• Adventrx Pharmaceuticals Inc., of San Diego, said that the primary endpoint of response rate was met in its Phase II study to evaluate the safety and efficacy of weekly treatment with CoFactor and 5-fluorouracil in patients with metastatic colorectal carcinoma. CoFactor is a biomodulator developed to enhance the activity of 5-fluorouracil.

• Agilent Technologies Inc., of Palo Alto, Calif., introduced its whole rat genome oligonucleotide microarray, which the company said provides broad genome coverage, validated genomic content and sensitivity needed to assess the effects of environmental toxins or drug interactions on cells.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said nine-month results from its TAXUS V trial confirmed the safety and efficacy of the Taxus Express2 paclitaxel-eluting coronary stent system for the treatment of coronary artery disease. The trial, which enrolled 1,172 patients, met both primary and secondary endpoints, showing a significantly lower target vessel revascularization rate, from 15.7 percent to 8.6 percent in Taxus patients after nine months vs. the control group patients, as well as reduced in-stent binary restenosis rates. The TAXUS V trial expanded the TAXUS IV study and included high-risk patients with large vessels and long lesions requiring multiple overlapping stents. While releasing the results, Angiotech downplayed data from another trial, that one sponsored by New Brunswick, N.J.-based Johnson & Johnson, to compare J&J's Cypher stent to the Taxus stent. Results of the REALITY trial, presented March 6 at the American College of Cardiology Annual Scientific Session, reported a missed endpoint, but Angiotech called the study "biased," and said it was "not blinded to the doctor" placing the stent or analyzing the data. Angiotech's partner, Boston Scientific Corp., of Natick, Mass., acquired worldwide exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products, and also has co-exclusive rights to other vascular and non-vascular products.

• Avidex Ltd., of Oxford, UK, said it reached an agreement with Active Biotech AB, of Lund, Sweden, for the use of Avidex's monoclonal T-cell receptor (mTCR) technology to help Active Biotech develop its cancer immunotherapeutic Anyara. The agreement calls for Active Biotech to use Avidex's mTCR platform to characterize Anyara during clinical development. Financial terms were not disclosed.

• BioAlliance Pharma SA, of Paris, said data presented at the 12th Conference on Retroviruses and Opportunistic Infections in Boston suggested that styrlquinolines (SQLs), a family of integrase binding inhibitors, might offer a way to overcome HIV resistance. The company said its SQLs showed synergy with reverse transcriptase inhibitors (zidovudine and nevirapine), along with another family of integrase inhibitors known as diketoacids. An in vitro study suggested that SQLs could be used in combination with other antiretroviral drugs in multi-therapy regimens, and illustrated the potential for developing a class of alternative integrase inhibitors to prevent the development of HIV resistance.

• BioDelivery Sciences International Inc., of Newark, N.J., received confirmation from the FDA that the company will be able to use the agency's 505(n)(2) regulatory pathway for regulatory approval consideration of its licensed BEMA fentanyl formulation. As a result, BDSI said it plans to enter BEMA fentanyl into Phase III studies in the second half of 2005. BDSI is developing BEMA fentanyl for the treatment of breakthrough pain in cancer patients.

• Chiron Corp., of Emeryville, Calif., reached a settlement agreement with the Respiratory Disease Network, a group of three compounding pharmacies established by SourceCF in September. Chiron named the RDN as a defendant in litigation concerning the marketing of a compounded formulation of the antibiotic tobramycin for use in a drug delivery device. Chiron makes and markets Tobi tobramycin inhalation solution, a product approved by the FDA for use in combination with the PARI LC Plus Reusable Nebulizer and a DeVilbiss Pulmo-Aide air compressor to treat pseudomonal lung infections in cystic fibrosis patients. Under the terms of the agreement, which covers the compounding of tobramycin and the marketing of the drug delivery device, the RDN pharmacies are required to attach a disclaimer to any promotional materials related to the drug-device combination. The disclaimer must warn that compounded prescriptions are not evaluated by the FDA for safety or efficacy. The disclaimer also must warn that the device in question has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of CF patients.

• Evotec OAI AG, of Hamburg, Germany, acquired the outstanding 78 percent of Evotec Neurosciences (ENS), of Oxford, UK, for about 14.3 million new ordinary shares, or €49 million (US$64.8 million). ENS, which was founded by Evotec in May 1999, focuses on therapies for Alzheimer's disease and other central nervous system disorders. Once the acquisition is complete, Evotec should have cash resources of more than €60 million, including €27 million from an equity investment, €20 million from ENS and €15 million in existing cash.

• First Horizon Pharmaceutical Corp., of Alpharetta, Ga., is reinitiating the share repurchase program announced last year, calling for the repurchase of up to $20 million of the company's common stock, not to exceed $5 million per quarter. The company said the share repurchase program is authorized to run until July 29.

• Gene Network Sciences, of Ithaca, N.Y., signed a drug development contract with Johnson & Johnson Pharmaceutical Research & Development, a unit of New Brunswick, N.J.-based Johnson & Johnson, allowing J&J to use pathway interference technology and data-driven computer models to determine the pathways associated with the mechanism of action, biomarkers and tumor specificity of a preclinical oncology compound. Financial terms were not disclosed.

• Geron Corp., of Menlo Park, Calif., presented results from a Phase I/II trial at the 58th annual Cancer Symposium of the Society of Surgical Oncology in Atlanta. The studies showed that its small-molecule telomerase activators, GRN139951 and GRN140665, enhanced the functional activity of immune cells from HIV/AIDS donors. Specifically, the studies indicated that both GRN139951 and GRN140665 stimulated T-cell proliferation and IFN production. Preliminary data presented at the meeting also suggested that those molecules could increase the cytolytic activity of CD8+ T cells taken from a person infected with HIV.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said a study at the University of Pittsburgh showed that its synthetic cannabinoid product, IP 751, significantly reduced the bladder overactivity observed in an animal model of interstitial cystitis. IP 751 suppressed the overactivity in a dose-dependent manner, with the highest dose completely reversing the excessive bladder contractility to normal function. It did not appear to have any effect on the normal voiding mechanism of the bladder. Indevus is developing IP 751 in several indications. The compound was determined to be safe following a Phase I study and has shown effectiveness in a Phase II trial in patients with neuropathic pain.

• Life Sciences Technologies: Innovations and Opportunities in Biotechnology, Biomedical Informatics and Medical Devices conference in Buffalo, N.Y., featured Sen. Hillary Clinton, who introduced industry executives and venture capitalists to life sciences opportunities in the Buffalo/Niagara region. Greg Lucier, CEO of Carlsbad, Calif.-based Invitrogen Corp., said his company is considering further investment in the area. Other conference participants included Melville, N.Y.-based OSI Pharmaceuticals Inc. and venture capitalist firms Oxford BioSciences, Atlas Ventures, Warburg Pincus, Polaris Ventures and SR Euclid Partners.

• Marshall Edwards Inc., of Stamford, Conn., appointed a clinical research organization to manage the final stages of the clinical program of its cancer drug phenoxodiol. The CRO will manage a new trial meant to provide data for a new drug application in the U.S. and elsewhere for phenoxodiol to treat recurrent, chemorefractory ovarian cancer. The pivotal trial, called the Ovature trial, follows positive tumor responses seen in a Phase IIa study.

• Medarex Inc., of Princeton, N.J., and Bristol-Myers Squibb Co., of New York, reported results of an early clinical study with the investigational fully human anti-CTLA-4 antibody, MDX-010, in which eight of 36 patients with metastatic melanoma experienced objective clinical responses. Of the eight patients who experienced objective tumor regression, two patients in the 3-mg/kg cohort experienced complete responses that are ongoing at more than 13 months, and one patient in the 2-mg/kg cohort experienced a complete response that is ongoing at more than 16 months.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said a research team led by Suzanne de la Monte and Jack Wands of the Brown University Medical School has found evidence that impaired insulin functioning may be responsible for abnormalities found in Alzheimer's disease. The findings, published in the most recent issue of Journal of Alzheimer's Disease, reported that abnormalities in gene expression could result in impaired insulin function in the brain, including those reported with respect to neural thread protein (NTP), and could help precipitate the neurodegenerative disorder. Nymox is developing drugs to treat Alzheimer's by targeting NTP.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., published data in Clinical Cancer Research demonstrating antitumor activity in various tumor models using the murine monoclonal antibody 3G4, an equivalent of the company's Phase I product Tarvacin. The studies were performed at University of Texas Southwestern Medical Center at Dallas. The article stated that treatment with 3G4 as a monotherapy reduced the growth of tumors by up to 75 percent in established human breast tumor models, up to 90 percent in a mouse fibrosarcoma model, and 50 percent in a human Hodgkin's tumor model.

• Pluristem Life Systems Inc., of Haifa, Israel, completed private placements totaling $3.2 million, part of which was reported in January, to further its development efforts, expand the company's infrastructure and for working capital. The funds will be used to continue development of the company's stem cell-expansion technology using the PluriX bioreactor.

• Solexa Ltd., of Cambridge, UK, and Lynx Therapeutics Inc., of Hayward, Calif., completed their $56 million merger. The entity will be called Solexa Inc., with Solexa Ltd. becoming a wholly owned UK subsidiary. The company has listed on the Nasdaq SmallCap Market under the symbol "SLXA." John West will become CEO of the combined company, and Craig Taylor will serve as chairman. (See BioWorld Today, Sept. 30, 2004.)

• V.I. Technologies Inc., of Watertown, Mass., said it received a "going concern" qualification in its audit report filed with the SEC. The qualification was based on the cash balance of the company as of Dec. 31, which was not sufficient to fund operations over the next year. The company said in December that it had signed an agreement with a group of investors for a $20 million private placement of common stock and warrants, but the financing is subject to shareholder approval and to the closing of the company's proposed merger with Panacos Pharmaceuticals Inc., of Gaithersburg, Md. (See BioWorld Today, June 4, 2004.)

• ViroPharma Inc., of Exton, Pa., said data from its Phase I trial of maribavir, a cytomegalovirus compound, demonstrate that the product is well tolerated, shows antiviral activity and does not appear to induce CYP3A, an enzyme that metabolizes a large number of drugs used by transplant patients. Results were presented during the 2005 American Society for Clinical Pharmacology and Therapeutics annual meeting in Orlando, Fla. Maribavir is in a Phase II study in allogeneic stem cell transplant patients, and the company anticipates beginning a Phase III study during the first quarter of 2006.

• Zonagen Inc., of The Woodlands, Texas, said the U.S. Patent and Trademark Office issued a second and final rejection of all claims in the re-examination proceedings of U.S. Patent No. 6,391,920, which is related to a method of treating testosterone deficiency in men using an anti-estrogen, such as clomiphene. The owner of the patent can respond to the final rejection by April 25 and could appeal the decision. Zonagen has six pending patent applications in the U.S. for its testosterone deficiency product Androxal.