AltaRex Corp., of Waltham, Mass., commenced its OvaRex human pharmacokinetic study with the treatment of the first three patients. AltaRex intends to enroll 24 patients in the trial. The pharmacokinetic study is a final step in establishing the equivalency of the new OvaRex manufacturing procedure with the old process used to generate antibody for the company’s clinical trials. The study is expected to be complete in the second quarter of this year.
Alteon Inc., of Ramsey, N.J., said findings from a preclinical study of two of its drugs support the ongoing development of a treatment for the critically ill population of end-stage renal disease patients undergoing peritoneal dialysis. At the 22nd Annual Conference on Peritoneal Dialysis, being held in conjunction with the Annual Conference of Dialysis in Tampa, Fla., researchers presented findings that demonstrated beneficial effects of the A.G.E. Crosslink Breaker ALT-711 and the A.G.E. Inhibitor pimagedine on the structure and function of the peritoneum in a rat peritoneal infusion model. ALT-711, Alteon’s lead A.G.E. Crosslink Breaker, is in a Phase I study.
AtheroGenics Inc., of Atlanta, began a Phase I trial of AGI-1096 as an oral treatment for the prevention of organ transplant rejection. AGI-1096 is an antioxidant and selective anti-inflammatory agent derived from AtheroGenics’ v-protectant technology platform. The study is being conducted in the U.S. and will assess the product in healthy volunteers.
AVI BioPharma Inc., of Portland, Ore., said it will extend, by three months each, the expiration dates of its warrants trading under the symbols AVIIW and AVIIZ. With the extension, AVIIW warrants will now expire on Sept. 3, 2002, and AVIIZ warrants will expire on Aug. 15, 2003. The AVIIW warrants originated in AVI’s initial public offering in 1997, and the AVIIZ warrants were part of the consideration in AVI’s purchase of ImmunoTherapy Corp. in 1998. The exercise price for each of the warrants remains unchanged at $13.50 per warrant for one share of common stock.
Ciphergen Biosystems Inc., of Fremont, Calif., and Beckman Coulter Inc., of Fullerton, Calif., formed an alliance to automate clinical proteomics research by combining Ciphergen’s biomarker discovery and assay platform with a version of Beckman Coulter’s Biomek 2000 system. Optimized for use with the ProteinChip Biomarker System, the new solution will be offered through Ciphergen. Financial details were not disclosed.
Crucell NV, of Leiden, the Netherlands, said initial data from a Phase I trial involving an experimental HIV vaccine developed by Merck & Co. Inc., of Whitehouse Station, N.J., look encouraging. The HIV vaccine, based on a recombinant adenovirus, is produced on Crucell’s PER.C6 cell technology platform. The data, presented at the ninth Conference on Retroviruses and Opportunistic Infections in Seattle, show that the vaccine for both the prevention and treatment of HIV was generally well tolerated by the healthy volunteers enrolled in the study and generated a substantial and prolonged specific T-cell response. Crucell and Merck signed an agreement in October 2000, granting Merck an exclusive commercial license to the PER.C6 platform to develop the vaccine.
DepoMed Inc., of Menlo Park, Calif., completed enrollment in its Phase II clinical trial of Ciprofloxacin GR. The indication is urinary tract infection. The study compares the company’s once-daily extended-release dosage form, Ciprofloxacin GR, with the immediate-release ciprofloxacin HCl formulation, Cipro. Cipro is a registered trademark of Bayer AG. DepoMed’s Gastric Retention System is an oral drug delivery technology designed for drugs preferentially absorbed high in the gastrointestinal tract.
Fujirebio Diagnostics Inc., of Malvern, Pa., and Yale University are in an agreement under which Fujirebio acquired the rights to develop and commercialize cancer diagnostic tests based on the cancer-specific gene Survivin. The agreement also includes diagnostic rights for therapeutic drug monitoring. Fujirebio will provide Yale with license fees, milestone payments and royalties. The Survivin gene was chosen because of its specific expression in tumor tissues.
Galapagos Genomics NV, of Mechelen, Belgium, completed a EUR21.4 million (US$18.6 million) private placement. The financing was co-led by UK-based Abingworth Management; Apax Partners, of France; and Burrill & Company, of the U.S. Other investors in the round include NIB Capital and Crucell Holland BV, both of the Netherlands. Galapagos was established in 1999 as a joint venture between Crucell NV, of Leiden, the Netherlands, and Tibotec-Virco, of Belgium. Galapagos is focused on target identification and validation using its adenoviral-based PhenoSelect platform.
Immunomedics Inc., of Morris Plains, N.J., said its board approved the redemption of all outstanding rights under its 1998 stockholders rights plan in connection with the adoption of a new 2002 plan. The 2002 plan is not being adopted in response to any specific effort to acquire control of the company, Immunomedics said.
Incyte Genomics Inc., of Palo Alto, Calif., signed a lease agreement with DuPont Pharmaceuticals, of Wilmington, Del., to locate a biotechnology research operation in the Stine-Haskell Research Center in Newark, Del. Incyte plans to move into the space this month. Incyte initially will lease up to 50,000 square feet of the center.
Ionix Pharmaceuticals Ltd., of Cambridge, UK, signed an agreement with Xenome Ltd., of Brisbane, Australia, to collaborate on the design, synthesis and screening of toxins and derivatives for evaluation as potential inhibitors of Ionix drug targets. The collaboration includes the search for selective antagonists of a sodium channel drug target that is expressed in the PNS. Xenome has synthesized libraries of toxin peptides, based on native toxin peptide structures isolated from a variety of venomous species. Ionix will screen these libraries against a number of ion channel drug targets to identify hit compounds that will allow the construction and modeling of novel pharmacophores for these targets. The companies also will collaborate on the use of their computational chemistry, medicinal chemistry and pharmacology resources to design and evaluate lead series of both peptide and nonpeptide drugs arising from their research. Financial details were not disclosed.
Ixion Biotechnology Inc., of Alachua, Fla., said it received a six-month, $99,000 Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md., to test a process that could trans-differentiate human bone marrow stem cells and mesenchymal stem cells into insulin-producing islets. The SBIR Phase I study will characterize human bone marrow for the expression of developmental genes involved in the generation of islets following treatments with various factors in vitro, and will determine the functional capability of the differentiated cells, the company said.
LumiCyte Inc., of Fremont, Calif., said it is moving forward with clinical trials at several medical centers to evaluate its protein biomarker profiles for the early detection of various cancers. The biomarkers were discovered using LumiCyte’s rights to the SELDI (Surface-Enhanced Laser Desorption/Ionization) technology. LumiCyte’s services are based on its advanced SELDI biochips, its data analysis tools and the BioPhore Knowledgebase, which includes LumiCyte’s large human serum protein database.
Miravant Medical Technologies Inc., of Santa Barbara, Calif., following a Phase III study setback, said it terminated certain contractual relationships with Pharmacia Corp., of Peapack, N.J., including the ophthalmology development and license agreement and other related contracts for the drug SnET2. Miravant regained the rights to assets related to the SnET2 Phase III trials for age-related macular degeneration, including the clinical data package. Also, Miravant restructured the credit agreement in which Pharmacia reduced the outstanding debt from approximately $27 million to $10 million. Miravant will re-assume lease obligations for the SnET2 manufacturing facility and will forego the remaining $3.2 million line of credit. The SnET2 assets returned to Miravant include the investigational new drug application, preclinical and clinical data, inventories of active pharmaceutical ingredient and finished-dose formulation, drug manufacturing rights, manufacturing equipment and clinical laser devices. In January, Miravant suffered a 75.6 percent stock drop on negative Phase III data of SnET2. Its stock (NASDAQ:MRVT) fell $7.31 on the day the news was released, closing at $2.44. Miravant’s stock rose 44 cents Tuesday, or 55 percent, to close at $1.24. (See BioWorld Today, Jan. 15, 2002.)
Nabi, of Boca Raton, Fla., changed its name to Nabi Biopharmaceuticals. It said the change recognizes the completion of the company’s transition to a vertically integrated biopharmaceutical company. Its focus is on the development and commercialization of vaccines and antibody-based therapies to treat and prevent infectious, autoimmune and addictive diseases.
Neurosearch A/S, of Ballerup, Denmark, said additional preclinical safety studies on NS2389 meant to determine the mechanism of cell changes after long-term treatment with high doses of the substance did not provide desired results. Phase II studies with the product were performed in 1999 and 2000. The NS2389 program was suspended in August 2000 following completion of a preclinical safety study showing some cell changes in animals after long-term treatment with high doses of the substance. Development of NS2389 is being discontinued. In February 2000, Neurosearch and GlaxoSmithKline plc, of London, signed a development and license agreement granting GlaxoSmithKline worldwide rights to NS2389 and several other patented Neurosearch substances.
Northwest Biotherapeutics Inc., of Bothell, Wash., said it will present favorable results from the Phase I/II late-stage prostate cancer clinical evaluation of its dendritic cell-based immunotherapy, DCVax-Prostate, at the Fourth Walker’s Cay Colloquium on Cancer Vaccines and Immunology sponsored by the Albert B. Sabin Vaccine Institute. The Colloquium will take place today through Sunday. The data are from 29 late-stage prostate cancer patients with no other treatment alternatives who received DCVax-Prostate during a Phase I/II trial. Northwest Biotherapeutics observed overall stabilization of disease in 55 percent (16 of 29) of the patients in its Phase I/II trial. Ten of the patients with rising PSA values following hormone therapy did not have measurable metastatic disease at the time of treatment initiation. All 10 were stable at the conclusion of the trial as measured by radiographic criteria at weeks 23 and 28.
Nymox Pharmaceutical Corp., of Maywood, N.J., said one of its leading Alzheimer’s disease drug candidates, NXD 9062, works in animals by stopping cell damage similar to damage seen in Alzheimer’s disease. The drug candidate has been well tolerated and shown to limit the damage. Nymox plans to target the compound for human testing this year.
Orchid Biosciences Inc., of Princeton, N.J., and First Genetic Trust Inc., of Deerfield, Ill., formed an alliance to develop and market a range of pharmacogenetic services to pharmaceutical and biotechnology companies, academic research centers and health care providers. First Genetic Trust will provide its genomic data banking services, clinical trial management capabilities and collaborative patient registries to the alliance, while Orchid offers high-throughput genotyping services and associated analytic and data support. Orchid and First Genetic will collaborate to develop and market a variety of services.
Protherics plc, of London, said DigiFab, a treatment for digoxin toxicity, was launched in the U.S. The product is marketed by Savage Laboratories, a division of Altana Inc., of Melville, N.Y. DigiFab is made of specific antibody fragments that bind to and neutralize digoxin molecules.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported positive preliminary data from its Phase III trial in Japan of Zadaxin as a monotherapy treatment for hepatitis B. Data on approximately one-third of the 319 patients indicate that, after six months of therapy and 12 months of follow-up, 24 percent of patients demonstrated a successful interruption of viral replication. Zadaxin has been administered without side effects to more than 10,000 patients and is approved for sale in 26 countries, principally for the treatment of hepatitis B and hepatitis C, and certain cancers, SciClone said. SciClone’s stock (NASDAQ:SCLN) rose 60 cents Tuesday, or 25.9 percent, to close at $2.92.
Sentigen Corp., of New York, a wholly owned subsidiary of Sentigen Holding Corp., said it identified and has a patent pending for an odorant receptor gene, called Or83b, that appears to be common to all species of insects. The discovery suggests that the odorant receptor gene plays a role in olfaction and these results point the way to methods for controlling the behavior of insects. Sentigen’s research may yield products that offer an approach to insect management, it said.