• Achillion Pharmaceuticals Inc., of New Haven, Conn., announced preliminary 12-week results from an ongoing Phase II trial studying elvucitabine in patients infected with wild-type HIV. The results at 12 weeks demonstrated potent antiviral activity similar to 3TC, with a mean change in HIV-RNA from baseline in the elvucitabine group of -2.7 log10 (+/-0.82) vs. -3.0 log10 (+/-0.79) in the 3TC group. In addition, elvucitabine was well tolerated, with no serious drug-related adverse events. Full results from that trial, along with data extending to 24-weeks, will be presented at a future scientific forum.

• Anesiva Inc., of South San Francisco, said top-line Phase III data indicated Zingo (lidocaine hydrochloride monohydrate via powder intradermal injection) reduced the pain associated with venous procedures in adult patients. The drug was approved by the FDA in August for use in children ages 3 to 18, and Anesiva plans to file a supplemental new drug application in the first quarter of 2008 for use in adults. (See BioWorld Today, Aug. 20, 2007.)

• Biovest International Inc., of Worcester, Mass., said it plans to seek accelerated conditional approval for BiovaxID, its anticancer vaccine for its treatment of non-Hodgkin's lymphoma, in the U.S., Europe and Switzerland. A Phase III trial was begun by the National Cancer Institute in 2000, and the company performed a data lock, at the suggestion of its data monitoring committee, in September and anticipates having an interim data analysis of unblinded data on the primary endpoint of disease-free survival for BiovaxID completed and publicly disclosed by March. The DMC confirmed that there were no safety concerns. Shares of Biovest (OTC BB:BVTI) gained 9 cents or 21 percent Tuesday to close at 49 cents.

• Curis Inc., of Cambridge, Mass., said partner Genentech Inc., of South San Francisco, has initiated an expansion cohort in its ongoing Phase I clinical trial of a systemically administered Hedgehog antagonist. As a result, Curis will receive a $3 million cash payment from Genentech under the parties' June 2003 collaboration agreement. Genentech began a Phase I clinical trial in January, which is designed as an open-label study of a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that are refractory to standard therapy or for whom no standard therapies exist. The initial objectives of the Phase I clinical trial have been achieved, and the expansion cohort is expected to enroll additional patients.

• Evotec AG, of Hamburg, Germany, announced positive top-line results from its second Phase II trial of EVT 201 in elderly primary insomnia patients with daytime sleepiness. Those top-line results are from the prespecified intention-to-treat analysis from the 149 patients who were randomized into the study. The study showed a highly significant improvement between both doses of EVT 201 and placebo on the primary endpoint of polysomnography (PSG) derived Total Sleep Time (TST); compared to placebo, mean TST increased by 30.9 minutes (9%) on EVT 2,01 1.5 mg and 56.4 minutes (17%) on EVT 201 2.5 mg; p=0.0001 and p=<0.0001 respectively. Significant improvements were also seen across key PSG-derived secondary endpoints including Wake After Sleep Onset and Latency to Persistent Sleep.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, initiated a Phase I/II trial of insulin sensitizer Triolex (HE3286) in obese, insulin-resistant volunteers. The 28-day trial will evaluate safety and determine the optimal dose for a 28-day Phase I/IIb study, which is slated for the first half of 2008. Triolex modulates the NF-kappaB pathway and has lowered glucose and increased insulin sensitivity in preclinical studies.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas., presented data regarding Phase I clinical trial results for LX1031. The studies demonstrated LX1031 was generally well tolerated at all dose levels and that exposure levels in blood were low. A statistically significant reduction of urinary 5-hydroxyindoleacetic acid (5-HIAA), a metabolite of serotonin and biomarker for serotonin production, was observed in subjects who received the highest dose tested, 2,000 mg per day, for two weeks. Over the 14-day trial, no dose-limiting toxicities were observed. The data were presented at the American College of Gastroenterology in Philadelphia.

• Repros Therapeutics Inc., of The Woodlands, Texas, reported the outcome of an FDA meeting regarding Androxal for secondary hypogonadism. The agency and the company mutually agreed that endpoints associated with male sexuality would not be appropriate for future trials, so Repros plans to submit a revised protocol focusing on endocrinological outcomes. In a recent Phase III trial, Androxal was shown to be not inferior to Androgel (testosterone gel, Solvay SA) based on testosterone levels, but Androxal also had unique effects on luteinizing hormone, follicle stimulating hormone and blood glucose that the company said may indicate additional applicability in adult-onset idiopathic hypogonadotropic hypogonadism. Shares of Repros (NASDAQ:RPRX) rose $1.96, or 18.3 percent, to close at $12.69 on Tuesday.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., completed the in-life portion of its two pivotal Phase III trials of Puricase (pegloticase) in patients with treatment-failure gout, an orphan indication. The studies included more than 200 patients who were randomized to receive either Puricase or placebo, administered by a two-hour intravenous injection. The company said it remains on track to report top-line results in December. Puricase is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective.

• ViRexx Medical Corp., of Edmonton, Alberta, reported the 118th relapse event the second of its two pivotal Phase III studies, the IMPACT II trial of its monoclonal antibody, OvaRex MAb, in women with Stage III or Stage IV ovarian cancer who had successfully completed front-line therapy. The first study, IMPACT I recorded its 118th relapse event in December 2006, and now that both trials have reached that milestone, the clinical records can be compiled and reviewed prior to starting data analysis. Both trials are designed to enroll 177 patients and to measure the drug's efficacy using time-to-relapse as the primary endpoint.