• Adventrx Pharmaceuticals Inc., of San Diego, said response data from 48 patients in its Phase II trial of its biomodulator drug, CoFactor, in combination with 5-fluorouracil as a first-line treatment for metastatic colorectal cancer, showed that 65 percent, or 31 patients, achieved clinical benefit, defined as tumor response or stable disease. Objective response data showed 18 patients responded to treatment, surpassing the trial's primary endpoint objective of 25 percent. The results were presented at the 7th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

• Agilent Technologies Inc., of Tokyo, signed an agreement with Japanese bioventure Human Metabolome Technologies to collaborate on a set of metabolome analysis tools designed to help researchers discover therapeutics. The companies will use HMT's biochemical assays with Agilent's capillary electrophoresis and mass spectrometry technology to identify metabolic biomarkers.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., said it successfully completed a Phase II trial of TeraCLEC, an orally available recombinant enzyme replacement therapy, in cystic fibrosis. The drug was well tolerated by patients, and the trial achieved its primary endpoint by showing a statistically significant improvement in fat absorption. The company expects to present further trial results in October.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Taconic Farms Inc., of Germantown, N.Y., formed an alliance for the generation, marketing and delivery of genetically engineered rodents. The alliance combines Artemis' technology platform in mouse genetics and genomics with Taconic's expertise in rodent breeding, quality control, global marketing and distribution.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said the FDA granted fast-track status to the development of Fodosine (forodesine hydrochloride) for the treatment of relapsed or refractory T-cell leukemia. Fodosine is a transition state analogue inhibitor with strong binding to the target enzyme. Currently being studied in a Phase IIa trial, Fodosine is BioCryst's lead product.

• BioInvent International AB, of Lund, Sweden, initiated Phase I/IIa studies of BI-201 to treat HIV infection. The first patients at Chelsea & Westminster Hospital in London have received the first dose. The trial will assess safety, tolerability and pharmacokinetic properties, as well as the effect on the viral load. The study is expected to be presented in the second quarter of 2006. BI-201 is a human antibody selected from the company's n-CoDeR antibody library for its ability to bind to the TAT protein.

• BioLineRx Ltd., of Jerusalem, said it exclusively in-licensed two therapeutic candidates: BL-2030, a soluble receptor that targets multiple types of cancer, licensed from BioRap Technologies Ltd. in Israel, and BL-2040, a small molecule to treat metabolic syndromes, licensed from Yeda Research and Development Company Ltd., the technology transfer of the Weizmann Institute of Science.

• Carna Biosciences Inc., of Kobe, Japan, and CrystalGenomics Inc., of Seoul, South Korea, signed a service agreement with South San Francisco-based Rigel Pharmaceuticals Inc. in the field of structure-based design, which focuses on structural analysis of disease targets in the presence or absence of therapeutic compounds.

• CepTor Corp., of Hunt Valley, Md., redeemed 85 percent of the shares held by New Brunswick, N.J.-based Xechem International Inc. set to be canceled, representing an anti-dilution of about 24 percent. CepTor purchased about 2.9 million shares of its stock from Xechem for cash at a market discount. Xechem will retain 500,000 restricted shares, or about 4 percent, of the company's shares outstanding.

• Compugen Ltd., of Tel Aviv, Israel, is collaborating with Biosite Inc., of San Diego, for the development and commercialization of diagnostic products. Biosite got a license to immunoassay-based diagnostic products using biomarkers discovered by Compugen. Compugen is expected to provide Biosite with data on several gene targets to be nominated by Biosite.

• CV Therapeutics Inc., of Palo Alto, Calif., and Solvay Pharmaceuticals Inc., of Marietta, Ga., said the FDA extended the PDUFA date for the Aceon (perindopril erbumine) tablets supplemental new drug application by 90 days to allow additional time for clinical site audit activities. The PDUFA date now is Sept. 10.

• CyGenics Ltd., of Melbourne, Australia, said it formed a new subsidiary, CytoVations, headquartered in New Jersey, to address needs of the U.S. cell therapy market. CytoVations will assess intellectual property and assist with the development of products, and is designed to complement the work of two CyGenics' divisions, specifically Boston-based Cytomatrix, which focuses on cell therapeutics, and Singapore-based Cell Sciences, which develops consumable cell culture products.

• CytRx Corp., of Los Angeles, submitted a reply to the FDA that included additional documents for its investigational new drug application filing for arimoclomol in amyotrophic lateral sclerosis. Upon receipt by the FDA, the company expects a 30-day waiting period prior to initiating a Phase II trial. Arimoclomal, believed to stimulate normal cellular protein repair pathways through the activation of molecular chaperones, previously was granted orphan drug status.

• DiaDexus Inc., of South San Francisco, said the FDA granted marketing clearance for the PLAC test, making it the first blood test to aid in predicting risk for ischemic stroke associated with atherosclerosis. The PLAC test measures an enzyme in the blood called lipoprotein-associated phospholipase Az.

• Diversa Corp., of San Diego, said it expanded its existing agreement with Whitehouse Station, N.J.-based Merck & Co. Inc. for the development of therapeutic antibodies. Under the expanded agreement, Diversa will receive an additional up-front payment and research funding, and will be entitled to receive milestones based on successful development of antibody candidates as well as royalties on any product sales. The companies signed the initial agreement in January to apply Diversa's MedEv antibody evolution platform in a joint development program.

• Durect Corp., of Cupertino, Calif., reported positive preliminary results from the second cohort of an ongoing Phase II study of its post-operative pain relief candidate, SABER-Bupivacaine, in hernia patients. The company said patients treated with the drug reported better overall mean pain relief over the four days compared to those receiving commercial bupivacaine. The results were presented at the International College of Surgeons 39th North American Federation Congress in Acapulco, Mexico.

• Endotis Pharma, of Paris, received €4 million (US$4.9 million) in a Series A financing round from investor Sofinnova Partners, also of Paris. Founded in February 2003, Endotis specializes in glycoscience, which includes the exploitation of protein-sugar interactions, in discovering and developing therapeutics for cancer and inflammatory diseases. The funding will be used to build up the company's team and facilities, as well as accelerate the development of antibodies against Endocan, a proteoglycan believed to be involved in tumor progression.

• Galapagos NV, of Mechelen, Belgium, entered a services agreement with Celera Genomics Group, of Rockville, Md. Galapagos' services division, Galadeno, will provide technology and adenoviral reagents enabling Celera to analyze gene function in human cells and validate potential drug targets. Galadeno will receive payments related to its services and technology. Galadeno will construct recombinant adenoviruses harboring genes selected by Celera. Those custom-made viruses will be used to introduce the genes into various cell types to evaluate their function.

• GNI Ltd., of Tokyo, and Shanghai Genomics Inc., of Shanghai, China, have merged their drug development technologies to streamline GNI's discovery, preclinical and clinical programs. Christopher Savoie will serve as CEO of GNI, while Ying Luo will be the company's president and Jun Wu will be appointed chief scientific officer. Along with the merger, GNI completed a private equity financing round of more than $13 million, led by U.S. and Japanese equity firms.

• Halozyme Therapeutics Inc., of San Diego, launched Cumulase worldwide for the treatment of oocytes to facilitate certain in vitro fertilization procedures. Cumulase, a recombinant human hyaluronidase, received FDA approval in April and received approval in the European Union in December.

• iCeutica Inc., of Philadelphia, said it completed its Series A equity financing led by Phoenix IP Ventures, also of Philadelphia. The company said funds will be used to launch its operations in the U.S. and Western Australia. iCeutica develops reformulations of commercially successful compounds using nano-reformulation technology. The company added Eugene Cooper and Dennis Langer to its board.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., and Seattle-based Rosetta Biosoftware agreed to establish interoperability between Rosetta's Resolver system and Inconix's DrugMatrix Informatics System. That will allow researchers to analyze and manage DrugMatrix data, their own data and data from other sources using Rosetta's system.

• ImClone Systems Inc., of New York, said it intends to submit a supplemental biologics license application for Erbitux (cetuximab) to treat head and neck cancer, as a single agent and in combination with radiation, during the third quarter. Erbitux was approved last year in combination with irinotecan for the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory or intolerant to irinotecan.

• Kara Bio AB, of Huddinge, Sweden, initiated Phase I studies of KB2115, which is being developed for obesity and dyslipidemia. The trial will be a randomized, double-blind, placebo-controlled study in healthy but overweight males and females with elevated blood lipids.

• MedImmune Inc., of Gaithersburg, Md., and Avalon Pharmaceuticals Inc., of Germantown, Md., said they are collaborating to discover and develop small-molecule compounds in the area of inflammatory disease. Avalon will use its drug discovery engine to identify lead compounds, while MedImmune will be responsible for further development and marketing activities. Specific terms were not disclosed, though Avalon stands to receive an up-front payment, as well as research and development support, milestone payments and royalties. MedImmune has the option of adding two more collaborations with Avalon under similar terms.

• MNLpharma Ltd., of Reading, UK, said preclinical studies evaluating several antifungal compounds showed that terbinafine-resistant strains of S. cerevisiae were highly susceptible to MNL's compounds. Data demonstrated an activity profile and a mechanism that potentially is different than existing products. The results were presented at the BIO 2005 meeting in Philadelphia.

• Myriad Genetics Inc., of Salt Lake City, said results of its Phase II trial of Flurizan in patients with mild to moderate Alzheimer's disease showed that those who received the 800-mg twice-daily dose of Flurizan achieved between 34 percent and 45 percent slowing in decline on the three primary endpoints: activities of daily living, overall function and cognitive ability. Myriad said a 20 percent or greater slowing in decline is considered statistically significant. While patients with moderate Alzheimer's did not appear to benefit from treatment, the company reported that they did show a positive trend. Results were presented at the Alzheimer's Association International Conference on Prevention of Dementia in Washington

• Odyssey Thera Inc., of San Ramon, Calif., signed an agreement with Lexicon Genetics Inc., of The Woodlands, Texas, to characterize the pathway activity of certain Lexicon compounds in human cells using Odyssey Thera's protein-fragment complementation assay strategy. Financial terms were not disclosed.

• PharmaFrontiers Corp., of The Woodlands, Texas, raised about $5.1 million through a private placement. The company issued about 3.4 million units, comprised of one share of common stock and three separate types of warrants to purchase 2.75 shares, at a price of $1.50 per unit.

• Phase Bioscience Inc., of Durham, N.C., appointed Gabriel Cipau CEO and chairman and Cindy Clark president and chief business officer. Cipau is a partner with Key Partner Consulting. He has held president and CEO roles at Copley Pharmaceuticals and Catalytica Pharmaceuticals and was interim CEO and board member at Biolex. Clark most recently was chief business officer for Erimos Pharmaceuticals.

• pSivida Ltd., of Perth, Australia, entered a collaboration with the Ian Wark Research Institute at the University of South Australia to evaluate its BioSilicon platform for the delivery of protein and peptide-based therapeutics. The company said its preliminary investigations using BioSilicon have indicated its potential for the development of controlled-release formulations of existing therapeutics.

• Sanaria Inc., of Rockville, Md., received a three-year Phase II Small Business Innovation Research grant, totaling up to $3 million, from the National Institute of Allergy and Infectious Diseases. Sanaria is developing an attenuated malaria sporozoite vaccine against Plasmodium falciparum, the malaria parasite responsible for more than 95 percent of malaria-associated severe illness and death worldwide.

• Seattle Genetics Inc., of Bothell, Wash., said it licensed its antibody-drug conjugate technology to PMSA Development Co. LLC (PDC), a joint venture between Tarrytown, N.Y.-based Progenics Pharmaceuticals Inc. and Princeton, N.J.-based Cytogen Corp. The license gives PDC rights to use the technology to link cell-killing drug payloads to its fully human monoclonal antibodies targeting prostate-specific membrane antigen. Terms of the agreement call for Seattle Genetics to receive a $2 million up-front fee, as well as progress-dependent milestones and royalties from any resulting products.

• SkyePharma plc, of London, said the German regulatory authority has approved Foradil Certihaler (formoterol fumarate inhalation powder) for the treatment of asthma and chronic obstructive pulmonary disease. The product was co-developed by Novartis Pharma AG, of Basel, Switzerland.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, said it initiated dosing in a Phase Ib trial for TG-873870, a quinolone antibiotic with the potential for treating drug-sensitive and drug-resistant bacterial infections. The multi-dose tolerance and safety study is being conducted in the U.S.

• Theratechnologies Inc., of Montreal, said it is selling its 37 percent investment in Celmed BioSciences Inc., also of Montreal, for total proceeds of up to $8.4 million. The stake will be acquired by a group of minority Celmed shareholders. The proceeds comprise an up-front cash payment of $2.8 million and future milestone payments related to the success of Celmed's products. Theratechnologies said the move will allow it to focus on developing its therapeutic peptides in endocrinology and metabolism, including its lead program, TH9507, in Phase III studies targeting HIV-associated lipodystrophy.

• Transgenomic Inc., of Omaha, Neb., said results of a study demonstrating the ability of its WAVE System to enable detection of mutations in the BCR-ABL gene that are associated with development of resistance to imatinib therapy in chronic myeloid leukemia patients were published in the June 20, 2005, issue of the Journal of Clinical Oncology. In three of 19 patients harboring BCR-ABL mutations, those mutations were detectable one to two months from the onset of therapy using the system but were not detectable by using direct DNA sequencing.

• Vesta Therapeutics Inc., of Durham, N.C., was awarded a Phase I Small Business Innovation Research grant from the National Institutes of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health. The grant will support exploring the use of adipose-derived adult stem (ADAS) cells as a therapeutic modality in liver disease. A Phase I study aims at evaluating the in vitro ability of human ADAS cells to express hepatocytes or hepatic biliary cell differentiation markers in conjunction with the expression of cytokines associated with liver regeneration.

• Viragen Inc., of Plantation, Fla., said its natural human alpha interferon, Multiferon, received approval for sale in Chile. Pentafarma SA, of Santiago, Chile, holds exclusive rights to distribute the drug in Chile.

• ViroPharma Inc., of Exton, Pa., said it will exercise its right to automatically convert $18.75 million principal amount of its 6 percent convertible senior notes due October 2009 into 7.5 million shares of common stock. The company also announced the purchase of an additional $12.2 million of its outstanding 6 percent convertible subordinated notes due March 2007 for $11.9 million, which will reduce the aggregate principal amount of the outstanding 2007 notes to $86.7 million.

• ZymoGenetics Inc., of Seattle, said findings from two trials of rhThrombin (recombinant human thrombin) in patients undergoing either arteriovenous grafting surgery for hemodialysis access or peripheral artery bypass surgery showed that the product appeared safe and well tolerated. Data also demonstrated that 90 percent of rhThrombin-treated bleeding sites achieved hemostasis by 10 minutes, compared to 74 percent with placebo. One of 37 exposed patients produced detectable antibodies to the product. Those results were presented at the Peripheral Vascular Surgery Society Spring meeting in Chicago. In other news, ZymoGenetics filed a shelf registration statement with the SEC to allow the company, from time to time, to sell up to $200 million of common stock.