¿ Advion BioSciences Inc., of Ithaca, N.Y., opened a new European subsidiary based in Norfolk, UK, and appointed Mark Allen vice president of European operations. Allen will be responsible for business development to support market introduction in the second quarter of 2002 of its new ESI Chip, designed to enhance the performance of mass spectrometry in proteomics, drug discovery and drug development.
¿ AEterna Laboratories Inc., of Quebec City, Quebec, completed patient recruitment for its Phase III Neovastat trial in renal cell carcinoma. About 280 patients will participate in the trial at 50 centers in 10 countries. The study will seek to determine whether Neovastat can increase survival time in patients who have failed to respond to standard immunotherapy treatments. Results are expected in early 2003.
¿ Antex Biologics Inc., of Gaithersburg, Md., began a Phase I trial for the second component of its combination Activax vaccine to prevent travelers¿ diseases caused by the consumption of contaminated food and water. The trial is designed to test the safety and immunogenicity of a vaccine against Shigella sonnei infection, for which there are no existing vaccines. The vaccine was developed using the company¿s nutriment signal transduction technology. The trial is scheduled for completion in late 2002 or early 2003.
¿ AVAX Technologies Inc., of Kansas City, Mo., said it submitted its response to the FDA¿s warning letter. The company said the policies and procedures implemented, combined with the change to a frozen vaccine product, will fully address the FDA¿s concerns, allowing AVAX to produce, distribute and administer the vaccine in compliance with regulatory requirements.
¿ BioFocus plc, of Cambridge, UK, entered a research agreement with GlaxoSmithKline plc, of London, for the development of new drug leads to treat asthma and chronic obstructive pulmonary disease. GSK will provide BioFocus with details of hit molecules identified from a screening program. BioFocus will optimize the molecules. Financial details were not provided.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., presented positive results of its calcium phosphate (CAP) delivery system at the sixth U.S.-Japan Symposium on Drug Delivery in Hawaii. The preclinical trial evaluated the use of BioSante¿s CAP drug delivery system to administer therapeutic drugs orally and showed that, when administered into the stomach, the system reduced the blood glucose levels by 80 percent within the first hour of treatment. The reduced glucose levels were maintained throughout the 12-hour blood-sampling period.
¿ Cangene Corp., of Winnipeg, Ontario, said it filed a new drug submission for its anti-hepatitis B hyperimmune in Canada. The submission follows a U.S. licensing application filed earlier this year and seeks Health Canada approval for use in treating individuals exposed to hepatitis B. Cangene plans a filing for Europe and is investigating new indications for the drug.
¿ Exelixis Inc., of South San Francisco, and the Institute of Molecular and Cellular Biology in Strasbourg, France, identified several genes involved in immunity with roles previously uncharacterized. The scientists conducting this research said further study of these genes and their role in the immune response could lead to the development of new treatments for inflammatory diseases, such as asthma and rheumatoid arthritis. The findings are published in the Dec. 18 issue of The Proceedings of the National Academy of Sciences.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, reported results of an in vitro study using nitric oxide donors to decrease resistance of cancer cells to chemotherapeutic drugs. The results are being published in the Journal of the National Cancer Institute, Vol. 93, 2001. Charles Graham, a consultant to Cellegy, reported that cancer cells made resistant to chemotherapeutic agents by causing them to become hypoxic following incubation with the nitric oxide synthase inhibitor N-monomethyl l-arginine could be made susceptible to these drugs again if the cells were exposed to nitroglycerin, a nitric oxide donor. The study raises the possibility that nitric oxide donors may be used as adjuvants to increase the potency of chemotherapeutic agents.
¿ Cellomics Inc., of Pittsburgh, and Norak Biosciences Inc., of Research Triangle Park, N.C., signed a cross-license agreement granting Norak nonexclusive rights to Cellomics¿ intellectual property for high-content screening (HCS) for its internal use and for the commercialization of Transfluor for use on HCS platforms in drug discovery. Norak grants Cellomics nonexclusive rights to its intellectual property for Transfluor to facilitate the development and commercialization of software that can analyze Transfluor on any Cellomics HCS platform. Cellomics has developed a software application for the measurement, analysis and reporting of receptor activation that includes the ability to analyze Transfluor. The companies will promote Transfluor on ArrayScan and KineticScan HCS platforms. Financial terms were not disclosed.
¿ Fred Hutchinson Cancer Research Center, of Seattle, researchers have discovered a chemical compound that reverses a process called silencing, in which genes or chromosomal regions are shut off. The findings are published in the Dec. 18 edition of the Proceedings of the National Academy of Sciences. Such inhibitors of gene silencing could have applications for treating a variety of malignancies, including acute myelogenous leukemia, colon cancer and certain forms of breast cancer, all of which have genetic abnormalities that lead to inappropriate silencing of genes that are critical for healthy growth, the center said.
¿ GeneFormatics Inc., of San Diego, and IBM Corp., of Armonk, N.Y., entered an agreement they said could pave the way for more efficient drug discovery. IBM becomes GeneFormatics¿ preferred information technology and services partner. IBM will provide a range of hardware and software products and services to support GeneFormatics¿ work in rapidly discovering the functions and structures of thousands of proteins, including hundreds of human proteins that may be associated with various diseases. IBM also is participating in GeneFormatics¿ third round of equity financing.
¿ Genentech Inc., of South San Francisco, and Celltech Group plc, of Slough, UK, reached a settlement in the matter of the U.S. Patent Office interference involving Celltech¿s ¿Boss¿ patent application and Genentech¿s ¿Cabilly¿ patent application, both of which relate to manufacturing technology. The settlement comes into effect following the recent granting of the Cabilly patent by the Patent Office and an order of the court to revoke and withdraw the Boss patent, and grant and issue the Cabilly patent. Celltech will be compensated by Genentech in terms of income from sales of products that would otherwise have been covered by the Boss patent until its normal expiration date in 2006. Celltech also secured rights to Genentech¿s Cabilly patent for its products, Celltech said.
¿ Genicon Sciences Corp., of San Diego, and BD Biosciences Clontech, part of Becton, Dickinson and Co., of Franklin Lakes, N.J., signed an agreement to design resonance light scattering signal generation and detection technology for use with BD Biosciences Clontech¿s line of BD Atlas Microarrays. They hope to provide scientists with a means to detect differential gene expression as compared to commonly used fluorescent-based detection methods.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., said its stockholders voted in favor of the acquisition of Cartesian Technologies Inc., of Irvine, Calif. The acquisition extends Genomic Solutions¿ capabilities into high-throughput screening and provides for further DNA analysis and drug discovery solutions. (See BioWorld Today, Sept. 10, 2001.)
¿ Graffinity Pharmaceutical Design GmbH, of Heidelberg, Germany, and Structural GenomiX, of San Diego, entered a collaboration aimed at creating an approach for more rapid lead discovery. Graffinity will screen several targets, supplied by SGX, with its library of small molecular fragments. Based on the resultant chemo-biological information, Graffinity will synthesize selected fragments. SGX will then co-crystallize a combination of selected fragments with the targets and provide precise images of the interaction topology and binding modes. Through Graffinity¿s Rapid Array Informed Structure Evolution Process, the small organic molecules can be further directed by their interactions with proteins. Structural data achieved through this collaboration will be used to advance both companies¿ lead generation efforts.
¿ Martek Biosciences Corp., of Columbia, Md., privately placed about 1.2 million newly issued shares of Martek stock with new and existing investors. The shares were priced at $19.25, grossing about $22.5 million. Adams, Harkness & Hill served as placement agent for the transaction. Martek develops, manufactures and sells products from microalgae. Its products include nutritional supplements, specialty nutritional oils for infant formula and fluorescent markers for diagnostics, rapid miniaturized screening and gene and protein detection.
¿ Interneuron Pharmaceuticals Inc., of Lexington, Mass., said Pfizer Inc., of New York, reported that patients treated with pagoclone experienced a statistically significant improvement in symptoms of generalized anxiety disorder, compared to patients receiving placebo. Also, pagoclone was well tolerated, with no difference from placebo in sedation and no evidence of withdrawal effects. The six-week trial involved 200 patients. Pfizer is conducting a number of clinical trials, including a Phase III trial in panic disorder, multiple Phase II trials in GAD and multiple pharmacology studies. Pfizer is now analyzing data from a Phase III trial in panic disorder. Pagoclone is a gamma amino butyric acid receptor agonist. Interneuron licensed pagoclone from Rhone-Poulenc Rorer SA, now Aventis SA, of Frankfurt, Germany, and then licensed worldwide rights to Warner-Lambert Co., now Pfizer.
¿ Introgen Therapeutics Inc., of Austin, Texas, said INGN 241, its mda-7 gene drug candidate, in combination with Herceptin, demonstrated supra-additive effects of the gene therapy in breast cancer. The company presented preclinical results at the 10th International Conference on Gene Therapy of Cancer, held in San Diego. INGN 241 and Herceptin was evaluated in a series of breast cell cancer lines. Separately, the company presented results of preclinical studies evaluating the potential of its p53 gene therapeutic, INGN 201, as an anticancer vaccine. In the preclinical studies, mice injected with dendritic cells expressing mouse p53 were protected against the development of tumors.
¿ Invitrogen Corp., of San Diego, said it will join the Nasdaq-100 Index effective at market open Dec. 24. Shares of IVGN also will be included in the Nasdaq-100 Trust. The Nasdaq-100 Index represents 100 of the largest financial companies listed on the national market tier of the Nasdaq stock market based on market capitalization. Other companies to be added to the Nasdaq-100 include ImClone Systems Inc., of New York; Sepracor Inc., of Marlborough, Mass.; Cephalon Inc., of West Chester, Pa.; ICOS Corp., of Bothell, Wash.; and Protein Design Labs Inc., of Fremont, Calif.
¿ Maxim Pharmaceuticals Inc., of San Diego, reported that clinical investigators are treating patients in a Phase II trial of Ceplene (histamine dihydrochloride) in triple-drug combination therapy for patients with hepatitis C who failed to respond to prior therapy. The randomized, controlled study is designed to compare the treatment with a triple-drug combination of Ceplene, Peg-Intron and Rebetol (ribavirin) vs. Peg-Intron and Rebetol combination therapy alone. The study will include up to 282 patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin.
¿ Meditech Research Ltd., of Australia, said its Phase I trial with its colon cancer product, HyFIVE, was successfully completed with patients reporting no drug-related adverse effects to date. The data are being analyzed and will be ready for presentation in the first quarter of 2002. Meditech is planning Phase II trials.
¿ Neurocrine Biosciences Inc., of San Diego, received a Phase I Small Business Technology Transfer grant from the National Institutes of Health to develop a treatment for narcolepsy. The grant will help fund research in a collaborative effort between Neurocrine and the laboratory of Emmanuel Mignot, director of the center for narcolepsy at Stanford University School of Medicine/Sleep Research Center. Neurocrine said Mignot and his colleagues were the first to discover the link between the hypocretin system and narcolepsy. The development of an orally active, small-molecule agonist to the hypocretin-2 receptor may provide a therapy for patients with narcolepsy, Neurocrine said.
¿ Novogen Ltd., of Sydney, Australia, said it is ready to begin the fifth human trial of its anticancer compound, phenoxodiol. An oral form will be administered to leukemia patients in a Phase Ib/IIa trial to be conducted at the Royal North Shore Hospital in Sydney. Phenoxodiol is a small molecular signal transduction inhibitor that is designed to target abnormal signaling processes in cells.
¿ Pharmacopeia Inc., of Princeton, N.J., and Locomogene Inc., of Tokyo, entered a research collaboration in the osteoarthritis/rheumatoid arthritis area. Pharmacopeia will provide assay development expertise, a compound sample collection and ultra-high-throughput screening technology to identify lead compounds for a Locomogene target. Pharmacopeia will receive funding and will be entitled to receive milestones and royalties on any approved drugs. Further financial details were not provided.
¿ Synaptic Pharmaceutical Corp., of Paramus, N.J., filed its first investigational new drug application with the FDA to begin trials with a drug to treat depression. The drug acts through SCT-11, a novel G protein-coupled receptor discovered at Synaptic. The company said the drug has proven to be effective in multiple animal models and neurochemical assays that are predictive of antidepressant activity in humans.
¿ Telik Inc., of South San Francisco, filed an investigational new drug application to initiate clinical development of its product candidate, TLK199. Telik intends to initiate a Phase I/IIa trial in patients with myelodysplastic syndrome, a bone marrow disorder. TLK199 is a small molecule that inhibits the activity of the enzyme glutathione S-transferase.
¿ Transgene SA, of Strasbourg, France, initiated a Phase II trial of its immunotherapeutic MVA-HPV-IL2 vaccine candidate for the treatment of vulvar intra-epithelial neoplasia. The trial will be conducted in France and will involve up to 30 affected women. The trial will be placebo controlled with a primary objective of demonstrating clinical efficacy as measured by the elimination of lesions in at least half of the treated patients at six months.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., completed its follow-on public offering, raising a total of about $125.6 million. About 3.2 million shares were sold at $39 per share, including 420,000 shares to cover overallotments. The joint bookrunning managers for the offering were SG Cowen Securities Corp. and Deutsche Banc Alex. Brown. Co-managers were Pacific Growth Equities Inc. and Leerink Swann & Co. (See BioWorld Today, Dec. 14, 2001.)
¿ Vical Inc., of San Diego, said it entered an exclusive, worldwide license agreement with CytRx Corp., of Atlanta, granting Vical rights to use or sublicense CytRx¿s TranzFect poloxamer technology to enhance viral or nonviral delivery of polynucleotides in all preventive and therapeutic human and animal health applications, excepting four infectious disease vaccine targets already licensed to Merck & Co. Inc., of Whitehouse Station, N.J., and prostate-specific membrane antigen. Vical will make an up-front payment and CytRx will have the opportunity for milestones and royalties on approved products.
¿ Xenerex Biosciences, a subsidiary of Avanir Pharmaceuticals Inc., of San Diego, said it successfully generated antibodies to the first two cancer-target antigens provided by Eos Biotechnology Inc., of South San Francisco, through the parties¿ research collaboration that began in May. Eos has asked Xenerex to proceed to the next stage of the agreement, which will provide Eos with more information on selected panels of the antibodies that meet the antibody characteristics defined in the agreement.