• Aastrom Biosciences Inc., of Ann Arbor, Mich., said interim results from a feasibility trial of its Tissue Repair Cells (TRCs) for maxillary bone reconstruction demonstrated clinical safety in five patients to support placement of dental implants. Data also showed that the TRC treatment sites all exhibited bone growth that was statistically significant, with the desired initial integration with preexisting bone. Aastrom is implementing a proof-of-concept clinical plan to evaluate the ability of TRCs to generate three different types of bone: long bone, jaw bone and spine.

• Acusphere Inc., of Watertown, Mass., has enrolled 700 patients in its pivotal Phase III program for AI-700, a cardiovascular drug designed to enable ultrasound to compete more effectively with nuclear stress testing for detecting coronary heart disease. The company also asked sites for one of its two concurrent pivotal trials to suspend further patient enrollment because it believes a sufficient number have been recruited for statistical significance.

• Adherex Technologies Inc., of Research Triangle Park, N.C., received orphan drug designation for eniluracil from the FDA. The designation was granted for the use of eniluracil in combination with fluoropyrimidines for the treatment of hepatocellular cancer.

• BioDiem Ltd., of Melbourne, Australia, received regulatory approval to begin a Phase I/II trial of its peptide BDM-E in patients with diabetic macula edema. BDM-E is a synthetic peptide that has been shown in preclinical studies to stimulate growth of new retinal pigmented epithelial cells and inhibit the growth of choroidal endothelial cells. The 192-patient study will evaluate the product's safety, tolerability and efficacy when administered by subcutaneous injections, compared to placebo. In separate news, BioDiem was awarded about $2.1 million via a grant from AusIndustry to accelerate the development of BDM-I, a non-antibiotic, antimicrobial product being developed to enhance growth and feed conversion in chickens, as a potential substitute for the prophylactic use of antibiotics in animal feed.

• Bioenvision Ltd., of Edinburgh, UK, said it will go before the Committee for Medicinal Products for Human Use the week of Feb. 20 in relation to the European marketing authorization application for clofarabine in the treatment of patients (up to 21 years old at initial diagnosis) with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. The committee then is expected to make a recommendation on the application and issue a formal opinion in March. Clofarabine, a next-generation purine nucleoside analogue, won FDA approval late last year to treat ALL in children and is marketed in the U.S. by Bioenvision's North American partner, Genzyme Corp., of Cambridge, Mass.

• Biopure Corp., of Cambridge, Mass., priced an underwritten public offering of common stock and warrants. Subject to closing conditions, the underwriters have agreed to purchase 8.8 million new shares of Biopure common stock and warrants to acquire an additional 8.8 million new shares. The price for one share and one warrant is 68 cents, and the exercise price of each warrant is 85 cents. The transaction is expected to close on or about Dec. 27, resulting in net proceeds to Biopure of about $5 million assuming no exercise of the warrants issued in the offering. Biopure granted the underwriters a 30-day option to purchase an additional 1.3 million shares and 1.3 million warrants to cover overallotments.

• BioTime Inc., of Emeryville, Calif., entered an addendum to its agreement with Summit Pharmaceuticals International Corp., a subsidiary of Sumitomo Corp., of Tokyo, to develop Hextend and PentaLyte for the Japanese market. The addendum grants Summit the licenses required to permit Summit to implement an agreement with Maruishi Pharmaceutical Co. Ltd., of Osaka, Japan, to seek regulatory approval and to manufacture and market Hextend in Japan. Summit also will participate in the regulatory approval process and will have the option to market and manufacture Hextend in Japan if approval is obtained.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., completed a Phase Ib trial of its leading drug candidate, CH-1504, an oral, metabolically inert, anti-inflammatory and antitumor agent aimed at treating rheumatoid arthritis, psoriasis, inflammatory bowel disease and certain cancers. Data from the trial demonstrated that the drug is safe and well-tolerated at all evaluated doses, with no clinically significant abnormalities observed. Further results will be available in the first quarter of 2006.

• Clinical Therapeutics Inc., of Lexington, Mass., initiated two definitive pharmacokinetic studies comparing the bioavailability of zileuton controlled-release tablets and zileuton immediate-release tablets in health volunteers. The first study will involve 24 volunteers; the second study will be conducted in 30 volunteers.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., is raising $29 million through the sale of 2.9 million shares of common stock to institutional and other investors at $10 per share. The transaction will close in two tranches, with the second tranche closing in January. CollaGenex expects net proceeds to support research and development, manufacturing, clinical trials, potential acquisitions and other general corporate purposes. The company develops dermatology products. Roth Capital Partners LLC is acting as placement agent in connection with the offering, and Robinson Humphrey Capital Markets acted as financial adviser.

• Crucell NV, of Leiden, the Netherlands, and allied contract manufacturer DSM Biologics, of Groningen, the Netherlands, signed a second PER.C6 commercial license agreement with Ferring Pharmaceuticals, of Suffern, N.Y. The agreement allows Ferring to use the PER.C6 cell line in the production of a specific therapeutic protein, to be applied to women's health care. Separately, Crucell and DSM signed PER.C6 research license agreement with ZyStor Therapeutics Inc., of Milwaukee, Wis. The agreement allows ZyStor to evaluate the PER.C6 cell line for use in the manufacturing of a specific therapeutic protein. Financial details also were not disclosed.

• CytoGenix Inc., of Houston, said a lawsuit brought against the company, its officer and one director by the U.S. Virgin Islands firm of Phanuel Pursuits LLC has been vacated and dismissed by the District Court of Harris County, Texas 334th Judicial District. The court granted summary judgment motions in favor of CytoGenix and against Phanuel Pursuit's cause of action. Phanuel Pursuits was demanding more than $500 million in damages claiming breach of option contracts calling for it to obtain regulatory approval for the distribution of CytoGenix's herpes product in India and in China.

• Depomed Inc., of Menlo Park, Calif., filed with the SEC a shelf registration statement which to permit Depomed to offer and sell up to $100 million of debt or equity securities. Depomed is using its AcuForm drug delivery technology to develop oral products.

• Halozyme Therapeutics Inc., of San Diego, said that Kenneth Kelley, a member of Halozyme's board since May 2004, was named chairman. Kelley succeeds Jonathan Lim, Halozyme's president and CEO, who remains a director on the board. Previously, Kelley was a general partner at Latterell Venture Partners. Kelley founded and led IntraBiotics Pharmaceuticals as CEO, director and chairman. Halozyme is dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology and oncology communities.

• Hybrigenics SA, of Paris, said that Genethon, a French gene and cell therapy research and application center, will use the company's Yeast Two-Hybrid Screening platform and its Protein Interaction Mapping software in a research program into muscle cell proteins and their interaction to develop therapeutic leads. Financial terms were not disclosed, but data obtained under the collaboration will be fully owned by Genethon.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, plans to proceed with its Phase IIb study in the first quarter of IPL512,602, an oral, once-daily anti-inflammatory medication for asthma. The trial will involve patients with moderate to severe asthma who are taking inhaled steroids but still suffering from significant symptoms requiring short-acting bronchodilators. IPL512,602 will be added to their treatment to determine if it improves asthma control. Results are expected in the first quarter of 2007.

• LifeSpan BioSciences Inc., of Seattle, entered a multiyear agreement with New York-based Pfizer Inc., which will gain access to all features of the DrugTarget Database, including informatics on more than 3,200 genes, 852 immunohistochemistry reports with localization information on more than 400 potential drug targets, and search and sort tools. Pfizer will nominate at least 60 new targets to be studied, while LifeSpan will continue to build the database.

• Maxim Pharmaceuticals Inc., of San Diego, said a majority of its shareholders approved the company's proposed acquisition by EpiCept Corp., of Englewood Cliffs, N.J., initially announced in September. EpiCept's stockholders previously approved the merger, in which EpiCept will issue shares of its common stock to Maxim stockholders in exchange for all of Maxim's outstanding shares. Upon the close of the merger, expected in January, Maxim will become a wholly owned subsidiary of EpiCept. The transaction is valued at about $136 million. (See BioWorld Today, Sept. 7, 2005.)

• MGI Pharma Inc., of Minneapolis, said top-line results from a randomized, double-blind, multicenter Phase II dose-ranging study of Aquavan (fospropofol disodium) injection in patients undergoing colonoscopy show that the 6.5 mg/kg and 8 mg/kg doses were statistically superior to the 2 mg/kg or 5 mg/kg bolus doses with regard to the sedation success endpoint. Patients treated with Aquavan injection required fewer supplemental doses to achieve initial sedation compared to those who received midazolam. The company plans to begin a pivotal program in early 2006.

• Neoprobe Corp., of Dublin, Ohio, said it submitted results from seven nonclinical studies of Lymphoseek for FDA review prior to starting a Phase II study in humans. Lymphoseek is being developed as a lymphatic tissue-targeting agent designed to improve the ability of physicians to indicate the spread of cancers, including breast, melanoma, prostate, gastric, and colon.

• Osiris Therapeutics Inc., of Baltimore, received orphan drug designation for Prochymal, an adult stem cell product under investigation for acute graft-vs.-host disease. Prochymal, which received fast-track status earlier this year, is in two Phase II trials for severe GVHD. The company also began a Phase II study of the product in Crohn's disease.

• OxiGene Inc., of Waltham, Mass., completed its recent public offering of 7.5 million shares of its common stock at $3.65 per share, plus the full overallotment option of 975,000 shares, to pull in gross proceeds of about $27.3 million. Funds will be used for general corporate purposes. At the completion of the offering, OxiGene had about 28 million shares outstanding. (See BioWorld Today, Dec. 16, 2005.)

• Prestwick Pharmaceuticals Inc., of Washington, withdrew its initial public offering, citing market conditions. The company had filed for an IPO in April, planning to raise an estimated $74.8 million to help fund the potential launch of its dopamine depletor, tretrabenazine, for chorea associated with Huntington's disease. A new drug application has been submitted to the FDA. (See BioWorld Today, April 26, 2005.)

• ProMetic Life Sciences Inc., of Montreal, intends to enter a securities purchase agreement for a private placement of senior secured convertible notes with U.S.-based institutional investors for aggregate proceeds of $8.9 million. Funds will be used for general corporate purposes. The financing is expected to close today. ProMetic develops its Mimetic Ligand technology for large-scale purification of biologics and the elimination of pathogens, and the company also focuses on development therapeutics to treat inflammation and cancer.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said data from its Phase II hepatocellular carcinoma trial indicated a trend toward positive survival benefit in patients treated with Zadaxin plus trans-arterial chemo-embolization (TACE) compared with patients treated with TACE alone. A median survival of 994 days was observed for the 12 patients who received Zadaxin plus TACE, compared with a median survival of only 399 days for the 13 patients who received TACE alone. No difference was observed in tumor response between the treatment groups.

• Sinovac Biotech Ltd., of Beijing, initiated clinical trials for its pandemic flu (H5N1) vaccine Panflu and has administered the vaccine to the first six volunteers. The Chinese regulatory agency approved a fast-track process for Panflu's clinical program, cutting the required evaluations from three to two phases. The first phase involves 120 healthy volunteers, ages 18 to 60, and is expected to take nine months, with preliminary results available around the end of March.

• Sirna Therapeutics Inc., of San Francisco, selected Sirna-AV34, a systemically delivered, chemically modified short-interfering RNA compound, as its candidate to advance into clinical testing for hepatitis C. Sirna completed its preclinical evaluation of the efficacy of Sirna-AV34 and began cGMP manufacturing for its Phase I studies. Sirna expects to initiate investigational new drug application-enabling toxicology studies in the first quarter of 2006 followed by the filing of an IND with the FDA by the fourth quarter.

• Solazyme Inc., of Menlo Park, Calif., completed an undisclosed financing round, led by the Roda Group, of Berkeley, Calif. The company uses algae to manufacture bioactive compounds for treating diabetes, heart disease, cancer and other indications. Solazyme also appointed Michael Arbige, senior vice president of technology at Palo Alto, Calif.-based Genencor International Inc., to its board.

• Theravance Inc., of South San Francisco, said preclinical data of telavancin presented at the 45th annual Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in Washington showed the compound had the most potent and consistent in vitro activity among several antibiotics, including vancomycin, linezolid, quinupristin/dalfopristin, imipenem, piperacillin/tazobactam and levofloxacin. Phase II data of telavancin in complicated Gram-positive skin and skin-structure infections demonstrated cure rates of 96 percent in a subset of patients with Staphylococcus aureus, compared with 90 percent for standard therapy. The most common adverse events for patients receiving telavancin were nausea, taste disturbance and insomnia.

• Vaso Active Pharmaceuticals Inc., of Danvers, Mass., said Judge Reginald Lindsay of the U.S. District Court for the District of Massachusetts granted final approval of the consolidated class-action settlement and the Massachusetts derivative action settlement entered in September by Vaso Active and certain officers and directors. Under terms of the settlement, Vaso Active will be paid $1.1 million by its insurance carrier and will issue $750,000 in two-year 5 percent subordinated callable notes convertible at $1.75 per share. Under terms of the derivative action settlement, Vaso Active will pay $25,000 in cash and $110,000 in two-year 5 percent subordinated callable notes convertible at $1.75 per share.