• Adolor Corp., of Exton, Pa., said David Madden has been appointed chairman of its board. Madden has served as director of Adolor since January 2000 and is the head of the audit committee.

• Adventrx Pharmaceuticals Inc., of San Diego, initiated patient treatment in its international, 300-patient Phase IIb trial to evaluate its lead drug candidate, CoFactor, in combination with 5-fluorouracil for the treatment of metastatic colorectal cancer. The company also said it has received regulatory approval to begin testing in the UK, Germany, Romania, Serbia and India. CoFactor is a folate-based biomodulator drug designed to enhance the activity of chemotherapeutic agent 5-FU, and Adventrx said earlier trials have shown clinical benefit and overall survival in patients with advanced tumors.

• AEterna Zentaris Inc., of Quebec, said the FDA approved an investigational new drug application filed by its North American partner, Spectrum Pharmaceuticals Inc., of Irvine, Calif., for D-63153. The product is a fourth-generation luteinizing hormone-releasing hormone antagonist administered as a depot formulation. Spectrum expects to conduct a Phase I/II trial with D-63153 in hormone-dependent prostate cancer and expand the clinical development in the U.S.

• ArQule Inc., of Woburn, Mass., said it initiated GLP toxicology studies with ARQ 197, the lead in a series of compounds generated through the company's ARQ 650RP cancer survival pathway platform. ARQ197 is designed to selectively induce the death of cancer cells by modulating abnormally elevated levels of certain proteins that promote the survival and proliferation of those cells.

• Australian Cancer Technology Ltd., of Sydney, Australia, said the company's name has changed to Avantogen Ltd. by a vote of shareholders May 9. It also announced the closing of a A$5.7 million (US$4.3 million) 1:3 non-renounceable rights issue, the first of three stages of capital development to advance the company's clinical programs in cancer. The company will continue to be traded on the Australian Stock Exchange under the symbol "ACU."

• Cellectis SA, of Romainville, France, and Celliance, a division of Atlanta-based Serologicals Co., entered a collaboration agreement for Celliance to evaluate Cellectis' Meganuclease Recombination System to develop a new generation of derivative cell lines for production. Financial terms and conditions were not disclosed.

• Centocor Inc., of Horsham, Pa., said its supplemental biologics license application for Remicade (infliximab) in ulcerative colitis has been designated for priority review by the FDA. In Phase III trials, Remicade was evaluated as a monotherapy to test its impact on clinical response, clinical remission and mucosal healing in patients with moderate to severe forms of the gastrointestinal disorder. Remicade previously received approval in Crohn's disease, as well as in rheumatoid arthritis in North America, the European Union and Japan. In other news, Centocor said it has extended a Phase II trial to evaluate the safety and efficacy of CNTO 1275 for reducing the signs and symptoms of active Crohn's disease. CNTO1275 is a human monoclonal antibody that targets interleukin-12 and interleukin-23, proteins that occur naturally in the immune system and are believed to play a role in the inflammation associated with Crohn's.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, entered a nonexclusive commercial license agreement with Pfizer Inc., of New York, in which Pfizer will have the right to use the ACE System to develop cell lines for research, development and manufacturing of Pfizer products. Pfizer will have the right to use the ACE System internally to engineer cells lines for product research, development and manufacturing.

• Evogene Ltd., of Rehovot, Israel, received $1.75 million in new capital from its existing, as well as new, investors from Israel, France and North America. It also reported that Hagai Karchi, who co-founded Evogene in 2002 and has served as CEO since that time, was appointed chief scientific officer. Evogene is focused on developing commercial products based on plant genomics.

• GeneGo Inc., of St. Joseph, Mich., said that the National Cancer Institute licensed MetaCore 2.5, GeneGo's platform for mining of high-throughput experimental data in the context of biological networks, pathways and diseases.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, filed an investigational new drug application with the FDA to begin Phase I trials in volunteers with Neumune (HE2100) in the U.S. Neumune is being developed for the treatment of acute radiation syndrome. Hollis-Eden is developing Neumune under an FDA rule designed for medical countermeasures to weapons of mass destruction.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., completed enrollment of its Phase IIb trial of valopicitabine (NM283) with more than 170 treatment-refractory hepatitis C genotype 1 patients. The company said it is the first time a direct antiviral drug has reached that stage of clinical testing for that patient population.

• Jivan Biologics Inc., of Berkeley, Calif., launched the first commercial genome-wide microarrays for alternative splicing. The microarrays were manufactured by Palo Alto, Calif.-based Agilent Technologies Inc. Jivan's TransExpress Whole Spliceome enables researchers to detect changes in RNA splicing across the human genome.

• La Jolla Pharmaceutical Co., of San Diego, said it has received fast-track designation for Riquent (abetimus sodium) for the treatment of lupus renal disease. In October, the FDA told La Jolla the drug was "approvable" pending the completion of a clinical benefit trial, which is ongoing, though the company said it had halted further patient enrollment until additional funding can be obtained. With limited financial resources, La Jolla said it would need to conduct a financing round or sign a collaboration agreement in the near future to continue operations past the first quarter of 2006. The company's shares (NASDAQ:LJPC) rose 40 cents, or 100 percent, Tuesday to close at 80 cents.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., received clearance from the FDA for its Tarvacin antiviral investigational new drug application. The initial clinical protocol under the IND is a Phase I dose-escalation study designed to evaluate a single intravenous infusion of Tarvacin in up to 32 patients with chronic hepatitis C virus infection who have failed to respond or who have relapsed after the current standard treatment with pegylated interferon plus ribavirin.

• Pharmos Corp., of Iselin, N.J., said its board approved a 1-for-5 reverse split of its common stock. Beginning Tuesday, the company's stock began trading for 20 trading days under the symbol "PARSD" on Nasdaq. The reverse split will reduce the number of shares of the company's common stock outstanding from about 95.1 million shares to about 19 million shares.

• Sanguine Corp., of Pasadena, Calif., said it has chosen the transportation of islet cells as its primary indication of PHER-02. The company based its decision on the oxygen-carrying attribute of PHER-02 and the work completed by certain universities. The FDA has approved the first-generation product, Fluosol DA, for angioplasty, but physicians have used the product as an oxygen carrier for patients that will not or cannot take blood products.

• Tercica Inc. and its co-plaintiff, Genentech Inc., both of South San Francisco, have filed a motion for a preliminary injunction against Richmond, Va.-based Insmed Inc. and its acquired company Celtrix Inc., of Santa Clara, Calif., in the U.S. District Court for the Northern District of California. Tercica is developing Increlex, or recombinant human insulin-like growth factor-1, as a treatment for short stature caused by primary IGF-1 deficiency. The injunction seeks to prevent Insmed and its predecessor company, Celtrix, from making, using, offering to sell, or selling SomatoKine, and to compel Insmed to grant Tercica joint exclusivity in any orphan drug marketing right that Insmed might receive if the new drug application for SomatoKine is approved by the FDA before the NDA for Increlex. The suit claims willful infringement of three U.S. patents relating to the combination of IGF-1 and IGFBP-3, and its use for the treatment of short stature. Insmed submitted the SomatoKine NDA in January. (See BioWorld Today, Jan. 5, 2005.)

• Transport Pharmaceuticals Inc., of Framingham, Mass., initiated a Phase III trial using its device/drug combination product for the delivery of acyclovir. The trial will study the safety and efficacy of a single application of acyclovir cream in patients with recurrent herpes labialis lesions using Transport's system tested against placebo and a conventional formulation. A Phase II study of acyclovir demonstrated that rapid delivery of high doses of the medication significantly reduced the duration of the cold sore lesions.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said it plans to offer 9.5 million shares of its common stock in an underwritten public offering. The offering will be made pursuant to the company's shelf registration statement. Vertex also expects to grant underwriters a 30-day option to purchase about 1.4 million shares to cover overallotments. Vertex develops small molecules to treat viral diseases, inflammation, autoimmune diseases and cancer.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., filed an amendment to its existing anidulafungin new drug application with the FDA to treat esophageal candidiasis. The amendment provides supplemental clinical data on the 100-mg dose of anidulafungin from the Phase III trial that demonstrated superiority of anidulafungin vs. fluconazole in invasive candidiasis/candidemia. The company expects to file a new NDA for the treatment of invasive candidiasis/candidemia in the third quarter.