• Ambrilia Biopharma Inc., of Montreal, said findings of a Phase I/II study indicate that PCK3145, a therapeutic peptide drug, showed evidence of clinical activity in metastatic prostate cancer patients. Data showed that PCK3145 increased prostate specific antigen (PSA) doubling time in 10 of the 28 metastatic hormone-refractory patients, and results also confirmed down-regulation of MMP-9, a matrix metalloproteinase enzyme involved in facilitating tumor metastasis, in most of the patients.

• Ceragenix Pharmaceuticals Inc., of Denver, reported positive results from its post-clearance marketing study comparing EpiCeram's efficacy to that of Cutivate cream, a mid-strength topical steroid, in the treatment of moderate to severe atopic dermatitis. Data from the 113-patient study demonstrated no statistically significant differences between the treatment groups, as measured by the SCORAD index at day 28, or in the percentage of patients assessed to be clear or almost clear by physician assessment. The company said those data confirmed that EpiCeram provides the same efficacy without the side effect risks often associated with long-term use of topical steroids of immunosuppressants.

• Exelixis Inc., of South San Francisco, said the FDA completed its review of trial protocol for XL999 in patients with non-small-cell lung cancer. That Phase I trial is expected to begin enrolling patients this summer who have failed at least one previous therapy. Results could provide the company a chance to move directly into a late-stage trial if the XL999 demonstrates antitumor activity with an acceptable side-effect profile. XL999 is designed to inhibit the receptor tyrosine kinases implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells.

• Introgen Therapeutics Inc., of Austin, Texas, initiated the efficacy analyses of its Advexin Phase III study. That evaluation will incorporate the prospective analyses of patients defined by clinical and molecular prognostic biomarkers, including abnormal p53 protein levels. Introgen previously received FDA permission to accelerate the Phase III analyses, which are expected to conclude later this year. Pending results, the company anticipates filing for regulatory approval. The Phase III study was designed to compare Advexin p53 therapy vs. methotrexate in patients with recurrent head and neck cancer, with endpoints of tumor response and survival.

• Lexicon Genetics Inc., of The Woodlands, Texas, initiated a Phase Ib trial of LX1031, its investigational drug for irritable bowel syndrome. The study will evaluate multiple doses of LX1031 in about 40 healthy volunteers. Data are expected in the third quarter. LX1031, an oral candidate, is designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation, without affecting serotonin levels in the brain or its central nervous system functions.

• Pharmos Corp., of Iselin, N.J., said results from its Phase IIa trial of intravenous cannabinor against postoperative pain in more than 100 male patients undergoing third molar dental extraction showed that the product met its primary endpoint of producing a statistically significant decrease in pain vs. placebo when administered at the lowest dose of 12 mg. The primary endpoint was determined by a time-weighted measurement of total pain relief. That drug effect was not seen in the higher dose groups (24 mg and 48 mg), however, and the company intends to explore that variation in response. Results showed no treatment-limiting or serious adverse events. Pharmos' product is part of its CB2-selective cannabinoid program in development for chronic pain and autoimmune diseases. News of the Phase IIa results pushed up Pharmos' stock (NASDAQ:PARS) 29 cents, or 19.2 percent, Tuesday to close at $1.79.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., completed dosing in the final patient enrolled in its Phase I study of Provecta in Stage III/IV metastatic melanoma. The company reported that the study's endpoints of safety and preliminary efficacy appear to have been met, though a final follow-up will not be completed for several months. An interim analysis from the first 11 patients indicated that the rate of response for a single intratumoral injection with Provecta was at least several times greater than that typically achieved with standard therapy. A further trial of Provecta is set to begin within several months in up to 80 Stage III/IV melanoma patients. Provecta previously received orphan drug designation in the U.S.

• Y's Therapeutics Co. Ltd., of Tokyo, completed patient enrollment in its Phase II trial of YSPSL, a recombinant P-selectin glycoprotein immunoglobulin, for prevention of delayed graft function in kidney transplant patients. The study enrolled 75 patients. Results will be available after analysis of the six-month follow-up data.