• Adherex Technologies Inc., of Research Triangle Park, N.C., said that it received regulatory approval from Swiss Medic to initiate a Phase Ib/II trial of its lead angiolytic compound, Exherin, in advanced cancer patients who express the tumor molecular target N-cadherin. The study is the first in which the company will explore weekly dosing.

• AEterna Zentaris Inc., of Quebec City, initiated a company-sponsored Phase I study for its targeted cancer agent, AN-152, a cytotoxic conjugate that has the potential to selectively and specifically target certain types of cancer cells that express luteinizing hormone-releasing hormone receptors and thereby might offer a better safety and efficacy profile compared to the cytotoxic agent alone, AEterna said. AN-152 is designed to achieve differential delivery, or targeting, of the cytotoxic agent to cancer vs. normal cells.

• Affymetrix Inc., of Santa Clara, Calif., plans to make available in 2005 eight new GeneChip plant- and animal- genome arrays, including canine, Rhesus macaque, Medicago trancatula, Brassica, tomato, citrus, poplar and sugar cane.

• Albany Molecular Research Inc., of Albany, N.Y., established a wholly owned subsidiary, Albany Molecular Research Singapore Research Centre Pte. Ltd., and operations should commence in Singapore this quarter. The subsidiary will provide a range of fee-for-service chemistry technologies, including medicinal and combinatorial chemistry, process research and scale-up chemistry, analytical services and cGMP manufacture of active pharmaceutical ingredients.

• Alteon Inc., of Parsippany, N.J., initiated a Phase II trial of its A.G.E. Crosslink Breaker compound alagebrium chloride (formerly known as ALT-711) in erectile dysfunction. EMERALD (Evaluation of Alagebrium in Erectile Dysfunction in Diabetic Males on PDE5 Inhibitors) will assess the drugs' ability to restore erectile function in diabetic patients with moderate to severe ED who achieve limited benefit from current treatment with phosphodiesterase type-5 inhibitors. The trial will enroll about 40 patients, ages 18 to 70, who will receive oral doses of either alagebrium (200 mg daily) or placebo tablets for a 16-week period in conjunction with PDE5 inhibitors.

• Amarillo Biosciences Inc., of Amarillo, Texas, published review papers to prompt international discussion of low-dose interferon lozenges as a therapy for diseases such as influenza. The review, titled "Systemic effects of interferons after oral administration in animals and humans," published in the January 2005 edition of American Journal of Veterinary Research, contains 200 citations of reports of the systemic beneficial action of orally delivered interferon in dogs, cats, horses, swine, cattle, poultry, rats, mice, guinea pigs and humans.

• Amylin Pharmaceuticals Inc., of San Diego, filed a preliminary prospectus supplement to its shelf registration statement with the SEC for a proposed public offering of 6.5 million shares. The company also is granting the underwriters an overallotment option for an additional 975,000 shares. Underwriters include Morgan Stanley & Co. as sole book runner and joint lead manager, Goldman, Sachs & Co. as joint lead manager, and Banc of America Securities LLC, JPMorgan Securities Inc. and Wachovia Capital Markets LLC as co-managers.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Boston Scientific Corp., of Natick, Mass., launched its Taxus Liberte paclitaxel-eluting coronary stent system in 18 countries. Boston Scientific also announced enrollment in the ATLAS trial for U.S. testing of the Taxus system.

• Avexa Ltd., of Melbourne, Australia, licensed the HIV compound, SPD754, from Shire Pharmaceuticals Group plc, of Basingstoke, UK, which is divesting products to focus on later-stage drugs for central nervous system, gastrointestinal and renal diseases. Avexa takes on full responsibility for the worldwide development of the product, which is in Phase II and has an anticipated launch target of 2009. Avexa has the right to commercialize SPD754 everywhere except North America, where Shire retains rights. Terms include an undisclosed reciprocal royalty and a A$2 million (US$1.5 million) equity position in Avexa. Shire would have an option to acquire 4 million more shares following the successful completion of the Phase IIb trial.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reached its enrollment target of more than 450 women in the company's pivotal Phase III trial to evaluate the safety and efficacy of Bio-E-Gel for the treatment of moderate to severe hot flashes in menopausal women. Bio-E-Gel is a gel formulation of estradiol designed to be quickly absorbed through the skin after topical application on the arms, shoulders, thighs or abdomen.

• Cambrex Corp., of East Rutherford, N.J., reported that its subsidiary Cambrex Bio Science Wokingham Ltd. signed an agreement for the purchase of conditionally immortalized cell lines, related intellectual property and equipment from Xcellsyz Ltd., of Newcastle Upon Tyne, UK. Cambrex Bio Science Walkersville Inc., also a subsidiary of Cambrex, entered license agreements for Menlo Park, Calif.-based Geron Corp.'s telomerase technology and complementary conditional immortalization technology from the Ludwig Institute for Cancer Research. Detailed financial terms of the agreements were not disclosed.

• ChemDiv Inc., of San Diego, agreed to collaborate with the University of Maryland Greenebaum Cancer Center in Baltimore to focus on drug discovery to treat breast cancer. UMGCC will have access to ChemDiv's compound libraries and computational chemistry technologies, and ChemDiv will provide medicinal chemistry services. Financial terms were not disclosed.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, completed the private placement of 2.2 million units at 48 cents per share for total gross proceeds of about $1.1 million, which will be used to fund the ongoing development of the company's cellular-engineering and cell-therapy programs. Each unit consists of one common share and one-half of one common share purchase warrant. A whole warrant will entitle the holder to purchase one additional common share at 60 cents each for a period of 24 months from the placement's closing date.

• Exelixis Inc., of South San Francisco, filed a registration statement with the SEC to register for resale previously issued shares of common stock. As previously reported, Exelixis issued about 2.6 million shares of common stock in a private placement on Oct. 18 in connection with its acquisition of X-Ceptor Therapeutics Inc., of San Diego. At that time, Exelixis agreed to register the shares of common stock for resale for the benefit of former stockholders of X-Ceptor. Exelixis will not receive any of the proceeds. (See BioWorld Today, Sept. 29, 2004.)

• F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said that the European Commission approved Avastin, the new anti-angiogenic drug, for the treatment of patients with previously untreated metastatic colorectal cancer. Roche will make Avastin available across Europe within the next few weeks and expects it to be accessible to physicians and patients early in the year. Avastin is approved for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acidironotecan.

• Lorus Therapeutics Inc., of Toronto, closed the second tranche of a $15 million private placement of a convertible debenture financing on Jan. 14. The company said proceeds will be used to finance research and development, as well as ongoing operations. Lorus said 2 million warrants were placed in escrow upon the first tranche's closing, and the company released 1 million to the Erin Mills Investment Corp. to close the second tranche. The remaining 1 million will be released from escrow upon completion of a third tranche.

• Meridian Bioscience Inc., of Cincinnati, said it completed its call for the redemption of $4 million in outstanding 7 percent convertible subordinated debentures due Sept. 1, 2006. The result was that $3.4 million was converted into 211,000 shares of the company's underlying common stock and $603,000 was redeemed at par value plus accrued interest for cash.

• Novogen Ltd., of Sydney, Australia, received a milestone royalty payment of $863,000 under a license agreement with St. Louis-based Solae LLC, a joint venture between DuPont's Protein Technologies International and Bunge Ltd. The companies entered their agreement in November 1997, which gives Solae worldwide rights outside of Australia and New Zealand to certain Novogen soy isoflavone technology. Under the agreement, Solae makes regular milestone payments and pays royalties on sales of its products covered by the Novogen patents.

• PPD Inc., of Wilmington, N.C., agreed to acquire biomarker assets from Menlo Park, Calif.-based SurroMed Inc. In exchange, PPD will surrender its shares of SurroMed stock, assume $3.4 million in liabilities under the capital lease and guarantee repayment of a portion of SurroMed's bank loan up to $1.5 million. PPD said it acquired shares of SurroMed in 2002 and 2003 in exchange for $29 million in consideration consisting of cash, tangible assets and intellectual property, and now expects to see an after-tax gain of $1.5 million to $3 million.

• Procyon Biopharma Inc., of Montreal, said the primary efficacy endpoint for its North American Phase IIb trial of its topical scar treatment, Fibrostat, was not reached, as results showed no significant improvement with the drug compared to placebo-treated groups. However, the company said Fibrostat appeared safe and well tolerated and has potential for efficacy against more severe scars. A final report on the data will be available in March.

• Pro-Pharmaceuticals Inc., of Newton, Mass., completed the enrollment of patients in a Phase I trial to evaluate Davanat alone and in combination with 5-fluorouracil in refractory patients with solid tumors. Phase I data of the first 26 patients enrolled will be presented Jan. 29 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in Hollywood, Fla. The trial will evaluate a total of 40 patients.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., will initiate in the second quarter a second Phase II trial to test its drug, Thymosin beta 4, for the treatment of venous stasis ulcers. The trial will test several dosages of TB4 in patients with venous stasis ulcers in Italy and at least one other European country. The study should be completed and analyzed within about one year from enrollment of the first patient, the company said.

• Washington University School of Medicine in St. Louis said a class of anti-seizure medications seems to slow the rate of aging in roundworms and allowed the worms to retain youthful functions longer than normal. Researchers grew the roundworm C. elegans in the presence of 19 drugs and reported that an anticonvulsant, ethosuximide, extended the worms' lives by an average of 17 to 20 days. Further tests revealed an increased life span, with the drug trimethadione having the largest effect and extending the worms' lives by 47 percent. Findings are reported in the Jan. 14, 2005, issue of Science.

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