• Advanced Magnetics Inc., of Cambridge, Mass., said its European partner, Guerbet SA, of Roissy, France, submitted a marketing authorization application in Europe for Combidex, an imaging agent for use in conjunction with magnetic resonance imaging to aid in the differentiation of normal from metastatic lymph nodes. The MAA is seeking the approval of Combidex under the trade name Sinerem as an aid in diagnosing pelvic cancers, including prostate, bladder and uterus cancer.

• ArQule Inc., of Woburn, Mass., initiated a Phase I trial of ARQ 171 to evaluate the compound in patients with advanced solid tumors. In addition, the company has completed three Phase II trials with ARQ-501, a compound that can be used as monotherapy in leiomyosarcoma and head and neck cancer, or as combination therapy with gemcitabine in pancreatic cancer. Data from the ARQ 171 trial, together with Phase II data from the ongoing ARQ 501 program, will form the basis of a future licensing decision by Hoffmann-La Roche Inc., of Nutley, N.J. In other ArQule news, the company has completed a Phase I trial for ARQ 196, a proprietary orally administered small-molecule inhibitor of the c-Met receptor tyrosine kinase.

• Avicena Group Inc., of Palo Alto, Calif., signed an agreement with the National Institute of Neurological Disorders and Stroke to supply PD-02, its lead Parkinson's disease drug candidate, for a Phase III trial. It is designed to evaluate PD-02's potential to slow the progression of the disease. Avicena will provide PD-02 and placebo for the trial and fund a chronic toxicology study, while gaining the right to use the study's findings for a new drug application submission to the FDA.

• Avigen Inc., of Alameda, Calif., has completed a Phase I trial for AV650, an oral therapy intended for disabling neuromuscular spasticity and spasm. The double-blind study enrolled 30 healthy adults to evaluate the safety, tolerability and pharmacokinetics of AV650. The chemical was found to be well tolerated in patients. AV650 is being developed in the North American market under a license and supply agreement with Sanochemia Pharmazeutika AG of Vienna.

• Cambridge Biostability Ltd., of Cambridge, UK, and Panacea Biotec Ltd., the second largest vaccine producer in India, entered a joint venture agreement. Panacea Biotec has taken a 10 percent stake in Cambridge Biostability, for a total consideration of £1.9 million (US$3.7 million). Also, Rajesh Jain, joint managing director of Panacea Biotec, has been appointed to the board of CBL as nonexecutive director. Cambridge Biostability also has signed a long-term licensing agreement in which it will in-license CBL's stable liquid technology to develop, produce and market a stable liquid version of pentavalent and other combination vaccines for the treatment of diphtheria, tetanus, pertussis (whooping cough), hepatitis B and haemophilus influenza B (a major cause of bacterial meningitis and pneumonia in children).

• Cerus Corp., of Concord, Calif., entered agreements with selected institutional investors to sell 3.9 million shares of its common stock at $6.68 per share. The net proceeds to Cerus are expected to be about $24.3 million after deducting placement agency fees and estimated offering expenses. Banc of America Securities LLC acted as lead placement agent for the offering and Robert W. Baird & Co. Incorporated acted as co-placement agent. All of the shares are being offered by Cerus under an effective shelf registration statement.

• ImaRx Therapeutics Inc., of Tucson, Ariz., withdrew its filing for an initial public offering, citing unfavorable market conditions. The company filed to go public in May, anticipating the sale of 5 million shares priced between $10 and $12. Funds would have been used to support ongoing development of clot-dissolving drugs, which are designed as variants of urokinase, in ischemic stroke and other vascular disorders. (See BioWorld Today, May 23, 2006.)

• MediciNova Inc., of San Diego, which is publicly traded on the Hercules Market of the Osaka Securities Exchange, said the Nasdaq Stock Market has approved its application for listing securities on The Nasdaq Global Market. MediciNova expects to commence trading today under the symbol "MNOV." MediciNova is focused on accelerating the global development and commercialization of innovative pharmaceutical products.

• Migenix Inc., of Vancouver, British Columbia, closed its previously announced offering, on a bought-deal basis, of units at a price of C$0.60 (US$0.52) per unit. The 15 percent underwriter overallotment option was exercised in full resulting in the issuance of a total of 19.3 million units for gross proceeds of about $11.6 million. The units comprise 19.3 million common shares and warrants for the purchase of another 9.6 million common shares at a price of C$0.80 per common share exercisable on or before Dec. 6, 2011. Additionally the underwriter received warrants for the purchase of 963,125 units at a price of $0.60 exercisable on or before Dec. 6, 2008. Following the issuance of the units, there are 93.9 million common shares issued and outstanding.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said results from a placebo-controlled, crossover Phase I study of its insulin nasal spray formulations, NovoLog insulin aspart (rDNA origin) injection and Exubera (insulin human [rDNA origin]) inhalation powder in healthy subjects showed that three nasal doses had time to maximum plasma level for insulin (Tmax) of 16 to 19 minutes and were the fastest compared to the rapid-acting insulin aspart and inhaled insulin. With respect to plasma insulin levels, rapid-acting insulin aspart injection had the highest concentration, followed by the three nasal formulations, with inhaled insulin having the lowest. The trial involved 12 subjects.

• Osteologix, of San Francisco, initiated a double-blind, placebo-controlled Phase II trial of NB S101, its investigational drug for osteoporosis. The company will enroll 276 premenopausal women with low mineral bone density for a 12-week study. The trial will evaluate any change in the patients' bone resorption, as well as the effect of NB S101 on bone formation, bone mineral density, strontium levels and cartilage degradation. Side effects also will be assessed.

• Scynexis Inc., of Research Triangle Park, N.C., entered a multiyear research agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to discover and develop oncology compounds. Scynexis will produce highly targeted compound libraries and rapid lead optimization techniques to develop new drug candidates for clinical evaluation.

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