• AspenBio Pharma Inc., of Castle Rock, Colo., said results from ongoing research and clinical studies show that its human appendicitis blood test appears able to identify patients with appendicitis at a very high sensitivity level of 94 percent to 97 percent, compared to significantly lower diagnostic success rates for CT scans. Three studies have been conducted during the past 30 months, with one 400-patient study still ongoing. AspenBio anticipates a regulatory filing with the FDA later this year.

• Callisto Pharmaceuticals Inc., of New York, initiated a Phase I trial of L-Annamycin in pediatric refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML). The multicenter, open-label, dose-escalation trial will evaluate safety, establish the maximum tolerated dose and look for efficacy. Last fall, Callisto raised $5.75 million through the sale of stock and warrants to fund this trial as well as an ongoing Phase I with L-Annamycin in adult ALL and Phase II trials with cancer drug Atiprimod. (See BioWorld Today, Dec. 28, 2006.)

• Cell Genesys Inc., of South San Francisco, and Medarex Inc., of Princeton, N.J., presented follow-up data from a Phase I trial of Cell Genesys' GVAX immunotherapy for prostate cancer administered in combination with Medarex's anti-CTLA-4 antibody, ipilimumab (MDX-010). The trial will enroll 25 to 30 patients, but five of six treated so far in the two highest dose groups exhibited antitumor activity including significant declines in prostate-specific antigen (PSA). Clinical evidence of antitumor activity was observed in three of the five PSA responders, including improvement of lesions, resolution of abdominal lymph node disease and decreased pain due to bone metastases. The data were presented at the American Society of Clinical Oncology (ASCO) Prostate Cancer Symposium in Orlando, Fla.

• Kuros Biosurgery AG, of Zurich, Switzerland, said the FDA granted orphan drug designation to the novel bioactive substance of Kuros' bone-repair product, I-040302, for the treatment of solitary bone cysts. The product, licensed to Deerfield, Ill.-based Baxter International Inc. in 2005, consists of a fusion protein derivative of human parathyroid hormone combined with Baxter's fibrin sealant. Clinical studies are expected to be initiated this year.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said an undisclosed licensee began European clinical trials of an anticancer agent developed with tumor necrosis therapy technology licensed from Peregrine. The technology targets DNA that is released by dead and dying cells found at the center of tumors. Peregrine would get royalties on resulting sales.

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