• Avalon Pharmaceuticals Inc., of Germantown, Md., initiated a Phase II pancreatic cancer trial with lead product AVN944, a small-molecule inhibitor of inosine monosphospate dehydrogenase. The open-label trial will include a dose-escalation portion and a safety and efficacy portion, which together will enroll 125 to 140 patients. AVN944 will be administered in combination with gemcitabine. Last month, Avalon released positive interim data from a Phase I trial of AVN944 in hematologic malignancies.

• Barrier Therapeutics Inc., of Princeton, N.J., disclosed positive results from its Phase II dose-finding study of oral rambazole, a retinoic acid metabolism-blocking agent, in moderate to severe psoriasis. The company has selected the 2-mg dose for further development based on a statistically significant positive dose response trend for the PASI 75 assessment, a measure designed to show an improvement of at least 75 percent in psoriasis. In addition, the drug was well tolerated at all doses studied.

• CardioMetabolics Inc., of Edmonton, Alberta, said it plans this month to start the Phase II Mini-METRxICS trial of its CMI X-11S technology. The goal of the 80-patient study is to reduce intensive care unit stays in geriatric patients undergoing cardiopulmonary bypass surgery. The trial in Canada is not powered to demonstrate significance, but to confirm trends seen earlier in younger patients. The company said it already has approvals in place authorizing Phase III trials in the U.S. and Canada.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., said the investigational new drug application has been accepted by the FDA, and it is starting a proof-of-concept trial to assess the safety and pharmacokinetics of various formulations of COL-003 compared to a currently marketed product used as a control. The study is designed as an open-label, controlled, crossover comparison study in healthy subjects. COL-003 uses Collegium's DETERx technology and is a sustained-release oral dosage form designed to be more resistant to tampering and abuse than traditional formulations of the drug.

• DOR BioPharma Inc., of Miami, started patient enrollment in a Phase II trial with orBec for the prevention of acute graft-vs.-host disease after allogeneic hematopoietic cell transplantation with myeloablative conditioning regimens. The trial will seek to enroll up to 138 (92 orBec and 46 placebo) patients. The primary endpoint is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment by day 90 after transplantation. Enrollment is expected to be completed in the second quarter of 2008. OrBec, short for oral beclomethasone dipropionate, is DOR's locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD. A new drug application is on file with the FDA.

• Dynavax Technologies Corp., of Berkeley, Calif., completed enrollment of its Phase III pivotal trial of Heplisav, a hepatitis B vaccine. The U.S. safety and immunogenicity study - a second key clinical trial designed to support the licensure - is expected to complete enrollment before the end of this month. The multicenter study in Canada and in Germany enrolled more than 2,000 subjects, as planned. The data from both trials, plus lot-to-lot consistency trials scheduled to begin in the second half of 2007, will contribute to a safety database of about 4,000 subjects for a planned biologics license application submission in 2008.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said two Phase III trials of its ketoprofen patch for treating soft-tissue injuries failed to demonstrate efficacy. One of the double-blind, placebo-controlled trials evaluated the ketoprofen patch as a treatment for ankle sprains and strains; the second was targeted at treating the pain associated with tendonitis or bursitis of the shoulder, elbow or knee. No statistically significant difference vs. placebo was observed in either trial in the primary endpoint of average pain intensity during daily activities. A third Phase III study, evaluating the ketoprofen patch in pain associated with tendonitis or bursitis of the shoulder, elbow or knee, is ongoing. Also ongoing is an open-label, three-month Phase III study evaluating the product in patients with osteoarthritis flare in the knee. Endo's stock (NASDAQ:ENDP) fell 48 cents Thursday to close at $34.22.

• GTx Inc., of Memphis, Tenn., said a per-protocol interim safety review by a data safety monitoring board recommended that GTx continue clinical development as planned with its two pivotal Phase III clinical trials of Acapodene (toremifene citrate), a selective estrogen receptor modulator. GTx is developing the drug for the treatment of multiple side effects of androgen deprivation therapy for prostate cancer and for prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia.

• LAB International Inc., of Montreal, reported four-week interim results from a Phase II trial of its growth hormone-releasing hormone analogue in chronic kidney disease. The drug induced a fivefold increase in endogenous growth hormone secretion (p=0.0024) and a near doubling of circulating insulin-like growth factor (p=0.0001) compared to placebo at the end of four weeks, as well as a trend toward increased protein synthesis. Additional data are expected in the third quarter.

• LifeCycle Pharma, of Horsholm, Denmark, said it will initiate a Phase II trial of LCP-AtorFen, a fixed-dose combination of atorvastatin and fenofibrate, for the treatment of high cholesterol levels. The 200-patient, double-blind, randomized, active-controlled trial will compare LCP-AtorFen with Lipitor (atorvastatin, Pfizer Inc.) and Tricor (fenofibrate, Abbott). Data are expected next year.

• MethylGene Inc., of Montreal, with partner Pharmion Corp., of Boulder, Colo., started a single-agent Phase II trial of the isotype-specific histone deacetylase inhibitor product candidate MGCD0103 in patients with refractory chronic lymphocytic leukemia. Candidates for the study are adult patients who have refractory CLL or who are not candidates for current standard treatment options. The open-label trial (Trial 009) will enroll up to 40 patients and be conducted at cancer centers in North America.

• Pain Therapeutics Inc., of South San Francisco, and King Pharmaceuticals Inc., of Bristol, Tenn., completed enrollment of a targeted 400 patients in a randomized, double-blind, placebo-controlled Phase III trial of Remoxy in moderate to severe osteoarthritic pain. Top-line data are expected in the fourth quarter and, if positive, would serve as the basis for a regulatory filing. The abuse-resistant, long-acting version of oxycodone uses technology licensed from Durect Corp., of Cupertino, Calif.

• Protherics plc, of London, said the maximum tolerated dose for one of its earlier-stage pipeline products, the targeted chemotherapy drug Prolarix, has been reached in a Phase I cancer trial. Data from the trial will be reported in the first half of 2008, and Protherics plans to begin a Phase II trial in primary liver cancer in the first half of 2008. Prolarix is a combination of tretazicar, a small-molecule prodrug activated by an endogenous enzyme called NQO2, and caricotamide, a co-substrate of NQO2 also involved in activation.

• Rigel Pharmaceuticals Inc., of South San Francisco, said partner Merck Serono, a division of Merck KGaA, of Darmstadt, Germany, has began enrolling patients in a Phase I study to evaluate R763/AS703569 in combination with a standard-of-care therapy in patients with advanced malignancies. This is the third Phase I study planned to evaluate the safety and initial activity of R763/AS703569, described as a highly potent, orally available Aurora kinase inhibitor.

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., received fast-track designation from the FDA for its ghrelin agonist, TZP-101, for the treatment of severe gastroparesis. Tranzyme is developing TZP-101 as a first-in-class prokinetic agent for the treatment of severe gastroparesis and postoperative ileus.