• Aastrom Biosciences Inc., of Ann Arbor, Mich., expanded the U.S. Phase I/II trial of its Tissue Repair Cells (TRCs) for the treatment of severe long bone non-union fractures to include the Department of Orthopedic Surgery at William Beaumont Hospital in Royal Oak, Mich. The other two sites involved in the trial are Lutheran General Hospital in Chicago and the University of Michigan Health System in Ann Arbor. TRCs are Aastrom's mixture of bone marrow stem and progenitor cells produced using single-pass perfusion technology with the AastromReplicell System.

• Acusphere Inc., of Watertown, Mass., said its AI-700 Phase III pilot study exceeded prespecified endpoints. The pilot phase focused on training and qualifying clinical sites and blinded readers, and the company reported that all six of its independent blinded readers were able to read a subset of ultrasound images. AI-700 is a cardiovascular drug aimed at assessing coronary heart disease. Acusphere said it expects to complete enrollment during the second half of 2005.

• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., said its board appointed Richard Burgoon CEO effective Jan. 5. He replaced James Crapo, who served in the position under a six-month contract that expired Dec. 31. Burgoon co-founded Allon Therapeutics Inc. and GenSpera Inc. and worked for Arena Pharmaceuticals Inc., Cephalon Inc. and IDEC Pharmaceuticals Inc.

• AEterna Zentaris Inc., of Quebec City, closed its acquisition of all issued and outstanding shares of privately held Echelon Biosciences Inc., of Salt Lake City. At closing, AEterna paid $2.7 million through the issuance of 443,905 common shares at $6.11 apiece, and the transaction cost could reach up to $5.6 million. The residual amount will be payable upon reaching pre-defined development and commercial milestones through the issuance of additional shares over a period of up to three years. Simultaneously, AEterna began preclinical development of Erucylphosphocholine, or ErPC (ZEN 027), an analogue of perifosine suitable for intravenous administration. AEterna also licensed to its current North American partner for perifosine, Keryx Biopharmaceuticals Inc., of New York, certain rights to develop and market ErPC in North America, South Africa, Israel, Australia and New Zealand while keeping those rights for the rest of the world. Financial terms were not disclosed.

• Alerion Biomedical Inc., of San Diego, in collaboration with the Vanderbilt University Medical Center was awarded a Small Business Technology Transfer grant from the National Institutes of Health for a project titled "MRI with Protease-Sensing Contrast Agents." Goals include designing, synthesizing and testing a new class of biochemically activated magnetic resonance imaging contrast agents that detect and monitor disease-associated enzymatic activity in vivo.

• Allos Therapeutics Inc., of Westminster, Colo., expanded into Europe its Phase III trial of the radiation sensitizer Efaproxyn (efaproxiral) in patients with brain metastases originating from breast cancer. The trial, known as ENRICH, has a primary endpoint of median survival time and is enrolling 360 patients at more than 100 centers in the U.S., Canada, Europe and South America. Enrollment should be completed by the third quarter of 2006.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted GeneCare Research Institute Co. Ltd., of Kamakura, Japan, an exclusive license to InterfeRx to discover, develop and commercialize RNAi therapeutics directed against two DNA helicase genes associated with cancer. Terms include up-front, annual and milestone payments in cash, and potential royalties. Alnylam retains the right to negotiate co-development and co-promotion arrangements in the U.S.

• Altachem Pharma Ltd., of Edmonton, Alberta, received support from the National Research Council of Canada's Industrial Research Assistance program for development of the company's photodynamic therapy for prostate cancer. Total government assistance amounts to $445,000 and will support the preclinical development of Altachem's photosensitizer and laser-light system. Altachem's PDT therapy is based on its platform technology that uses a non-toxic derivative of photosensitizing compounds isolated from parasitic fungi on bamboo.

• AtheroGenics Inc., of Atlanta, and several of its executives were named as defendants in a class-action lawsuit alleging that they failed to disclose and misrepresented a number of facts regarding a study of AGI-1067. The suit charges that the company hyped results of an inconclusive and limited trial, that the statistically impressive levels of plaque reduction described in an initial announcement varied significantly from final results, that it manipulated results in order to enter a partnership with a major pharmaceutical company to complete AGI-1067's development and commercialization, and that the company was burning cash at a high rate. More than a month ago, AtheroGenics reported final Phase II data detailing the drug's ability to reverse atherosclerotic plaque buildup, but the findings were not as compelling as initially reported interim results. (See BioWorld Today, Sept. 29, 2004, and Nov. 23, 2004.)

• Avant Immunotherapeutics Inc., of Needham, Mass., received a $2 million milestone payment from London-based GlaxoSmithKline plc. The payment marks the acceptance for review by the European regulatory authorities of a marketing application for Rotarix rotavirus vaccine. GSK gained worldwide commercialization rights to the product in 1997.

• The Biotechnology Industry Organization in Washington said former Pennsylvania Rep. James Greenwood officially took the reins as president of the group. He succeeds the now-retired Carl Feldbaum, who served as BIO's president since its 1993 inception.

• Biolex Inc., of Pittsboro, N.C., submitted an investigational new drug application in the U.S. and a clinical trial authorization application to the Medicines and Healthcare Products Regulatory Agency in the UK for Phase I trials of BLX-883, a form of alfa interferon. It would be the first product manufactured using the company's LEX System to enter the clinic.

• ChemoCentryx Inc., of Mountain View, Calif., is conducting a Phase II trial to evaluate the safety and pharmacokinetics of one of the company's lead products, Traficet-EN (CCX282), in patients with inflammatory bowel disease. Traficet-EN is an orally bioavailable, anti-inflammatory agent that targets the chemokine receptor known as CCR9. The study will enroll 60 patients with moderate to severe Crohn's disease.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., reported results from the company's Phase Ia study in volunteers and Phase Ib dosing of hepatitis C patients with Actilon, its lead antiviral TLR therapeutic. Actilon is a first-in-class Toll-like receptor-9 agonist being developed in hepatitis C. Researchers observed an immune system response demonstrating drug-related increases in interferon-alpha levels and other markers indicative of antiviral activity. In the Phase Ib study of 18 patients evaluated to date, six have demonstrated early viral level reduction equal to or better than 1.0 log decrease during the four weeks of treatment.

• Corautus Genetics Inc., of Atlanta, said Circulation published preclinical results of the company's gene-transfer technology administered via drug-eluting stents. Data showed that VEGF-2 could be delivered to blood vessels using drug-eluting stents and that the delivery led to accelerated growth of healthy endothelial cells while reducing pathological thickening of the artery. Corautus' technology is being tested in a Phase IIb trial that is enrolling up to 404 patients with Class III or IV angina in about 25 cardiac medical centers in the U.S.

• Cytos Biotechnology AG, of Zurich, Switzerland, signed an agreement with Pfizer Inc., of New York, for the testing of Cytos' Immunodrugs for animal health applications. Terms of the deal gave Pfizer exclusive access to test two Immunodrug candidates in its models and, if a commercial license agreement is executed, exclusive development and commercial rights to them. In return, Cytos will receive an undisclosed up-front payment, as well as potential milestones and additional fees on commercial license execution, technology transfer for manufacturing, for the drug substance's supply and upon approval. If products are launched, Cytos also stands to earn royalties on Pfizer's net sales. Also, Pfizer has the first claim to negotiate for any further Immunodrug candidates in the same therapeutic area developed by Cytos for animal health.

• CytRx Corp., of Los Angeles, said scientific data published in the December issue of Cell and Molecular Life Sciences showed that iroxanadine might help to reduce damage to blood vessels that occurs when blood flow is restricted and then restored, such as during and immediately after heart attack and stroke. Researchers demonstrated that iroxanadine protects human endothelial cells that line the walls of blood vessels in an in vitro cellular model system of ischemia followed by reperfusion. Cells treated with iroxanadine showed significantly less cell death when oxygen was restored to oxygen-starved endothelial cells, even when the drug was added 20 hours after onset of oxygen deprivation.

• Discovery Laboratories Inc., of Warrington, Pa., initiated two Phase II trials using its surfactant replacement therapy to address respiratory disorders prevalent in premature infants. The trial is expected to enroll up to 210 low-birth-weight premature babies at risk of developing bronchopulmonary dysplasia. Infants will receive one of two Surfaxin treatments, and the trial will assess the safety and efficacy of the treatments to be administered in liquid form and injected through the patient's endotracheal tube.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the first patient has been dosed in a clinical trial of ATG-Fresenius S to prevent acute organ rejection in patients receiving lung transplantation. The study is comparing two different dosing regimens of ATG-Fresenius S plus the standard post-transplant triple immunosuppressive regimen to a group treated with only the standard regimen in patients undergoing lung transplantation. The primary endpoint is the occurrence of acute transplant rejection, graft loss or death within six months post-transplant.

• Gemin X Biotechnologies Inc., of Montreal, initiated a Phase I/II trial in chronic lymphocytic leukemia with GX15-070, a targeted cancer treatment designed to induce apoptosis by inhibiting the Bcl-2 family of proteins. Gemin X also said that GX15-070 was granted orphan drug status for the treatment of CLL. GX15-070 will be administered to patients with CLL who previously have been treated with an alkylating agent and fludarabine.

• Genencor International Inc., of Palo Alto, Calif., said it plans to build a new manufacturing facility in the Wuxi, China, National Hi-Tech Industrial Development Zone. Genencor also purchased the remaining about 15 percent interest in Genencor Bio-products from its joint venture partner, the Wuxi Enzyme Factory, and intends to operate the new facility as a wholly owned entity. Once completed, the company plans to transfer operations and personnel from its existing manufacturing facility in downtown Wuxi to the new facility.

• Genzyme Corp., of Cambridge, Mass., completed the transaction to buy back sales and marketing rights to Synvisc (hylan G-F 20) in the U.S. and five European countries, including Germany, Poland, Greece, Portugal and the Czech Republic, from Wyeth, of Madison, N.J. Genzyme paid Wyeth $99 million in cash for the marketing rights and will pay an additional $22 million during the first quarter upon the final transaction. Wyeth also could be in line for sales-based milestone payments extending to June 2012, or totaling $294 million, whichever comes first. Genzyme plans to release guidance related to Synvisc in its fourth-quarter earnings release on Feb. 17. Genzyme announced the purchase in November. (See BioWorld Today, Nov. 5, 2004.)

• Geron Corp., of Menlo Park, Calif., announced that the U.S. Patent and Trademark Office's Board of Patent Appeals and Interferences entered a judgment against Advanced Cell Technology Corp., of Worcester, Mass., ending patent interference between the companies. Geron claimed ACT's patent, No. 5,945,577, included nuclear transfer technology first invented at the Edinburgh, Scotland-based Roslin Institute and licensed to Geron in 1999.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., received a contract from the Environmental Protection Agency to employ its chemogenomics platform to predict the toxicity of potentially hazardous chemicals. The company's DrugMatrix data system, containing profiles of more than 650 compounds, is used to derive drug signatures. Iconix said the drug signatures will be used to profile the five compounds submitted by the EPA. The company will work with the EPA's Computational Toxicology Research Program.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., launched Vitrase in two vial sizes for use as a spreading agent to facilitate the absorption and dispersion of other injected drugs, for hypodermoclysis and as an adjunct in subcutaneous urography. Vitrase is a formulation of highly purified, preservative-free ovine hyaluronidase. Vitrase was approved by the FDA in May 2004. (See BioWorld Today, May 7, 2004.)

• Life Science Angels Inc., of Palo Alto, Calif., was launched as an angel investment group backed by 15 exclusive sponsors. LSA, formed to fund seed and early stage biotech and medical device companies, will target investments of about $250,000 to $1 million. The organization has started soliciting investment opportunities and will hold its first investment meeting in late February.

• Neurochem Inc., of Kingston, Ontario, a spin-off company of Queen's University Parteq Innovations, signed an exclusive agreement with Centocor Inc., of Malvern, Pa., for distribution rights to Fibrillex, Neurochem's product for the treatment and prevention of AA Amyloidosis. Neurochem completed Phase II/III trials of Fibrillex in December and expects to file for approval this year. The agreement gave Centocor worldwide marketing and distribution rights to Fibrillex, with the exception of Canada, Switzerland, China, Japan, Taiwan and South Korea, where marketing and distribution rights remain with Neurochem.

• Nitto Denko, of Ibaraki, Japan, developed a cross-linked polystyrene bead designed to support synthesis of oligonucleotides needed for DNA- and RNA-based gene therapies. The development was achieved in a joint venture with Carlsbad, Calif.-based Isis Pharmaceuticals Inc. The polystyrene bead design will be marketed through Nitto Denko's wholly owned U.S. subsidiary, Kinovate Life Sciences Inc., of Oceanside, Calif.

• Ortec International Inc., of New York, completed a series of equity transactions resulting in gross proceeds of about $6.4 million. Also, about $9.6 million of promissory notes issued during the past year converted into common equity. The approximate $6.4 million in gross proceeds raised includes about $1.4 million generated from a recently completed equity financing transaction. The company said the financing provides it necessary capital to continue its preparation for the commercial launch of OrCel, a bilayered cellular matrix product being developed to heal chronic and acute wounds.

• Panacos Pharmaceuticals Inc., of Gaithersburg, Md., said the FDA granted fast-track designation for the once-daily oral drug candidate PA-457 for the treatment of HIV infection. The drug has been shown to be well tolerated and it is in a Phase IIa trial initiated in December.

• Semafore Pharmaceuticals Inc., of Indianapolis, appointed Ronald Henriksen to the newly created position of CEO, as well as to the board. Currently chief investment officer of Twilight Venture Partners, a life sciences venture capital firm, Henriksen previously served as CEO of the Indiana University Advanced Research & Technology Institute, Itasca Ventures and Khepri Pharmaceuticals.

• Silicon Graphics Inc., of Mountain View, Calif., said its SGI supercomputing and storage solutions are being used for research designed to link liver-specific proteins to diseases such as hepatitis and liver cancer at the China Human Proteome Organization in Beijing. The Human Liver Proteome Project is backed by an initial round of $16 million in funding from the Chinese government for a three-year pilot study to be completed this year.

• Sinovac Biotech Ltd., of Beijing, said its securities have been listed on the Halter USX China Index, which is exclusively devoted to U.S.-listed securities of companies that derive the majority of their revenues from the People's Republic of China. Sinovac is developing human vaccines for infectious illnesses.

• Sirna Therapeutics Inc., of Boulder, Colo., said it is developing a program to apply RNA interference technology to asthma by targeting Th2 cytokines that play a critical role in inflammation and bronchconstriction in the airways. Results of preclinical animal studies that used chemically modified, systemically delivered siRNAs showed statistically significant reduction of airway hyper-responsiveness (66 percent) in the RNAi treatment group. Following additional preclinical studies, the company expects to enter human trials next year.

• Somaxon Pharmaceuticals Inc., of San Diego, said low-dose doxepin demonstrated statistically significant results in a Phase II study in adults with primary sleep-maintenance insomnia. Specifically, doxepin demonstrated a statistically significant improvement in the primary endpoint by polysomnography-defined wake time during sleep vs. placebo (3 mg, p=0.0004, and 6 mg, p=0.0025). There was no difference in adverse events or next-day residual effects with low-dose doxepin vs. placebo.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., completed enrollment in the Phase II trial of EOquin as a single agent in patients with recurrent superficial bladder cancer refractory to at least one prior treatment regimen. The primary objective of the Phase II trial is to evaluate tumor response with time to recurrence and overall safety as the secondary objective.

• Synthetic Blood International Inc., of Costa Mesa, Calif., opened patient enrollment in its first Phase II trial for Oxycyte, a perfluorocarbon blood substitute and therapeutic oxygen carrier. The company said the trial will be the first in a series to focus on surgery, trauma and indications for therapeutic oxygen and will be administered to hip surgery patients experiencing mild to moderate blood loss during surgery.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, entered an alliance to further the development and commercialization of a non-flourinated quinolone antibiotic invented by Procter & Gamble Pharmaceuticals, a unit of Procter & Gamble Co., of Cincinnati. TaiGen will be responsible for conducting Phase Ib and II development of the compound to meet worldwide regulatory standards. If Phase II results are positive, P&G, in conjunction with TaiGen, might then seek a pharmaceutical partner for the compound's Phase III development and subsequent commercialization. In addition, TaiGen gained development and commercialization rights within China, Taiwan, Korea and the ASEAN countries.

• Vela Pharmaceuticals Inc., of Ewing, N.J., reported positive results from its Phase II trial of dextofisopam for irritable bowel syndrome in which the compound provided relief in women and men with diarrhea-predominant or alternating-type IBS. Vela said some symptoms were relieved as early as the second day of treatment and the compound was well tolerated and did not result in constipation. In the 141-patient study, diarrhea-predominant and alternating-type IBS patients were randomized to 12 weeks of treatment with 200 mg of dextofisopam given twice daily or placebo. On the primary endpoint of months of adequate relief of symptoms, treated patients reported relief for 57 percent of the time vs. 43 percent for placebo-treated patients (p=0.033). Treatment effects were most robust in the first month of treatment, the company said, and the compound was superior to placebo in stool frequency and consistency, two secondary endpoints.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Merck & Co. Inc., of Whitehouse Station, N.J., began a Phase I study of the aurora kinase inhibitor VX-680 in patients with solid-tumor cancers. The study is designed to evaluate safety and tolerability when administered in multiple cycles to patients with solid tumors refractory to prior chemotherapy treatment. Vertex and Merck entered their collaboration to develop and commercialize VX-680 in June. (See BioWorld Today, June 23, 2004.)

• ViroPharma Inc., of Exton, Pa., said its partner, Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, submitted an investigational new drug application to evaluate ViroPharma's HCV-796, a polymerase inhibitor, to treat hepatitis C. With two HCV compounds in development, ViroPharma expects to begin dosing patients in the HCV-796 trial later in the quarter and to initiate proof-of-concept studies during the second quarter.

• VirtualScopics LLC, of Rochester, N.Y., said an affiliate of New York-based Loeb Partners Corp. exercised 100 percent of the warrants received in the initial investment in VirtualScopics. The company said proceeds of $1.4 million are expected to be used to increase sales and marketing efforts as well as continuing development of products. The funds bring the company's cash position at year-end to about $3.5 million. VirtualScopics provides imaging solutions using biomarkers for pharmaceutical development.

• XenoPort Inc., of Santa Clara, Calif., said results from its Phase IIa trial of XP13512, designed to treat restless legs syndrome, showed clinically relevant benefits. The company reported that the trial, involving 38 patients, showed statistical improvement in objective sleep measures with XP13512, compared to placebo. XenoPort also said 29 patients reported themselves "much improved," compared to five patients at the end of the placebo treatment period.

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