• Achillion Pharmaceuticals Inc., of New Haven, Conn., said it presented data validating the clinical antiviral activity of one of its NS4A antagonists, ACH-806, for treating hepatitis C virus infection. In the first presentation of human antiviral activity, a monotherapy study showed a mean change in HCV RNA (log10) at day five was a decrease of 0.91 from baseline for treated subjects vs. an increase of 0.05 for placebo subjects. Achillion also presented data on the synergy with other classes of HCV inhibitors, and the unique mode of action of antagonism of NS4A, a viral protein that binds to a portion of HCV protease. Achillion and partner Gilead Sciences Inc., of Foster City, Calif., previously discontinued development of ACH-806 based on increases in serum creatinine levels, an effect Achillion said did not appear to be target-related. Data were presented at the annual meeting of the European Association for the Study of the Liver in Barcelona Spain.

• Antigenics Inc., of New York, said updated data from a Phase I/II investigator-sponsored trial of cancer vaccine Oncophage (vitespen) indicated the drug was associated with significant tumor-specific immune responses (p<.001) in all 12 high-grade glioma patients treated. Seven of eight patients who have completed treatment exceeded the historical median benchmark of 6.5 months survival from time of recurrence. The Phase II portion of the study is expected to move forward in mid-2007. A Phase III trial of Oncophage in kidney cancer failed to meet its primary endpoint last year, but a nonregistration trial in melanoma showed a survival benefit in certain patients. The new data were presented at the 75th annual meeting of the American Association of Neurological Surgeons and bumped shares of Antigenics (NASDAQ:AGEN) up 20.7 percent, or 76 cents, to $4.43 on Monday. (See BioWorld Today, Oct. 12, 2005, and March 27, 2006.)

• Ceregene Inc., of San Diego, presented 12-month follow-up data from an open-label Phase I trial of gene therapy product CERE-120 in Parkinson's disease. The treatment was well tolerated, and patients demonstrated a 36 percent (p<0.001) reduction in Parkinson's symptoms at 12 months after administration. The Phase I trial was partially funded by The Michael J. Fox Foundation for Parkinson's Research, which has also provided $1.9 million to support an ongoing Phase II trial. The data were presented at the 75th annual meeting of the American Association of Neurological Surgeons.

• Expression Genetics Inc., of Huntsville, Ala., completed a Phase I study of EGEN-001, the company's lead candidate, showing that the treatment was well tolerated with no apparent dose-related trends when administered intraperitoneally by four weekly infusions in chemotherapy-resistant patients with advanced stage, recurrent ovarian cancer. Secondary endpoints involved clinical and biological parameters, and those data included an overall median survival of more than 12.2 months with seven out of 13 patients still surviving to date. EGEN-001, which uses the company's TeraPlas delivery technology, is composed of interleukin-12 gene expression plasmid formulated with a biocompatible delivery polymer and aims to increase local concentration of IL-12 protein. The company has been granted orphan status by the FDA. Expression Genetics expects immediately to start enrolling patients in its next study, which will combine EGEN-001 administration with conventional chemotherapy in platinum-sensitive recurrent ovarian cancer patients.

• Genzyme Corp., of Cambridge, Mass., said a recently completed study of Renvela (sevelamer carbonate) achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for hyperphosphatemic patients with chronic kidney disease who are not on dialysis. Renvela-treated patients also achieved a significant reduction in calcium-phosphorus product and in LDL cholesterol. The drug was well tolerated, with a safety profile consistent with the clinical experience of patients on dialysis using its Renagel (sevelamer hydrochloride) product. The single-arm, open-label trial involved 49 patients at sites in Europe and Australia. A new drug application for Renvela is under review by the FDA for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (See BioWorld Today, Dec. 22, 2006.)

• Human Genome Sciences Inc., of Rockville, Md., reported 12-week data from a Phase IIb trial of Albuferon (albinterferon alfa-2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naive to interferon alpha-based treatment regimens. Interim data demonstrated Albuferon provided at least comparable efficacy to Pegasys, with a 59 percent rate of sustained virologic response at 12 weeks vs. 54 percent for Pegasys (peginterferon alfa-2a). The Albuferon group also had more favorable health-related quality-of-life scores than the Pegasys group. Separately, interim data showed Albuferon with ribavirin in 43 treatment-naive patients with genotype 2 or 3 chronic hepatitis C was well tolerated and exhibited robust antiviral activity. HGS and Novartis AG, of Basel, Switzerland, are planning an additional study to identify the optimal dose for Albuferon dosed monthly. Albuferon is a long-acting form of interferon alpha created using HGS' albumin fusion technology. Data were presented at the annual meeting of the European Association for the Study of the Liver in Barcelona, Spain.

• Kalypsys Inc., of San Diego, initiated a second Phase I trial of KD7040, a topical inducible nitric oxide synthase (iNOS) inhibitor for neuropathic pain. The company completed a single-dose escalation study in March and expects to finish the multiple dose trial in mid-2007. Together, the trials are evaluating the drug against placebo in healthy volunteers for safety, tolerability and pharmacokinetics. The initial clinical focus is to investigate the compound's therapeutic effect in postherpetic neuralgia.

• Nereus Pharmaceuticals Inc., of San Diego, said the first patient was enrolled in a multicenter Phase I trial of its second-generation proteasome inhibitor, NPI-0052, in patients with multiple myeloma. The study, with the Multiple Myeloma Research Consortium, will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of NPI-0052 in a single-agent, dose-escalation study in patients with relapsed or refractory multiple myeloma. NPI-0052 was discovered from a new marine actinomycete (Salinispora tropica). Preclinical studies indicated NPI-0052 is active against models of many common cancers.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said Stage 1 results from its Phase II trial of PI-88 in patients who previously had undergone surgical removal of liver cancer demonstrated an improvement in disease-free rate, the primary endpoint, of 25 percent and a prolongation in the time to tumor recurrence from 27 to 48 weeks. The 48-week data built on previously released 30-week results announced in December. Progen said rather than conducting Stage 2 of the Phase II trial, it now is planning a multinational Phase III trial of PI-88 at a dose of 160 mg/day. Enrollment is expected to begin in the second half of 2007. The Phase III trial of the anti-angiogenesis agent will be designed with overall survival and disease-free survival endpoints.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., presented data from a planned interim analysis of the PROVE 1 trial, the first trial to evaluate short-duration therapy with the investigational hepatitis C protease inhibitor telaprevir (VX-950) in combination with pegylated interferon and ribavirin in treatment-naive, genotype 1 hepatitis C patients. PROVE 1 demonstrated a high rate of rapid viral response in the telaprevir groups and a low rate of on-treatment viral breakthrough, and suggested that 12 weeks of telaprevir-based therapy enabled some patients to clear the virus. The treatment discontinuation rate due to adverse events through 12 weeks was 11 percent in telaprevir arms and 3 percent in the control arm, however. Telaprevir, oral inhibitor of HCV protease, is being developed with Tibotec Pharmaceuticals Ltd., a Cork, Ireland, unit of Johnson & Johnson. Data were presented at the annual meeting of the European Association for the Study of the Liver in Barcelona, Spain.