Agenix Ltd., of Brisbane, Australia, signed a contract with Research Triangle Park, N.C.-based Diosynth Biotechnology to begin the process of manufacturing ThromboView for Phase III trials and commercial sales. Diosynth is expected to supply the product so Agenix can begin the pivotal trials by the third quarter of next year.
Biotech Holdings Ltd., of Vancouver, British Columbia, filed for a private placement of C$121,574 (US$100,000). The company will issue 419,220 shares at a price of C29 cents per share, with each share having a warrant exercisable at C38 cents for the purchase of an additional share. Proceeds from the investment will be used to continue the company's advertising in Mexico for its Type II diabetes medication, Sucanon.
ChondroGene Ltd., of Toronto, entered an alliance with the University of California in San Francisco to provide the framework for future collaboration with UCSF scientific researchers and clinicians in applying the Sentinel Principle to diagnostic and therapeutic uses in a range of diseases.
Cytomedix Inc., of Rockville, Md., completed the treatment phase of the company's clinical trial involving 72 patients at 14 sites designed to test the safety and effectiveness of its AutoloGel System for diabetic foot ulcers. Data were obtained through a 12-week patient treatment program under an FDA-approved, prospective, randomized, blinded and controlled study.
CytRx Corp., of Los Angeles, said the FDA has cited two actions needed by CytRx in order to lift the clinical hold placed on its oral drug arimoclomol to treat amyotrophic lateral sclerosis: a submission of existing clinical information on the company's related small-molecule drug candidate bimoclomol, which has been tested more extensively than arimoclomol; and an amendment to the clinical trial's protocol, which adds specific tests to be administered to patients enrolled in the study.
Galapagos NV, of Mechelen, Belgium, along with ZoBio BV, of Leiden, the Netherlands, and Pyxis Discovery BV, of Delft, the Netherlands, formed a four-way collaboration with Leiden University to pursue a small-molecule drug discovery program in the area of arthritis. Galapagos will contribute its arthritis disease biology and a validated target for drug development. The two-year collaboration will be funded in part by a €1.2 million (US$1.5 million) grant from the Dutch Ministry of Economic Affairs.
Genoptix Inc., of San Diego, completed a $17.3 million Series D financing. Chicago Growth Partners joined existing investors Enterprise Partners, Alliance Technology Ventures, Tullis-Dickerson & Co. Inc., U.S. Trust's Excelsior Venture Partners III LLC and Lotus Bioscience Investment Holdings, among others. Genoptix provides personalized medicine services through its CLIA and CAP certified laboratory to hematologists and oncologists.
Macogen Inc., of Seoul, South Korea, and Applied Biosystems Group, of Foster City, Calif., said that Macogen will provide gene expression analysis services using the Applied Biosystems Expression Array System to the National Institute of Toxicological Research (NITR) under the Korean Food and Drug Administration (KFDA).
Orthogen AG, of Dusseldorf, Germany, said results of a 400-patient trial of Orthokine showed the product to be safe and effective in treating osteoarthritis. Results also indicated that Orthokine was superior to hyaluronic acid injection therapy and placebo. The product is designed to target the mechanism of arthritis and prevent further cartilage degeneration in the joints.
Pfizer Inc., of New York, submitted a new drug application to the FDA for its cancer medicine SU11248 (sunitinib malate), or Sutent. Pfizer is seeking approval of Sutent as a treatment for malignant gastrointestinal stromal tumor and metastatic renal cell carcinoma among patients whose tumors do not respond to or do not tolerate standard treatment options. Sutent is one of the first in a new class of drugs that selectively targets receptor tyrosine kinases.
Trigen Holdings AG, of Munich, Germany, said preliminary results of a Phase II study of its intravenous anticoagulant drug, TGN 255, indicated that the drug provided effective and convenient anticoagulant cover in 28 patients undergoing hemodialysis, with a high level of control, and with no increase in bleeding risk. Results were presented at the Congress of the International Society on Thrombosis and Haemostasis meeting in Sydney, Australia. Trigen said final data from the study is expected in the fall.
Valeant Pharmaceuticals International, of Costa Mesa, Calif., reported that it has sold its raw materials and manufacturing operations in Hungary to Sun Pharmaceuticals Industries Ltd., of Mumbai, India. Terms of the transaction were not disclosed. Valeant is a specialty pharmaceutical company that discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious diseases and dermatology.
YaSheng Group, of Redwood City, Calif., said its research and development team mastered a gene cloning process that allows the creation of fortified cells to combat foot-and-mouth disease. Development is underway for a vaccine to eliminate the disease in live animals.
ZymoGenetics Inc., of Seattle, said four Phase II studies of its recombinant human Thrombin (rhThrombin), in development to control bleeding during surgery, showed that the product was safe and well tolerated with a favorable immunogenicity profile. The trial involved about 130 patients undergoing spinal surgery, liver resection, peripheral artery bypass or arteriovenous graft construction. These data were presented at the annual International Society on Thrombosis and Haemostasis meeting in Sydney, Australia.