BioTransplant Inc., of Charlestown, Mass., received CE mark approval for its third HDM cell separation product, the Eligix CD8-SC Cell Separation System, for ex vivo use in patients receiving allogeneic bone marrow and peripheral stem cell transplantation. BioTransplant's distribution partner, Gambro BCT, a wholly owned subsidiary of Gambro AB, of Stockholm, Sweden, markets in Europe the Eligix family including the CD8-DLI and BCell-SC systems for use in bone marrow, stem cell and donor leukocyte transplants.
Boston Life Sciences Inc., of Boston, issued a $4 million 10 percent convertible senior secured promissory note to a single institutional investor. The note matures in July 2005 and is convertible into common stock at a conversion price of $2.16 per share. Warrants to purchase a total of 500,000 shares of common stock also were issued that are exercisable through July 2007 to purchase shares of common stock at $2.16 per share. BLSI is developing diagnostics and therapeutics for Parkinson's disease and attention deficit hyperactivity disorder, as well as treatments for cancer, autoimmune disease and central nervous system disorders. Boston Life Science's stock (NASDAQ:BLSI) fell 1 cent Friday to close at 98 cents.
Cohesion Technologies Inc., of Palo Alto, Calif., entered into a definitive agreement to issue about 8.2 million shares of common stock, as well as warrants for up to an additional 911,000 shares, to Three Arch Partners, of Portola Valley, Calif., and Alta Partners, of San Francisco. The per-share price will be the lower of about $1.61, a 10 percent discount to the 15-day average stock closing price ending on July 19, or the 15-day average closing price ending on the third trading day prior to the proxy mail date. Assuming a $1.61 price, net proceeds will be about $12.4 million, which Cohesion said it would use to support an expansion of its direct U.S. sales organization, the initiation of an adhesion prevention clinical study and for general corporate purposes. The financing is expected to close in the fourth quarter.
Cytomedix Inc., of Northfield, Ill., conducted a 1-for-5 reverse split after Thursday's close of business. Certificates representing pre-split shares of common stock have been canceled and will be exchanged for new certificates. The post-split shares began trading under the symbol CYME.
Genmab A/S, of Copenhagen, Denmark, applied to delist from the Frankfurt Stock Exchange and the Neuer Markt, saying that since its October 2000 IPO, more than 95 percent of its share activity has taken place on the Copenhagen Stock Exchange. Genmab added that eliminating the duplication in financial reporting that comes with a double listing would generate savings. Genmab said it would maintain investor and media relations activities for current and potential German investors.
ILEX Oncology Inc., of San Antonio, began a Phase I trial to evaluate the anticancer agent Clofarex (clofarabine) in adults with advanced solid tumors. The open-label, single-arm, dose-escalating study aims to determine the optimal dose and pharmacokinetic profile, as well as safety and tolerability in a weekly schedule for the second-generation nucleoside analogue. Clofarex also is being investigated in Phase II trials in adults with acute myelogenous leukemia and in children with acute lymphocytic leukemia or AML. The studies are part of the clofarabine development collaboration with Bioenvision Inc., of New York.
ImClone Systems Inc., of New York, saw another two-week extension granted to prosecutors in the case against ImClone's former CEO, Sam Waksal. Prosecutors now have until Aug. 9 to file an indictment, while both sides in the case discuss a possible plea. In June, Waksal was charged with insider trading concerning the FDA's rejection of ImClone's cancer drug, Erbitux, and ImClone's resulting stock drop. (See BioWorld Today, June 13, 2002.)
Praecis Pharmaceuticals Inc., of Waltham, Mass., said that, based upon discussions with the FDA, it would seek approval for Plenaxis in a defined subpopulation of advanced prostate cancer patients for whom the use of existing hormonal therapies may not be appropriate. The exact subpopulation will be determined through additional discussions with the FDA. Also, it anticipates resubmitting its new drug application in the first quarter of 2003, and the application will have priority review. The FDA requested more data on Plenaxis in June 2001. Praecis is considering a subsequent submission to the FDA for the use of Plenaxis in a broader advanced prostate cancer patient population. Praecis also said that, based on meetings with European experts, it intends to pursue regulatory approval to commercialize Plenaxis in Europe for the treatment of hormonally responsive advanced prostate cancer patients. Its European regulatory filings would consist of existing data from studies already conducted in the U.S. and Europe, Praecis expects. (See BioWorld Today, June 13, 2001.)
ProQuest Pharmaceuticals Inc., of Lawrence, Kan., said it received a milestone payment as PQ-1002 (Aquavan Injection) entered a Phase II trial in Europe. PQ-1002 is a water-soluble prodrug of propofol, currently the world's best-selling anesthetic. In March 2000, ProQuest licensed the worldwide exclusive development and commercialization rights to PQ-1002 to Guilford Pharmaceuticals Inc., of Baltimore. ProQuest is eligible to receive development milestones and royalties on any product sales. This milestone payment is a third in a series that come to ProQuest as the clinical development of PQ-1002 continues.
Variagenics Inc., of Cambridge, Mass., completed a license agreement with St. Jude Children's Research Hospital in Memphis, Tenn. Variagenics obtained exclusive rights in the field of oncology to develop diagnostic tests predictive of drug response. The agreement covers a patent application claiming CYP3A5 genotyping methods and diagnostic test kits predictive of variable expression of CYP3A5, a member of the CYP3A family that has been associated with the metabolism of a range of cancer therapeutics, including irinotecan.