• Abiogen Pharma, of Pisa, Italy, started a Phase II trial of its anti-anxiety drug, ABIO 08-01, in Vienna, Austria, in patients that have generalized anxiety disorder. The pharmacological efficacy of ABIO 08-01 in several animal models showed that the molecule was active after a single oral administration. Two Phase I studies showed a good profile of safety and tolerability.

• Allergy Therapeutics plc, of Worthing, UK, concluded an end-of-Phase II meeting with the FDA for its ultra-short-course grass pollen allergy vaccine, Pollinex Quattro. Subject to minor clarifications, the FDA has accepted the company's plans to conduct a single pivotal Phase III trial.

• Cell Genesys Inc., of South San Francisco, said clinical results of GVAX immunotherapy for prostate cancer in patients with early stage disease were published in a June issue of Clinical Cancer Research. The Phase I/II trial enrolled 21 patients with rising prostate specific antigen levels following prostatectomy and who had not received any other treatment, including hormone therapy. Results showed that 76 percent (16 of 21) of patients had a statistically significant decrease in the rate of rise of PSA post-treatment, compared with the remaining five patients (p<0.001). The treatment was generally well tolerated, with self-limited injection site reactions, and mild flu-like symptoms being the most frequently reported side effects.

• DanioLabs, of Cambridge, UK, started a Phase I proof-of-concept trial of DL06001 and DL06002 for sialorrhoea (drooling) and hyperhidrosis (excessive sweating) in Parkinson's disease, respectively. They are the first of the company's programs to enter the clinic and are part of DanioLabs' focus on improving the quality of life of patients with intractable neurological conditions.

• Epeius Biotechnologies Corp., of San Marino, Calif., opened a vaccine-assisted Phase I/II trial in which patients with metastatic breast cancer that is refractory to conventional chemotherapy will introduce Reximmune-C, the second in a series of targeted biologics designed to seek out, accumulate in and destroy metastatic tumor nodules, while sparing normal cells and tissues. The lead product, Rexin-G, recently was granted orphan status.

• Favrille Inc., of San Diego, said data from its initial Phase II trial evaluating FavId as a single therapeutic agent in previously treated and relapsed patients with indolent B-cell non-Hodgkin's lymphoma have been published in the July 1 issue of the Journal of Clinical Oncology. The article concludes that FavId as a single agent is active and well tolerated in previously treated and relapsed patients. Results demonstrated a median time to disease progression for the 31 evaluable patients in the trial of 13.5 months. The most common adverse events reported were mild to moderate injection site reactions.

• Norwood Abbey Ltd., of Melbourne, Australia, said its subsidiary, Norwood Immunology Ltd., completed an 83-patient pilot exploratory study in cancer patients undergoing chemotherapy and bone marrow transplantation to determine whether an LHRH (luteinizing hormone-releasing hormone) agonist can enhance the recovery of T cells. Analysis of key data showed a significant increase in na ve CD4+ T cells and CD4+ TRECs, confirming previously reported interim results.

• Phosphagenics Ltd., of Melbourne, Australia, received Ethics Committee approval for a Phase I trial of its transdermal insulin delivery product, TPM-02/Insulin, which is being developed as a novel way of administering insulin to diabetics. The trial, planned to start this month, follows the successful preclinical trials reported in May.

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