaccine candidates. Financial details were not disclosed.
DeCode Genetics Inc., of Reykjavik, Iceland, said the Icelandic government intends to introduce in parliament this week a bill that would enable the government to guarantee a convertible bond offering by DeCode, a measure intended to promote private sector investment in new components of DeCode’s drug development program. The bill, if approved, would authorize the minister of finance to guarantee an offering of up to $200 million in convertible bonds. It is contemplated that any such bonds should be convertible into DeCode shares at about $18 per share, the stock price issued in DeCode’s July 2000 IPO.
Deltagen Inc., of Redwood City, Calif., delivered the seventh quarterly release of DeltaBase, containing functional information about 437 genes and their in vivo mammalian roles to its pharmaceutical customers. Of the genomic drug targets previously delivered to DeltaBase, customers have accessed 15 percent of the knockout models for further research. In developing DeltaBase, Deltagen uses bioinformatics approaches to select genes from gene families that have been successfully targeted using today’s chemistries.
Genzyme Molecular Oncology, of Framingham, Mass., a division of Genzyme Corp., enrolled 36 patients in its Phase I/II gene therapy cancer vaccine clinical trial for melanoma. The company plans to expand the trial protocol due to interest among investigators and eligible patients. The in vivo gene therapy vaccine combines MelanA/MART1 and gp100 into a vaccine that uses an adenovirus vector to deliver the antigens intradermally.
Guilford Pharmaceuticals Inc., of Baltimore, presented at the annual meeting of the European Society of Anesthesiology in Nice, France, Phase I data for Aquavan Injection that suggested it can induce sedation and anesthesia without causing serious side effects. The study demonstrated that although comparable plasma concentrations of propofol were achieved in two groups, there was a greater decrease in the median EEG frequency for propofol from Aquavan Injection, EC50 2 micrograms/ml, than with Diprivan Injectable Emulsion EC50 3 micrograms/ml (p<0.05).
Lawrence Berkeley National Laboratory, of Berkeley, Calif., released a pair of new programs. Its VISTA (Visualization Tool for Alignments) program depicts long sequence alignments of DNA from two or more organisms. AVID is an alignment program designed to work with VISTA by globally aligning DNA sequences for annotation and biological discovery.
MitoKor Inc., of San Diego, reported publication of a large, wide-ranging study analyzing the mitochondrial DNA sequences of more than 500 individuals of different ethnic origins, in The American Journal of Human Genetics. MitoKor said the study succeeded in identifying novel patterns arising from geographically distinct subpopulations, and will form the basis of ongoing investigations aimed at uncovering the association of variations in mitochondrial DNA with diseases of aging such as Alzheimer’s and Type II diabetes.
Neurochem Inc., of Saint-Laurent, Quebec, presented preclinical studies showing promising dual anticonvulsant and anti-epileptogenic activity profiles for a series of compounds under development for the prevention and treatment of seizures and convulsions associated with epilepsy, as well as preventing the development of epilepsy following head trauma or acute brain injury. The presentation was made at the Sixth Eilat Conference on Neuro Anti-Epileptic Drugs in Sicily, Italy. Neurochem focuses on dual action compounds to treat epilepsy.
Nobex Corp., of Research Triangle Park, N.C., and Elan Corp. plc, of Dublin, Ireland, said their joint venture, Synerobex, began dosing in a Phase I trial for Oratonin, oral calcitonin, for the treatment of osteoporosis. The randomized, single-blind, placebo-controlled, dose-escalation study will explore the tolerance, safety and absorption of Oratonin in healthy volunteers. The trial is the first exposure of Nobex modified oral calcitonin in humans.
ProdiGene Inc., of College Station, Texas, said it successfully expressed a subunit vaccine in maize that is expected to produce an immune response to simian immunodeficiency virus (SIV), the primate equivalent to HIV. The research, funded by an innovation grant program from the NIH Institute of Allergy and Infectious Disease’s Office of AIDS Research, is designed to develop a source of SIV gp120 protein, as well as to establish a potential oral delivery system for an AIDS vaccine.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., began two additional studies within the Phase III program of Axokine for the treatment of obesity. The randomized, double-blind, U.S.-based trials are designed to study long-term maintenance of weight loss following shorter-term treatment regimens. Participants in the first study will be given Axokine or placebo for six months and will then be observed for six more months off treatment. The companion study will treat subjects with Axokine or placebo for three months and observe them for an additional nine months. The 300-patient trials will run concurrently. (See BioWorld Today, Aug. 1, 2001.)
Synthematix Inc., of Research Triangle Park, N.C., entered a collaboration with Inspire Pharmaceuticals Inc., of Durham, N.C., to provide Synthematix’s new chem-informatics software for storing and searching databases of useful chemical procedures. Inspire will contribute useful synthetic procedures to Synthematix’s Arthur database and also will be able to access the system for detailed chemical, reagent, equipment and procedural information. Financial details were not disclosed.
Texas Biotechnology Corp., of Houston, and GlaxoSmithKline plc, of London, said the FDA approved the supplemental new drug application for the new use of Argatroban as an anticoagulant in patients with, or at risk for, heparin-induced thrombocytopenia (HIT) undergoing percutaneous coronary interventions. Argatroban already was approved for the prophylaxis or treatment of thrombosis in patients with HIT. Argatroban, co-developed by Texas Biotechnology and GlaxoSmithKline, is marketed in the U.S. by GlaxoSmithKline. (See BioWorld Today, July 3, 2000.)
Tm Bioscience Corp., of Toronto, and MetriGenix Inc., of Gaithersburg, Md., entered a nonexclusive licensing agreement that grants MetriGenix access to Tm’s Universal Array technology, including both the Tm100 and Tm1000, for use on MetriGenix’s 4D Assay System. MetriGenix will provide Tm with royalty payments on the sales of Universal Array-based products.
Transgene SA, of Strasbourg, France, began a Phase II trial of its immunotherapeutic MVA-Muc1-IL2 vaccine candidate for the treatment of prostate cancer. The study will evaluate the efficacy of subcutaneous injections of MVA-Muc1-IL2 as a single agent administered to patients with prostate cancer distributed randomly in two groups on different dosing schedules. The U.S. trial will include up to 50 patients with prostate cancer who have progressive elevation of their PSA level, without documented evidence of metastatic disease after having undergone primary therapy.
XOMA Ltd., of Berkeley, Calif., began enrollment in a Phase II trial that will evaluate Xanelim (efalizumab) in patients with moderate to severe rheumatoid arthritis. The multicenter, randomized, double-blind, placebo-controlled trial is planned to enroll approximately 240 patients. The patients will be treated concurrently with methotrexate, and will receive weekly subcutaneous injections of Xanelim or placebo. The study is designed to evaluate the safety and efficacy of Xanelim in patients with moderate to severe disease. The primary endpoint, a reduction in the signs and symptoms of the disease in patients with active moderate to severe rheumatoid arthritis, will be measured after 24 weeks.