• Antigencs Inc., of New York, said follow-up data from its Phase III trial of therapeutic cancer vaccine Oncophage (vitespen) showed that, in a substantial subset of patients at intermediate risk for disease recurrence, the product demonstrated a clinically significant improvement in recurrence-free survival of about 45 percent. Those end-of-study results reflect an additional 17 months of data collection beyond the top-line results reported in March 2006, in which Oncophage missed its primary endpoints for the entire trial population of 728 kidney cancer patients. Updated analysis of subset data also revealed a trend for intermediate-risk patients toward improved overall survival, which was the study's secondary endpoint. Data were presented at the American Urological Association meeting in Anaheim, Calif. Antigenics said it intends to seek a meeting with the FDA to discuss the trial's final results to determine whether there is an opportunity for filing a biologics license applications based on those data. (See BioWorld Today, March 27, 2006.)

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Phase III results and data from human pharmacology studies reported at the Congress of the European Academy of Dermatology and Venereology highlighted the efficacy and safety profile of alitretinoin as a potential once-daily oral treatment for severe refractory chronic hand eczema. Previously reported results from a pivotal Phase III study confirm the product's efficacy, as 48 percent of patients treated with 30mg per day with once-daily alitretinoin for up to six months responded positively. Response rate and time to response were dose-dependent, with a faster response seen with the higher dose. Alitretinoin was generally well tolerated, with an adverse event profile typical of the retinoid drug class. The company said the collective data would form part of regulatory submissions later this year.

• Cel-Sci Corp., of Vienna, Va., said Multikine significantly increased long term overall survival in a Phase II study of head and neck cancer patients. This final Phase II clinical trial was designed to assess thoroughly the positive safety and efficacy observations made in patients treated with Multikine in CEL-SCI's early Phase II studies. Multikine was given prior to standard care to recently diagnosed and not yet treated cancer patients. Adding the compound to the first treatment (standard of care) resulted in a 33 percent improvement in the median overall survival at three and a half years after surgery, compared to the survival results reported in 55 oral squamous cell carcinoma trials published in the scientific literature between 1987 and 2007. The FDA in January gave Cel-Sci the OK to move forward on a Phase III trial of Multikine in first-line treatment of patients with advanced primary head and neck cancer. The drug is a mixture of cytokines designed to stimulate immune responses. The data were presented at the First International Congress of the International Association of Oral Oncology in Amsterdam, the Netherlands.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, began a placebo-controlled Phase III trial of CUV1647 in polymorphic light eruption to further determine whether the implanted product can prevent or reduce the severity of symptoms and also reduce the use of rescue medication. The randomized, double-blinded, European-based study follows Phase II testing in which CUV1647 significantly reduced the need for rescue medication in the form of steroids or anti-inflammatory drugs in these patients for the sun-induced skin disorder known as sun poisoning. Up to 150 patients will be enrolled in the new study, with interim data available in a year and final results expected in 2009.

•Cougar Biotechnology Inc., of Los Angeles, said positive Phase I and Phase II data on the company's prostate cancer drug candidate CB7630 (abiraterone) were presented at the American Urological Association meeting in Anaheim, Calif. CB7630 was administered orally, once daily, to chemotherapy-naive patients with castration refractory prostate cancer, who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies, including anti-androgens, diethylstilboestrol and dexamethasone. To date a total of 38 patients have been treated in the Phase I/II trial. CB7630 was well tolerated at doses as high as 2,000 mg/day with minimal toxicity. Moreover, no dose limiting toxicity has been observed in the trial to date. In the 30 patients who were evaluable, 18 (60 percent) experienced a confirmed decline in prostate specific antigen levels of greater than 50 percent, with 10 of the 30 patients (33 percent) experiencing PSA declines of greater than 90 percent. Six additional patients (20 percent) experienced a decline in PSA that was less than 50 percent. Of the 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses in 11 patients (55 percent), with 7 patients demonstrating ongoing stable disease and 3 patients experiencing regressing bone disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use.

• Dendreon Corp., of Seattle, said findings reported at the American Urological Association meeting in Anaheim, Calif., showed that an analysis of Phase III studies demonstrated a prolonged survival benefit for patients first treated with Provenge (sipuleucel-T) who then went on to receive docetaxel chemotherapy after disease progression. Specifically, patients who received initial treatment with Provenge followed by docetaxel had a median survival of 34.5 months compared to 25.4 months for those in the placebo arm who received docetaxel, a difference of 9.1 months. In addition, an analysis of overall survival demonstrated that patients in the Provenge arm who received subsequent therapy with docetaxel had a 47 percent reduction in their risk of death compared to those in the placebo arm who received subsequent therapy with docetaxel. Provenge is the subject of a recent approvable letter from the FDA, following a positive advisory committee meeting on the immunotherapy product. (See BioWorld Today, April 2, 2007, and May 10, 2007.)

• Genitope Corp., of Fremont, Calif., initiated a Phase II trial of MyVax personalized immunotherapy following primary treatment with rituximab (Rituxan, Genentech Inc. and Biogen Idec Inc.) and chemotherapy in follicular non-Hodgkin's lymphoma. The trial is expected to enroll about 100 patients to receive six to eight cycles of Rituxan and chemotherapy and, after a six-month rest period, will receive a series of 24 immunizations with MyVax over a 92-week period. MyVax, which is based on the genetic makeup of each patient's own tumor, is designed to activate the patient's immune system to fight the cancer. The product is in pivotal testing in NHL patients following chemotherapy treatment.

• Gilead Sciences Inc., of San Francisco, reported long-term data of ambrisentan, an endothelin receptor antagonist, in patients with pulmonary arterial hypertension, showing that improvements in the non-placebo-corrected six-minute walk distance observed during the first 12 weeks of treatment were sustained for at least 48 weeks and the one-year probability of survival was 95 percent for patients receiving ambrisentan. Those data came from an integrated analysis of an ongoing extension study (ARIES-E) involving 383 patients from the two 12-week Phase III studies. Long-term results from a second study, AMB-222, in patients who previously discontinued the ERAs besentan, sitaxsentan or both due to the development of liver function abnormalities indicated that no patients had liver function abnormalities that required discontinuation of ambrisentan during the 12-week primary endpoint period. Those data were presented at the American Thoracic Society International Conference in San Francisco.

Inovio Biomedical Corp., of San Diego, said its partner Tripep AB, of Huddinge, Sweden, plans to file with Swedish regulators a modified application designed to permit clinical testing of its DNA vaccine, ChronVac-C, in subjects already infected with hepatitis C virus instead of healthy volunteers, as per the original application. Tripep plans to begin the Phase I/II study late this year. The product is administered using Inovio's MedPulser DNA delivery system.

• Intarcia Therapeutics Inc., of Emeryville, Calif., said final results from a Phase II study comparing the combination of injectable omega interferon and ribavirin to omega interferon alone in treatment-naïve patients with genotype 1 chronic hepatitis C demonstrated that the combination treatment is well tolerated and shows antiviral activity comparable to published data on the use of alpha interferon plus ribavirin in similar patient populations. Patients in the combination arm had an early viral response of 84 percent, compared to 60 percent in the omega interferon alone arm, and sustained viral response was 36 percent in the combination arm vs. 6 percent in the omega interferon only arm. The 72-week sustained viral response data were presented at the Digestive Disease Week conference in Washington.

Microbia Inc., of Cambridge, Mass., said Phase II data showed linaclotide accelerated colonic transit and improved bowel function in patients with constipation-predominant irritable bowel syndrome. Thirty-six women were enrolled. The data also showed linaclotide was well tolerated with a low incidence of adverse events, as well. Linaclotide is a first-in-class compound currently being developed for the treatment of IBS-C, chronic constipation, and other gastrointestinal disorders. The drug is an agonist of the guanylate cyclase type-C receptor and acts by a different mechanism than agents targeting the serotonergic system. Data were disclosed at the Digestive Disease Week conference in Washington, D.C.

• Nektar Therapeutics Inc., of San Carlos, Calif., reported results of a Phase IIa trial of NKTR-061 (inhaled Amikacin) showing that the adjunctive use of aerosol antibiotics with systemic therapy might be effective in treating in mechanically ventilated patients with hospital-acquired Gram-negative pneumonia. NKTR-061 was developed using Nektar's micropump technology to deliver aerolosized antibiotics to the deep lungs, both within and outside of a ventilator system. Data were presented at the American Thoracic Society International Conference in San Francisco.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., began a 60-patient, randomized and open-label Phase II trial to evaluate the preliminary safety and efficacy of topical Dermacyn wound care compared to systemic oral antibiotics for mild diabetic foot infections. Its primary efficacy endpoint will be clinical cure or improvement of infection. The company expects results next quarter, followed by two larger, pivotal Phase III trials. Dermacyn is an oxychlorine formulation manufactured using Oculus' Microcyn technology.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., said a new study showed the active ingredient in Amitiza (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation. In two Phase III, multi-center, double-blind, randomized, placebo-controlled trials, 1,171 adults diagnosed with IBS-C were enrolled and received lubiprostone 8 mcg twice daily (783 adults) or placebo (388 adults) over a 12-week period. Those given lubiprostone were nearly twice as likely to achieve overall response compared to those receiving placebo. There was a similar incidence of serious adverse events (1 percent in each group) and related adverse events (lubiprostone 22 percent vs. placebo 21 percent) compared to placebo. Results were presented at the Digestive Disease Week conference in Washington, D.C.