• Advanced Viral Research Corp., of Yonkers, N.Y., said preliminary findings from its ongoing Phase II dermatological study show topical treatment with AVR118 appears to have clinical activity in reducing inflammation and redness associated with surgical incisions or dermatologic dermabrasion. The open label study is evaluating the activity of a topically applied spray formulation of AVR 118 as an anti-inflammatory and regenerative healing agent.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., presented results from two Phase I trials of an intramuscular formulation of peramivir at the Options for the Control of Influenza Conference in Toronto. Positive data on bioavailability and tolerability data were seen. The neuraminidase inhibitor peramivir was the subject early this year of a four-year, $102.6 million contract award from the U.S. Department of Health and Human Services. Those funds will support Phase II and Phase III development activities. (See BioWorld Today, Jan. 5, 2007.)

• Genzyme Corp., of Cambridge, Mass., announced the results of two new studies comparing a powder form of Renvela (sevelamer carbonate) to Renagel tablets (sevelamer hydrochloride), including one trial in which patients received the powder form three times per day, and one in which it was administered once per day. In the three-times-per-day trial, patients experienced equivalent phosphorus control to patients treated with Renagel tablets three times per day. As a result, the trial successfully met its primary endpoint. In the second trial, patients dosed with the powder form of Renvela once per day and those treated with Renagel tablets three times per day achieved statistically significant reductions in serum phosphorus, with both groups reaching target levels for phosphorus control outlined in the K/DOQI treatment guidelines. Phosphorus levels in the Renagel arm (4.6 mg/dL) were lower than those in the Renvela arm (5.3 mg/dL), and this trial did not achieve its primary endpoint of demonstrating non-inferiority of Renvela powder dosed once per day to Renagel tablets dosed three times per day. Genzyme said it will continue to move ahead "aggressively" with clinical and regulatory plans for the three times per day dosage, and these data will form part of an new drug application submission in the first half of 2008.

• Keryx Biopharmaceuticals, of New York, has randomized the last patient in its pivotal Phase III trial of Sulonex (sulodexide oral gelcap), its lead drug candidate, for the treatment of diabetic nephropathy. This trial, with 1,057 patients worldwide, is being conducted under the Subpart-H guidelines for accelerated approval pursuant to a special protocol assessment with the FDA. The company expects to have the last patient complete the six months of active treatment before the end of the year. The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients with type 2 diabetes and persistent microalbuminuria, or diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). A concurrent Phase IV trial is being enrolled comparing 200 mg daily of Sulonex versus placebo.

• NicOx SA, of Sophia Antipolis, France, and the U.S. National Cancer Institute have decided to put an end to a Phase I clinical trial of NCX 4016, in which the drug was being tested as a potential preventive treatment for colon cancer. The decision was taken as a precautionary measure following the results of preclinical tests in vitro of the genotoxicity of NCX 415, a potential specific metabolite of NCX 4016. The company pointed out that these results did not correspond with earlier genotoxicity tests of NCX 4016, or with an in vivo test of NCX 4015 that showed an absence of genotoxicity. But it has decided to defer two planned Phase II trials of NCX 4016 in the indication of type 2 diabetes, pending the completion of additional tests of NCX 4015. In May NicOx halted the development of another drug candidate, NCX 1000, which was undergoing a Phase IIa clinical trial for the treatment of portal hypertension and was being co-developed with Axcan Pharma, of Mont-Saint-Hilaire, Quebec.

• Novelos Therapeutics Inc., of Newton, Mass., reported encouraging results in an ongoing Phase II trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. To date, 10 patients were evaluable for best overall tumor response (assessed at least after eight weeks/two chemotherapy cycles), and all 10 women had previously failed three lines of chemotherapy and were starting the fourth line. One patient had a partial response, five had stable disease and four had progressive disease. NOV-002 was well-tolerated. Up to 25 women may be enrolled in the trial and may receive up to six cycles of NOV-002 and carboplatin.

• Salix Pharmaceuticals Ltd., of Raleigh, NC, has successfully completed its Phase III registration trial to evaluate the safety and efficacy of a new 1100 mg tablet formulation of balsalazide disodium (balsalazide tablets). Balsalazide disodium is the active ingredient in Colazal capsules 750 mg, an anti-inflammatory drug approved and marketed for mild to moderately active ulcerative colitis. When compared to placebo, a statistically significant greater proportion of subjects dosed twice daily with balsalazide tablets for eight weeks achieved clinical improvement. The company said this was true for both the primary efficacy endpoint (clinical improvement in Disease Activity Index of greater than or equal to 3 points with improvement in rectal bleeding) as well as the following key secondary efficacy endpoints: clinical remission, mucosal healing, improvement of rectal bleeding and improvement in physician global assessment. The findings, along with the positive findings of Phase I trials assessing formulation performance under specific conditions, will be the basis for a new drug application which the company expects to file by July 31.

• StemCells Inc., of Palo Alto, Calif., said the Phase I clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells) has completed enrollment of the low-dose cohort and will proceed to the high-dose cohort. The trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC as a treatment for infantile and late infantile neuronal ceroid lipofuscinosis, also referred to as Batten disease.

• Vical Inc., of San Diego, said licensee AnGes MG Inc., of Osaka, Japan, reported Phase III data strong enough for its angiogenesis product candidate that an independent monitoring committee recommended stopping the trial early due to ethical concerns about the placebo group. Interim analysis from the first 41 subjects to complete the trial showed that the primary endpoint had been achieved with statistical significance, and there were no major safety concerns. AnGes is ending the trial for the product, AMG 0001, and preparing to file an application for Japanese marketing approval. The results position the AnGes product candidate to be the first approved for human use based on Vical DNA delivery technology, and provide proof of concept for DNA delivery in the treatment of disease, Vical said. The treatment uses Vical technology to deliver a gene encoding Hepatocyte Growth Factor, a human protein that causes angiogenesis (growth of blood vessels) in areas of restricted blood flow. In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain (VAS [Visual Analog Scale]) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in the placebo group and 70.4% improvement in the treatment group, a statistically significant difference (p=0.014). News of the development sent Vical's stock (NASDAQ:VICL) up 19.2 percent to close at $5.95.

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