• Barrier Therapeutics Inc., of Princeton, N.J., said a Phase II/IIII trial of liarozole in lamellar ichthyosis showed it effectively treated the disorder in 41 percent and 50 percent of patients taking one of two doses. The randomized, double-blind, placebo-controlled study enrolled 64 patients in three treatment groups. Patients received placebo or drug daily for 12 weeks. Response rates for the primary endpoint were 41 percent (11 of 27 patients) for the 75-mg dose, 50 percent (14 of 28 patients) for the 150-mg dose and 11 percent (one of nine patients) for placebo. The "p" values for the 75-mg and 150-mg groups compared to placebo were p=0.2193 and p=0.0557, respectively. Lamellar ichthyosis is a rare genetic disorder characterized by a thick scaling of the skin over large body areas. Barrier's stock (NASDAQ:BTRX) fell 24 cents Thursday, or 3.7 percent, to close at $6.32.

• Cavit Sciences Inc., of Delray Beach, Fla., said its lead product candidate, CT-5, demonstrated promising results in in vitro, animal and human testing. It said human studies demonstrated improvements in progression-free survival in combination with other agents in cancer patients. In vitro test showed inhibition of HIV-1 replication, it said, while animal tests showed good data in cancers. CT-5 is a diluted form of Maruyama vaccine, which has been used for more than 25 years as a cancer treatment in Japan, Cavit said.

• CombinatoRx Inc., of Cambridge, Mass., presented additional data related to its immuno-inflammatory product candidates CRx-102 and CRx-139, at the annual congress of the European League Against Rheumatism in Barcelona, Spain. The company said data on CRx-102 provided additional evidence of its clinical benefit and novel mechanism of action, which will be useful in the design of future studies and in understanding the product's potential role in treating rheumatoid arthritis and osteoarthritis. Additional data from a Phase IIa trial of CRx-139 showed subjects treated with a high dose of CRx-139 (3 mg of prednisolone and 20 mg of paroxetine) had improved ACR 50 responses compared to low-dose CRx-139 with prednisolone or 3 mg of prednisolone alone.

• Depomed Inc., of Menlo Park, Calif., began dosing patients in a Phase II trial of Gabapentin GR, an extended-release formulation of the approved drug, for the treatment of menopausal hot flashes. The 13-week, double-blind, placebo-controlled trial in 108 menopausal women experiencing recurrent moderate to severe hot flashes will be conducted at about 10 sites in the U.S. and Canada. The primary endpoint is the frequency and severity of hot flashes, relative to baseline. Secondary endpoints include efficacy relative to placebo, average daily frequency and severity score of hot flashes and sleep quality. Depomed's stock (NASDAQ:DEPO) gained 54 cents Thursday, or 12 percent, to close at $5.

• Genzyme Corp., of Cambridge, Mass., had results of a long-term extension study of its Fabry disease drug Fabrazyme (agalsidase beta) published in the Journal of the American Society of Nephrology. The 54-month Phase III, open-label extension study demonstrated that early intervention with Fabrazyme preserves renal function and stabilizes renal disease progression in patients with the rare, genetic disease. Fabrazyme is an enzyme replacement therapy for the disease, which is caused by a deficiency of the lysosomal enzyme alpha-galactosidase A.

• Human Genome Sciences Inc., of Rockville, Md., presented Phase II data demonstrating that LymphoStat-B (belimumab) significantly reduced disease activity across multiple clinical measures, was well tolerated and improved quality of life in patients with active systemic lupus erythematosus. The 52-week and 76-week results of the Phase II study were the subject of a presentation at the annual congress of the European League Against Rheumatism in Barcelona, Spain. Significant reductions in SLE disease activity were seen through week 52, and continued improvements were seen from week 52 through week 76 in the extension phase of the trial. The product is being tested in Phase III trials. (See BioWorld Today, Feb. 14, 2007.)

• Living Cell Technologies Ltd., of Melbourne, Australia, said it successfully dosed the first patient in a Phase I/IIa clinical trial in Moscow using its DiabeCell pig pancreatic cell product to treat Type I diabetes. The trial is being conducted in insulin-dependent diabetics. Recipients in the first trial are given the lowest clinically effective dose to demonstrate safety, and then dosing is repeated for additional clinical benefit. The patients receive an initial transplant dose equivalent to 5,000 IEQ (islet equivalents/kg) administered by injection into the peritoneal cavity, followed by a second transplant six months later. Follow-up monitoring will continue for 12 months. The primary efficacy endpoint is reduction in hemoglobin A1C levels over the 12-month post-transplant period compared with baseline. Secondary efficacy endpoints include glucose lability, reductions in hypoglycemia and nocturnal hypoglycemia, reductions in the average daily insulin dose, changes in endogenous insulin secretion and quality-of-life changes.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., will have its approved drug Velcade tested in a Phase I trial. The Multiple Myeloma Research Consortium and Emory University began a Phase I trial to determine the optimal dose level of Velcade (bortezomib) for injection, a proteasome inhibitor, in combination with tipifarnib, a first-in-clinic farnesyl transferase inhibitor, for the treatment of patients with relapsed or refractory multiple myeloma. Preclinical data suggested the drugs in combination have synergistic activity against multiple myeloma cells.

• Neurogen Corp., of Branford, Conn., said data from previously reported Phase I and IIa studies for NG2-73 were presented at the Associated Professional Sleep Societies meeting in Minneapolis. NG2-73 is a partial agonist with preference for GABA(A) receptors containing the alpha-3 subunit. Two Phase IIb trials of the product in chronic insomnia patients are ongoing.

• Pharmasset Inc., of Princeton, N.J., said data on Clevudine and Racivir were presented at the International HIV Drug Resistance Workshop in St. Michael, Barbados. An in vitro study of Clevudine, expected to enter Phase III trials for treating hepatitis B virus, demonstrated it does not inhibit HIV, making it potentially useful for treating co-infected patients. Also, a clonal analysis of the Phase II viral samples for Racivir, being developed for HIV, confirmed its antiviral activity in treatment-experienced patients with the M184V mutation and less than three thymidine analogue mutations.

• Vanda Pharmaceuticals Inc., of Rockville, Md., said data were presented on VEC-162, a balanced melatonin receptor agonist, demonstrating improvements in objective and subjective measures of sleep onset and maintenance in a Phase III trial of transient insomnia. The previously reported data demonstrated statistically significant improvements at all three tested doses compared to placebo (p<0.001) in the primary endpoint of the trial, latency to persistent sleep. Data were presented at the Associated Professional Sleep Societies meeting in Minneapolis.

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