Ambrx Inc., of San Diego, appointed Martin Mattingly president and CEO. He previously served as executive vice president and chief operating officer at Carlsbad, Calif.-based CancerVax Corp. Mattingly also will join the company's board. Ambrx is focused on protein therapeutics.
Bio-Medisinsk Innovasjon AS, of Oslo, Norway, entered an exclusive global license and development agreement with London-based GlaxoSmithKline plc, concerning the 5-HT4 receptor antagonist piboserod (SB 207266). Under the agreement, BMI will be responsible for completing a Phase II program to evaluate the product's effect on heart failure patients. If that trial is successful, GSK has the option to continue development, and eventual marketing of the drug, in exchange for a license fee, milestone payments and potential royalties.
Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, signed the University of Virginia's Martin Schwartz to develop compounds that treat vascular leak. The agreement ensures full transfer of relevant technology and gives Cryptome the first option to in-license intellectual property produced in Schwartz's laboratory. Schwartz invented CR014, the first peptide compound with broad spectrum activity against vascular leak. Cryptome is in negotiations with Schwartz to in-license CR014.
Curis Inc., of Cambridge, Mass., entered a research and development agreement with Proctor & Gamble Pharmaceuticals, a division of Cincinnati-based Procter & Gamble Co., to evaluate and develop treatments for hair growth using Curis' Hedgehog agonist technology. Curis scientists have demonstrated that small-molecule Hedgehog agonists can induce hair growth in preclinical models. Curis will retain rights to veterinary applications of the technology and to certain non-systematic applications.
Cytheris SA, of Paris, started a fifth Phase I study in the Memorial Sloan Kettering Cancer Center of its lead compound, a recombinant interleukin-7, in patients with myeloid malignancies who underwent a T cell depleted allogenic hematopoietic cell transplant. The product is a pivotal growth factor that helps to reconstitute the immune system and enhance global and specific immune responses.
Durect Corp., of Cupertino, Calif., completed dosing in the third and final cohort of the Phase II study of SABER-Bupivacaine in hernia patients in Australia. The company enrolled about 60 patients in cohort three, and the results are being analyzed. SABER-Bupivacaine is based on Durect's SABER delivery technology and is intended to be administered around the surgical site after surgery to provide three days or more of regional pain relief.
Emisphere Technologies Inc., of Tarrytown, N.Y., completed dosing of all arms of a clinical trial to compare heparin delivered by intravenous and subcutaneous injection to the company's oral heparin capsule formulation, which uses the eligen technology. The trial is meant to demonstrate that heparin delivered orally by the eligen technology remains unaltered and has the same molecular composition as heparin administered by the subcutaneous or intravenous routes of administration. The company expects to present final results to the FDA as soon as possible.
EvoGenix Ltd., of Melbourne, Australia, received worldwide licensing rights from South Korea-based DiNonA for an antibody for the treatment of leukemia. The antibody, discovered by researchers at the University of Seoul, targets certain forms of acute adult leukemia for which current antibody drugs provide little benefit.
GeneGo, of St. Joseph, Mich., said that its MetaCore software applications has achieved GeneChip-compatible status with the Affymetrix Inc., of Santa Clara, Calif., GeneChip microarray platform and that it has joined the Affymetrix GeneChip-compatible applications program, which provides customers with a spectrum of software solutions for biomedical research and development.
GenTel BioSurfaces Inc., of Madison, Wis., launched PATH HTS, a platform for high-throughput immunoassays. The system includes accessories to enable use with existing microarray instrumentation, including microarray spotters and scanners.
GlobeImmune Inc., of Denver, will be using the Prism Electronic Data Capture software developed by Nextrials Inc., of San Ramon, Calif., to conduct two upcoming trials for an oncology therapeutic. GlobeImmune, which discovers and manufactures Tarmogen-based products to treat cancer and infectious diseases, previously used the Prism system for a clinical study in chronic hepatitis C infection.
GlycoGenesys Inc., of Boston, said data for its cancer drug candidate GCS-100 were presented at the XI International Work Shop on Chronic Lymphocytic Leukemia in New York. When treated with GCS-100, a variety of lymphoma and myeloma cell lines and chronic lymphocytic leukemia primary patient cells showed distinct down-regulation of AKT1 in a dose dependent manner. And cell lines treated with GCS-100 inhibited the activity of VEGF, a pro-angiogenic factor.
ImClone Systems Inc., of New York, said its board approved a stock repurchase program to buy up to $100 million in aggregate principal amount of outstanding shares of the company's common stock during the next two years. The program is to be employed for general corporate purposes, including the offsetting of dilution resulting from future grants of stock options or other dilutive incentive compensation granted to employees and directors.
Inex Pharmaceuticals Corp., of Vancouver, British Columbia, received a copy of a demand letter for repayment from Stark Trading and Shepherd Investments International Ltd. of $24.6 million in convertible debt by Sept. 21. The majority holder has alleged the notes are in default by Inex's subsidiary, Inex International Holdings Ltd., because Inex is unable to pay its debts as they mature or become due. Inex disagreed and intends to oppose any action taken by Stark, it said.
Ixion Biotechnology Inc., of Alachua, Fla., said Stephen Bartelmez joined the company as president and CEO, as the company begins to focus exclusively on cellular therapy for diabetics. Prior to Ixion, Bartelmez served as director of research at stem cell company HemoGenix Inc., of Colorado Springs, Colo. Former president and CEO, Weaver Gaines, will remain chairman of Ixion's board.
Karo Bio AB, of Huddinge, Sweden, completed the first single, ascending-dose portion of its Phase I study for KB2115 in overweight subjects with dyslipidemia. Findings indicated that a single dose of the drug did not cause any adverse effects, and appeared to have positive effects on blood lipids and metabolic markers. The company now has initiated the multidose Phase Ib part of the study. KB2115 is designed to selectively stimulate the thyroid receptor to increase the body's energy consumption and reduce body weight.
MedImmune Inc., of Gaithersburg, Md., submitted a supplemental biologics license application for approval to use CAIV-T (cold adapted influenza vaccine, trivalent) in preventing influenza in healthy individuals 5 to 49 years of age. CAIF-T is the company's investigational, refrigerator-stable formulation of FluMist (influenza vaccine live, intranasal), a frozen vaccine approved to prevent the flu in healthy children and adolescents, 5 to 17 years of age, and in adults, ages 18 to 49.
Medivation Inc., of San Francisco, acquired a series of small-molecule compounds (the MDVN 300 series) targeting hormone-refractory prostate cancer. The compounds were discovered by Charles Sawyers, Peter Bing and a medical investigator at the University of California in Los Angeles. The company intends to begin clinical development with those compounds by the end of the year.
NewGen Technologies Inc., of Charlotte, N.C., signed an agreement with Advanced Biotechnology Inc. to form a joint venture with New Gen's subsidiary, ReFuel America Inc., to build and operate biodiesel plants in the Southeast. The new company will be named Advanced Biotechnologies LLC, and its first facility will be in Sandersville, Ga.
Novagali Pharma, of Evry, France, completed a Phase I trial of its oral formulation of paclitaxel, Noval2005, with advanced cancer patients. The study showed that the product was safe and well tolerated and had high bioavailability. The company believes that repeated oral schedules of the drug should enable the maintenance of therapeutic levels for at least eight hours after administration. The company is seeking a partner for further development.
Oscient Pharmaceuticals Corp., of Waltham, Mass., said a five-day course of therapy with Factive was shown to be as effective in treating mild to moderate community-acquired pneumonia as the FDA-approved seven-day course of treatment, with both arms displaying excellent clinical response rates. Data from the non-inferiority Phase III trial are being presented at the Second International Conference on Community-Acquired Pneumonia in Montreal. Further data showed that the bacteriological and radiologic success rates with five days of therapy also were non-inferior to the success rates with seven days of therapy.
Point Therapeutics Inc., of Boston, completed the first stage of its Phase II study of talabostat with rituximab for the treatment of advanced chronic lymphocytic leukemia. The study has garnered a 20 percent response rate in the first 20 patients. The majority of patients in the study had previously not responded to or had relapsed following prior treatment with rituximab and/or fludarabine, suggesting that the addition of talabostat provides benefit.
Spectrum Pharmaceuticals Inc., of Irvine, Calif., completed its $42 million financing by issuing 8 million shares at $5.25 apiece. The purchasers also received six-year warrants to purchase up to 4 million shares at $6.62 apiece. Rodman and Renshaw LLC acted as the exclusive placement agent, and net proceeds will be used for general corporate purposes. (See BioWorld Today, Sept. 16, 2005.)
Stem Cell Therapy International Inc., of Tampa, Fla., signed an exclusive global licensing agreement with the Institute of Cell Therapy, a biotech company headquartered in Kiev, Ukraine, for the supply of stem cells and use of 26 related patents. Stem Cell Therapy was granted rights to use the intellectual property contained in the patents, the stem cell products and the process itself, to establish clinics for the treatment of patients, set up cryo-storage facilities and administer stem cell products to customers. Financial terms were not disclosed.
StemCells Inc., of Palo Alto, Calif., filed with the FDA an amendment to its initial investigational new drug application to begin a clinical trial of its human neural stem cells as a treatment for Batten disease. The proposed Phase I trial has been on hold since February, pending a complete response to questions and concerns presented to the company by the FDA.
Transgenomic Inc., of Omaha, Neb., received notification from The Nasdaq Stock Market that the company regained compliance with the $1 minimum bid price requirement for continued listing on Nasdaq's National Market. Transgenomics provides research tools and related consumable products.
Unigene Laboratories Inc., of Fairfield, N.J., and Yale University in New Haven, Conn., executed agreements to enable Unigene to acquire exclusive rights to their jointly owned inventions for procedures that might provide physicians with new methodologies for treating and preventing fractures more effectively. Patent applications were filed for two inventions.
Viventia Biotech Inc., of Toronto, received clearance from the FDA to begin a Phase II study evaluating Proxinium for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer. Proxinium combines a cytotoxic protein payload with the tumor-targeting characteristics of a monoclonal antibody.