• Agendia BV, of Amsterdam, the Netherlands, presented data showing its ColoPrint product can predict the risk of relapse and recurrence in Stage II colon cancer patients. The technology is based on microarray gene expression profiles.

• Aldagen Inc., of Durham, N.C., added three new sites for its 20-patient trial with ALD-301 for the treatment of critical limb ischemia: Duke University Medical Center, also in Durham; Indiana University, in Indianapolis; and St. Joseph's Research Institute, in Atlanta. The sites join Texas Heart Institute at St. Luke's Episcopal Hospital in Houston. ALD-301 is described as a potent population of stem and progenitor cells isolated from patient's bone marrow, and is given via intramuscular injections into the lower half of the leg.

• AVI BioPharma Inc., of Portland, Ore., said partner Cook Medical, of Bloomington, Ind., completed patient enrollment and released six-month follow-up data from the Phase II APPRAISAL trial in Germany. The trial is designed to study the effect of the Neugene antisense drug Resten-MP when used in conjunction with the placement of one or more bare metal stents, in the prevention of cardiovascular restenosis.

• CardioVascular BioTherapeutics Inc., of Las Vegas, said the FDA authorized the company's Phase II clinical protocol for its protein drug candidate, human fibroblast growth factor-1, for the treatment of severe coronary heart disease. The protocol incorporates injection catheter delivery of FGF-1. It is expected to be run at 30 medical centers in the U.S., Canada and Europe. The use of a catheter to deliver CVBT's drug candidate permits the examination of a placebo-control group in the trial, which was not possible when the drug was surgically administered in the Phase I study.

• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., initiated a randomized, double-blind, placebo-controlled Phase II trial of CPP-109 in patients with cocaine dependence. CPP-109 (vigabatrin) is an orally administered, small-molecule compound designed to inhibit psychostimulant-induced dopamine release. The Phase II trial will evaluate safety and efficacy in 180 cocaine-dependent patients at 10 addiction treatment centers in the U.S. The primary endpoint is patients being cocaine-free during their last two weeks of treatment.

• Cell Genesys Inc., of South San Francisco, completed enrollment in its VITAL-1 Phase III trial of prostate cancer immunotherapeutic GVAX, allowing the company to predict the timing of a preplanned interim analysis and a final analysis, estimated to occur in the first half of 2008 and in 2009, respectively. The 600-patient, multi-center, randomized, controlled study compares GVAX to Taxotere (docetaxel) plus prednisone, with a primary endpoint of improving survival. A second GVAX Phase III prostate cancer trial known as VITAL-2 is planned and the company will update its enrollment status by the end of 2007.

• Critical Therapeutics Inc., of Lexington, Mass., enrolled the first patient in its Phase IV trial of Zyflo CR (zileuton extended-release) in asthma that is poorly controlled by moderate doses of inhaled corticosteroids. The 400-patient, randomized, double-blind, placebo-controlled trial is design to support marketing of Zyflo CR, which will begin in the U.S. this fall. Zyflo IR and Zyflo CR are leukotriene synthesis inhibitors approved for prophylaxis and chronic treatment of asthma.

• Epeius Biotechnologies Corp., of San Marino, Calif., said it will initiate a Phase I/II refractory prostate cancer trial this summer using its Rexin-G tumor-targeted gene delivery system. The trial will use an adaptive design that allows the assessment of safety data and then the continuation of treatment for efficacy analysis, with dosing determined by tumor response. Phase I/II trials are under way in sarcoma and breast cancer.

• Halozyme Therapeutics Inc., of San Diego, said final results from its 15-patient Enhanze Technology trial demonstrated improved absorption and bioavailability of a representative commercially available large protein molecule therapeutic or LPMT. Enhanze is an enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase or rHuPH20. Injection of rHuPH20 with Humira (adalimumab), the anti-tumor necrosis factor drug from Abbott, of Abbott Park, Ill., was well tolerated at all rHuPH20 dose levels, without dose-limiting toxicity, premature withdrawals or serious adverse events. The company noted that rHuPH20 is the first and only hyaluronidase from a recombinant human source. The results were presented at the annual meeting of the Controlled Release Society in Long Beach, Calif.

• ImmuPharma plc, of London, submitted an investigational new drug application with the FDA for the initiation of a pivotal Phase II/III trial of IPP-201101 in patients with systemic lupus erythematosus. The proposed double-blind, randomized, placebo-controlled, multicenter study would include 240 patients treated during 12 months. It would take place in the U.S., Europe and Latin America and is expected to be completed in early 2009.

• Karo Bio AB, of Stockholm, Sweden, said partner Merck & Co. Inc., of Whitehouse Station, N.J., decided to discontinue development of a Phase I clinical candidate they had identified, due to a poor product profile. A backup compound has been approved for entry into preclinical development. The collaboration targets estrogen receptors, with the aim to develop new treatments in the field of women's health care.

• Manhattan Pharmaceuticals Inc., of New York, said each of two Phase IIa trials of oral Oleoyl-estrone in obesity failed to demonstrate statistically or clinically meaningful weight loss vs. placebo. The randomized, double-blind studies were conducted in common obesity and in morbid obesity. Based on the results, Manhattan will discontinue its OE programs in both indications. Going forward, the company intends to continue advancing its four clinical-stage product candidates, and to explore other opportunities in the areas of dermatology/immunology and endocrine/metabolic disorders. Manhattan's stock (AMEX:MHA) fell 37 cents Tuesday, or 49.3 percent, to close at 38 cents.

• ProMetic Life Sciences Inc., of Montreal, disclosed preliminary data from a Phase Ib/II trial with its orally active drug PBI-1402 for the treatment of chemotherapy-induced anemia (CIA). Clinical activity was confirmed in CIA, a condition that is associated with a 40 percent to 50 percent rate of nonresponse to recombinant erythropoietin, the company noted. Two-thirds of patients enrolled in the study increased their hemoglobin levels by an average of 14g/L of blood and one-third of patients maintained their hemoglobin levels. All patients enrolled with low levels of white blood cells (neutrophils) achieved improved levels during treatment, while patients with normal neutrophil levels remained unchanged, and PBI-1402 was well tolerated by all patients with no serious side effects reported.

• Protox Therapeutics Inc., of Vancouver, British Columbia, released top-line data from a 24-patient Phase I trial of proaerolysin-based PRX302 in localized, recurrent prostate cancer refractory to radiation treatment. The data indicated PRX302 was well tolerated, with no significant adverse events seen at the highest doses. Additionally, the drug reduced both prostate-specific antigen levels and the number of positive biopsies. A Phase I trial evaluating PRX302 in benign prostate hyperplasia is ongoing, as are Phase I and Phase II trials with the cancer drug PRX321.

• Theravance Inc., of South San Francisco, said a Phase II trial of TD-1792 in complicated skin and skin structure infections caused by Gram-positive bacteria met its primary endpoint of non-inferiority to vancomycin. The 197-patient randomized, double-blind study in the U.S. compared safety, efficacy and tolerability of once-daily TD-1792 to twice-daily vancomycin, the standard of care for resistant Gram-positive infections, in patients with cSSSIs caused by Gram-positive bacteria, including resistant strains such as MRSA. Clinical cure rates in the clinically evaluable population were 91.7 percent for TD-1792 (77/84) and 90.7 percent for vancomycin patients (78/86). Clinical cure rates in those with confirmed MRSA infections were 94.7 percent for the TD-1792 arm (36/38) and 91.9 percent for vancomycin (34/37).