• Adventrx Pharmaceuticals Inc., of San Diego, has finalized a Clinical Trial Cooperative Research and Development Agreement under which Department of Veterans Affairs clinical sites may participate in the company's Phase III clinical trial of ANX-510 (CoFactor) for the treatment of metastatic colorectal cancer. Thus far three agreements have been signed with regional VA centers. The 1,200 patient, randomized clinical trial is being conducted in up to 100 sites across the U.S. abroad and overseas. Patients will be randomized to two arms containing either CoFactor or leucovorin, each in combination with chemotherapy agent 5-fluorouracil (5-FU) and bevacizumab (Avastin, Genentech). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.
• A.P. Pharma Inc., of Redwood City, Calif., said its Nasdaq Global Market-listed shares would reflect a 1-for-4 reverse stock split beginning today. Prior to the split, the specialty pharmaceutical company had about 25.4 million shares outstanding.
• Chemokine Therapeutics Corp., of Vancouver, British Columbia, amended certain terms of its 8-year-old license agreement with the University of British Columbia to grant the company exclusive worldwide rights to certain patented technologies that remain the school's property. The licensed technology relates to therapeutics involving stromal cell-derived factor 1, or SDF-1, peptide antagonists and agonists that currently are applicable to Chemokine's drug candidates CTCE-9908 and CTCE-0214, respectively.
• CV Therapeutics Inc., of Palo Alto, Calif., lowered its operating expense guidance for 2007 by about $75 million, consolidated sales territories and will eliminate an undisclosed number of sales and headquarter jobs. Operating expenses are planned to drop from up to $285 million to $200-$210 million over the next four quarters. The company has reduced general and administrative expenses for the next year by approximately 15 percent. In total, SG&A expenses in the U.S. will be reduced by $55-$60 million, or approximately 33 percent over that time period. The company expects $16-$20 million in one-time expenses and charges in the second quarter of 2007 related to the cutbacks. R&D spending also is expected to be reduced by almost 20 percent, or $15-$20 million on an annual basis. The company's lead product is Ranexa (ranolazine extended-release tablets), which won approval early last year for the treatment as a second- and third-line use in chronic angina. Sales of the angina product for the first quarter of 2007 totaled about $12 million. Earlier this month, it filed a new drug application for regadenoson as a stress agent in myocardial perfusion imaging tests. (See BioWorld Today, May 16, 2007.)
• Debiopharm Group, of Lausanne, Switzerland, said its three-month, sustained-release formulation of Salvacyl/Moapar completed the European mutual recognition procedure in Germany, Belgium, Denmark, Finland, France, Norway, the Netherlands and the UK. Last year, the gonadotropin-releasing hormone agonist analogue for sexual deviations was approved in Sweden, which was the reference member state. The company is seeking a commercial partner for the product's sales and marketing.
• Hemosol Corp., of Toronto, said the Ontario Superior Court of Justice granted a further extension of the stay of proceedings against it until May 31. The further extension will allow negotiations to continue with Hemosol's primary secured creditor, Catalyst Fund Limited Partnership II, and between Catalyst and certain stakeholders. The plan is to sell the assets and business to Catalyst.
• MethylGene Inc., of Montreal, reported preliminary preclinical results at the American Society for Microbiology meeting in Toronto, showing the synergy of its histone deacetylase candidate MGCD290 with the antifungal agents itraconazole, voriconazole, terbinafine and fenpropimorph in various Candida species. Further data demonstrated that when the combinations of MGCD290 and itraconazole or voriconazole are used against C. glabrata, the post-antifungal effects and fungal cidal activity are increased when compared to the administration of each drug alone.
• Neose Technologies Inc., of Horsham, Pa., has received a milestone payment from Novo Nordisk A/S, of Bagsvaerd, Denmark, under a 2003 license agreement for the use of Neose's GlycoPEGylation technology to develop a next-generation version of Factor IX. The company also is working with Novo Nordisk to develop next-generation versions of Factors VIIa and VIII. Factor IX products are used in the treatment of hemophilia B. Hemophilia B, also known as Christmas disease, is caused by a deficiency of a blood plasma protein called Factor IX that affects the clotting property of blood. The amount of the payment was not disclosed.
• Quest PharmaTech Inc., of Edmonton, Alberta, signed an agreement with the Alberta Research Council to develop fermentation-based technology to manufacture Hypocrellin B, an ingredient for SonoLight Technology-based products including SL017 for dermatology and SL052 for cancer. Currently, the company procures Hypocrellin B from a mushroom that grows on bamboo trees in China, but going forward would like to control the manufacturing and scale-up process and also reduce raw material costs through the new arrangement. The Alberta Research Council will undertake research to develop a semi-synthetic method to manufacture Hypocrellin B, and if successful, Quest will receive an exclusive license to the developed technology to manufacture and commercialize Hypocrellin B-based products.
• Sciele Pharma Inc., of Atlanta, gained exclusive U.S. rights from Plethora Solutions Holdings plc, of London, to PSD502, which has completed Phase II trials for treating premature ejaculation. As part of the deal, Sciele is purchasing a $7 million equity stake in Plethora. Plethora also is entitled to undisclosed regulatory and sales milestone payments, as well as royalties on sales. It also would have co-promotion rights for urologists in the U.S. PSD502 is a rapidly absorbed formulation of two well-established local anesthetics, lidocaine and prilocaine, dispensed in a metered-dose spray. Plethora expects to begin a Phase III study in the second half of this year.
• Targanta Therapeutics Corp., of Cambridge, Mass., presented research data showing its antibiotic oritavancin has potential for treating exposure to Bacillus anthracis, the bacterium that causes anthrax infection. Oritavancin is a semi-synthetic lipoglycopeptide antibiotic in Phase III trials for treating Gram-positive infections. Research in anthrax was conducted with the U.S. Army Medical Research Institute of Infectious Diseases, and presented at the American Society for Microbiology meeting in Toronto.
• Tripos Inc., of St. Louis, remains in continued non-compliance with the minimum $10 million stockholders' equity requirement for continued inclusion on the Nasdaq Global Market. The company, which has sold its discovery informatics business, is in the process of selling its discovery research products and services business to become a shell company. It is not in compliance with another rule for failing to file its quarterly report for the period ended March 31 in a timely manner.
• Viragen Inc., of Plantation, Fla., said it appealed the delisting notice it received from the American Stock Exchange. The shares will continue trading on AMEX pending the hearing panel's determination. The hearing is expected to take place within 45 days.
• YM BioSciences Inc., of Mississauga, Ontario, said the manufacturing facility for its cancer antibody nimotuzumab has been scaled up to a 500-liter capacity, continuous-perfusion fermentation process, and Canadian and European regulators have certified the site. The company plans double its capacity later this year.