Affymetrix Inc., of Santa Clara, Calif., said fixing errors in its Murine Genome U74 GeneChip arrays, and replacing those assays, will cost about $4 million. According to a filing with the Securities and Exchange Commission, the company's product suffered from errors in genetic sequence information from the UniGene U74 database it used in designing the Murine Genome U74 GeneChip arrays. Affymetrix uses gene sequence information in the public domain as a basis for its GeneChips. The company's shares (NASDAQ:AFFX) fell $5.125 Wednesday to close at $50.875, down 9 percent.
Arakis Ltd., of Cambridge, UK, and KS Biomedix Holdings plc, of London, entered a collaboration to develop new arthritis treatments. The collaboration will focus on AD 452, a performance-enhanced medicine developed by Arakis, and KSB306/7, a KS Biomedix compound. AD 452 is a single isomer cytokine modulator, and KSB306/7 is an anti-edemic cell redux modulator. Terms were undisclosed.
BresaGen Ltd., of Athens, Ga., and Adelaide, Australia, recruited the first patient in its Phase II study to investigate the effectiveness of its lead compound, E21R, in chronic myelomonocytic leukemia. The trial is being conducted at four sites in Australia.
Cell Genesys Inc., of Foster City, Calif., initiated a Phase I/II trial of GVAX, its cancer vaccine for multiple myeloma. The trial is designed to evaluate the safety and efficacy of the vaccine in combination with bone marrow transplantation in about 15 patients with multiple myeloma. GVAX is an immunotherapeutic comprised of irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor, an immunostimulant hormone.
Centocor Inc., of Malvern, Pa., developer of Remicade (infliximab), which was approved for treatment of Crohn's disease in 1998, found in research by the University of Medicine and Dentistry in New Jersey that infliximab could benefit patients with moderate to severe psoriasis. The university found that 80 percent of patients treated with infliximab achieved a good, excellent or clear rating. The 10-week, Phase II, double-blind, placebo-controlled, single-site trial evaluated 33 patients to determine response to the drug, which binds to the inflammatory modulator tumor necrosis factor.
Cerus Corp., of Concord, Calif., was awarded a $3.5 million cooperative agreement by the Army Medical Research Acquisition Activity division of the Department of Defense. The award is for developing Cerus' pathogen inactivation technologies to improve the safety and availability of blood that may be used by the U.S. Armed Forces for medical transfusions. Cerus will conduct research on the inactivation of infectious pathogens, and, in collaboration with investigators at Walter Reed Army Institute of Research, will investigate innovative ways to improve the storage and shelf life of blood and blood components. Cerus will receive commercial rights to any discoveries and inventions.
Chiron Corp., of Emeryville, Calif., granted a nonexclusive license for the research, development and commercialization of small-molecule therapeutics to Japan Tobacco Inc., of Tokyo, against a specified hepatitis C virus drug target contained in the HCV genome. The license allows Japan Tobacco to operate under certain Chiron patents to screen for drug candidates that inhibit HCV. Financial terms were not disclosed.
DNAPrint Genomics Inc., of Sarasota, Fla., entered a strategic agreement with a group of private physicians in Florida that provides it with blood specimens, biographical and biomedical baseline and endpoint data useful for the development of novel genomics-based diagnostic products. It will use the resources obtained to develop products that may enable physicians to match patients with the optimal course of chemotherapeutic treatment based on individual genetics.
Gene Logic Inc., of Gaithersburg, Md., will use a Staccato Applications-Focused Workstation, developed by Zymark Corp., of Hopkinton, Mass., for multigene screening as part of its effort to generate gene expression data. Financial details were not provided.
Helix BioMedix Inc., of New Orleans, reincorporated in the state of Delaware, effective Dec. 29, 2000, following shareholder approval. The company is developing lytic peptides as anti-infective, anticancer agents.
Hemispherx Biopharma Inc., of Philadelphia, began active screening of eligible patients for clinical studies with its investigational agent, Ampligen. To be eligible, patients must have experienced undetectable HIV for nine months or longer. The objective of the study is to encourage immune reconstitution with Ampligen while maintaining optimal antiviral effectiveness and minimizing potential toxicity of the patients' current antiviral regimens.
Heska Corp., of Fort Collins, Colo., obtained marketing rights from Genzyme Corp., of Cambridge, Mass., for a product for the detection of Giardia and Cryptosporidium. The agreement gives Heska the right to market the product for use in dogs and cats. Financial terms were undisclosed.
Icagen Inc., of Research Triangle Park, N.C., and Abbott Laboratories, of Abbott Park, Ill., extended their discovery and development collaboration for two years, expanding it to include the development of small-molecule drugs that target ion channels for the treatment of urological disorders such as incontinence, benign prostatic hypertrophy and sexual dysfunction. The companies entered the $12 million deal in December 1997, and the expansion included additional research funding for new therapeutic indications in urology. (See BioWorld Today, Dec. 9, 1997.)
Immtech International Inc., of Vernon Hills, Ill., completed a single-dose Phase I trial of DB289, its lead drug for treatment of Pneumocystis carinii pneumonia and African sleeping sickness. The company said it plans to advance the compound into a Phase II trial for African sleeping sickness, funded through a $15.1 million grant from the Bill and Melinda Gates Foundation, in the second half of the year. Results of the trial were unavailable.
Immusol Inc., of San Diego, said a study published in Antisense and Nucleic Acid Drug Development, Volume 10, proves the utility of its target validation technology using ribozyme gene delivery for inactivation of specific gene sequences. The study focused on two pro-inflammatory target genes, interleukin-1beta and interleukin-1beta converting enzyme.
Invitrogen Corp., of San Diego, said it reached an agreement to sell certain product lines, technologies and assets to Whatman plc, of the UK, and its Biometra division. The sales come as a result of a strategic review aimed at identifying noncore businesses and assets after the acquisition of Life Technologies Inc., of Rockville, Md. Whatman's purchase includes exclusive manufacturing and distribution rights to Invitrogen's human genetic and identity testing products. Further financial details were unavailable.
Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., will change its name to Genaera Corp., and begin trading Monday on Nasdaq under the ticker symbol "GENR."
Matrix Pharmaceuticals Inc., of Fremont, Calif., said the FDA accepted its new drug application filing for IntraDose (cisplatin/epinephrine) Injectable Gel for treatment of refractory or recurrent head and neck cancer. Matrix began submitting the NDA, offered in three tranches, in May 2000, and the company completed the NDA submission in January. (See BioWorld Today, May 23, 2000.)
Neoprobe Corp., of Dublin, Ohio, said researchers at the University of California, San Diego, received clearance from the FDA to begin clinical evaluation of a radiolabeled agent designed to assist in the diagnosis and surgical management of breast cancer patients. Enrollment of patients for the trial will begin shortly, the company said. Neoprobe has an option agreement to exclusively license the agent for diagnostic use.
Ortec International Inc., of New York, filed a premarket approval application with the FDA, requesting permission to market its composite cultured skin for the treatment of split-thickness donor sites in burn patients. Ortec received FDA approval under a humanitarian device exemption for hand reconstruction and for donor sites created in this procedure for victims of epidermolysis bullosa.
Pharmagene plc, of Royston, UK, signed a drug discovery agreement with Bayer Corp., a division of Bayer AG, of Leverkusen, Germany, in the area of oncology. Pharmagene will identify gene expression patterns across a matrix of diseased and nondiseased human tissue samples, constructed to depict nine cancer types of interest to Bayer for the purpose of characterizing novel therapeutic proteins and antibody targets. The agreement initially will cover a defined number of targets but will be expandable. Financial terms were not disclosed.
Raven Biotechnologies Inc., of San Carlos, Calif., spun out its CellArray technology into a private company, bioMosaic Systems Inc. The new company is commercializing a cell-based, high-throughput screening system by integrating cell biology, engineering and cryopreservation techniques.
RxKinetix Inc., of Louisville, Colo., and Elan Corp. plc, of Dublin, Ireland, said their joint venture's first investigational new drug application to the FDA has been reviewed without comment, enabling the venture to begin a planned Phase Ib trial in the near future. The IND for a compound to treat oral mucositis due to chemotherapy or radiation treatment, RK-0202, was developed using RxKinetix's ProGelz polymer drug delivery system.
Sangamo BioSciences Inc., of Richmond, Calif., obtained exclusive worldwide rights to a novel cell-based molecular screening system developed by the Massachusetts Institute of Technology. The license includes exclusive worldwide rights to patent applications covering the selection and identification of sequence-specific DNA-binding proteins in bacterial cells.
Select Therapeutics Inc., of Woburn, Mass., said Tulane University's Center for Gene Therapy, whose research into the use of stem cells for treatment of genetic bone disease Select licenses, opened in a 14,000-square-foot facility in downtown New Orleans. The grand opening included disclosure of positive results of a study in stem cell therapy for treatment of osteogenesis imperfecta. That study was based on discoveries by center Director Darwin Prockop, and focused on the use of mesenchymal stem cells, non-blood-producing stem cells, in five young patients with the brittle bone disease.
Vyteris Inc., of Fair Lawn, N.J., was formed through the acquisition of Becton Dickinson and Co., of Franklin Lakes, N.J., by Spencer Trask Specialty Group LLC, of New York. The deal was struck in November and disclosed publicly Wednesday. The company is privately held and initially will focus on iontophoresis, the process of delivering drugs transdermally using an active transport mechanism.
Zonagen Inc., of The Woodlands, Texas, said a paper reviewing its product, Vasomax, was published in the February issue of the World Journal of Urology. The paper provides an overview concerning phentolamine mesylate, the active ingredient in Vasomax, and also summarizes the efficacy and safety data gathered on the oral therapy for the treatment of erectile dysfunction. The drug is on partial clinical hold in the United States pending the outcome of a mechanistic rodent study started in the fourth quarter of 2000.