• Celgene Corp., of Summit, N.J., said its wholly owned subsidiary, Celgene International Sarl, presented updated data from a Phase I/II trial of Revlimid (lenalidomide) plus melphalan and prednisone in elderly patients with newly diagnosed multiple myeloma. After two years, the overall survival rate was 91 percent (p<0.05) and the event-free survival rate was 75 percent (p<0.034). A confirmatory Phase III trial is ongoing. Revlimid is FDA-approved for refractory multiple myeloma in combination with dexamethasone and for certain myelodysplastic syndromes; it is under European regulatory review for both indications. The data were presented at the 12th Congress of the European Hematology Association in Vienna, Austria.

• Debiopharm Group, of Lausanne, Switzerland, reported results from a Phase I study once-monthly subcutaneous injections of Debio 9902 SR implants in healthy volunteers, showing that sustained levels of Huperzine A, the active metabolite of the drug, were observed for up to four weeks and that Debio 9902 was well tolerated. Those results were presented at the Alzheimer's Association International Conference on the Prevention of Dementia in Washington. Also at the conference, Debiopharm presented results from a separate Phase IIa study showing that the oral formulation of Debio 9902 in mild to moderate AD patients resulted in improvements on three efficacy scales: the assessment cognitive subscale (ADAS-cog), the Mini Mental State Examination (MMSE) and the Neuropsychiatric Inventory Questionnaire (NPI-Q). Debio 9902 is an acetylcholinesterase inhibitor that is transformed non-enzymatically into Hup A, its active compound.

• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., presented results from a Phase III trial evaluating FROVA (frovatriptan succinate) 2.5 mg tablets as a six-day preventative treatment in women with difficult-to-treat menstrual migraine (MM). The data demonstrated that FROVA significantly reduced the frequency and severity of MM as well as the disabilities related to them. In the trial, women were randomized in the double-blind study to receive FROVA 2.5 mg once a day, FROVA 2.5 mg twice a day or placebo (ratio 3:2:3). FROVA once or twice daily significantly improved the number of headache-free perimenstrual periods (PMPs) compared to women who received placebo. FROVA also significantly reduced the incidence of severe migraines and therefore tended to improve the ratio of severe to mild headache compared to women who received placebo. The study's primary endpoint was the number of completely headache-free PMPs. FROVA therapy significantly improved the number of headache-free PMPs per patient (0.92 [twice daily], p < 0.0001; 0.69 [once daily], p=0.009) vs. 0.42 (placebo). The incidence of severe headache was significantly less with FROVA once daily (44 percent; p=0.007) and twice daily (40 percent; p=0.0003) compared with placebo (58 percent), lowering the ratio of severe to mild migraine from 11:1 with placebo to 4:1 [once daily] and 2:1 [twice daily] with FROVA. The results were presented at the annual meeting of the American Headache Society in Chicago, and were from the second of the two successful Phase III trials evaluating the efficacy and safety of FROVA in MM prophylaxis.

• Erimos Pharmaceuticals Inc., of Raleigh, N.C., began patient dosing in a weekly-dose Phase I study of terameprocol (EM-1421), a synthetic tetra-methylated derivative of nordihydroguaiaretic acid in development for solid tumors that are unresponsive to conventional therapy. The 24-patient trial will determine the maximum tolerated dose of the drug, when administered as a weekly 24-hour infusion. Erimos has exclusive rights to terameprocol from Johns Hopkins University for use in various diseases.

• Favrille Inc., of San Diego, presented interim data from a small, ongoing, European Phase II trial of the patient-specific immunotherapy FavId in patients with all types of indolent B cell non-Hodgkin's lymphoma (NHL). Treatment with FavId resulted in clinical responses and established the feasibility of conducting larger trials in Europe. Favrille expects primary endpoint data from an ongoing pivotal Phase III trial of FavId following Rituxan in follicular B cell NHL in the fourth quarter of 2007. The Phase II data were presented at the 12th Congress of the European Hematology Association in Vienna, Austria.

• Immunomedics Inc., of Morris Plains, N.J., presented data at the 12th Congress of European Hematology Association in Vienna, Austria, showing positive responses in patients with non-Hodgkin's lymphoma treated with a new radioimmunotherapy using epratuzumab to deliver toxic radiation directly to lymphoma cells in small fractions. Epratuzumab is a humanized monoclonal antibody that targets the CD22 antigen on B-cells, including malignant B-cells. According to the presentation, 54 patients were evaluated with an overall objective response rate of 59 percent and a complete response rate of 43 percent. Moreover, there were six complete responders who remained disease-free for more than one year, including four continuing for more than two years. Both the objective and complete response rates appeared to increase with higher cumulative doses. Objective responses occurred for 41 percent of patients at the lowest total doses of 5-10 mCi/m(2), compared to 55 percent in the groups receiving 15-20 mCi/m(2), 63 percent in the 22.5-37.5 mCi/m(2) cohorts, and 90 percent receiving the highest cumulative doses of 37.5-45 mCi/m(2). Similarly, complete responses occurred for 29 percent of patients in the 5-10 mCi/m(2) total dose groups, compared to 45 percent at 15-20 mCi/m(2), 44 percent at 22.5-37.5 mCi/m(2), and 60 percent at 37.5-45 mCi/m(2). Also, 64 percent of patients who had received prior rituximab-containing regimens responded to (90)Y-epratuzumab, as well as 41 percent of patients with prior bone marrow transplant.

• KaloBios Pharmaceuticals Inc., of Palo Alto, Calif., has begun dosing subjects in a U.S. Phase I study of its second drug candidate, KB001, in healthy volunteers. KB001 is a Humaneered PEGylated monoclonal antibody fragment for the treatment of life-threatening Pseudomonas aeruginosa infections, a common problem of cystic fibrosis and mechanically ventilated patients. KB001 targets and neutralizes the PcrV protein of the Type III secretion system of the Pseudomonas bacterium, which directly inhibits its toxic effects. The trial is a placebo-controlled, single-dose, dose escalation study in healthy adult volunteers, and will enroll approximately 20 patients at a single medical center in Honolulu. The endpoints for the study will be markers for safety and pharmacokinetics.

• NeurogesX Inc., of San Carlos, Calif., has completed enrollment in study C117, a second Phase III clinical trial of its lead product candidate NGX-4010, for the treatment of postherpetic neuralgia. NGX-4010 is a dermal patch designed to manage peripheral neuropathic pain. Previously completed Phase III trials showed that a single, 30- or 60-minute treatment with NGX-4010 applied directly to the pain site may provide relief for up to three months. C117 is a randomized, double-blind, controlled study that has enrolled more than 400 patients at study sites in the U.S. and Canada. The upcoming study will evaluate a 60-minute treatment.

• Neuro-Hitech Inc., of New York, said its Phase II clinical trial of Huperzine A is fully enrolled, with 210 subjects being evaluated at 35 U.S. trial sites. The 24-week trial is a randomized, placebo-controlled study designed to evaluate the compound's safety and efficacy in improving cognitive function of Alzheimer's patients. The study design uses a three parallel-arm approach, with each group administered either Huperzine A twice daily in an escalating 200-mcg dose, Huperzine A twice daily in an escalating 400-mcg dose, or a placebo. The primary endpoint is the ADAScog score at 16 weeks. After 24 weeks, patients are offered the option to participate in an open-label extension for up to a total of 32 weeks while placebo patients are offered active drug at 16 weeks.

• NovaCardia Inc., of San Diego, said preliminary results from a pilot Phase III trial of KW-3902, an adenosine A1 receptor antagonist in development for acute congestive heart failure, indicate a strong trend toward efficacy for the 30-mg dose. Patients treated with KW-3902 experienced a higher rate of improvement in dyspnea, a common symptom of CHF, compared to the placebo group, and the results also showed that the drug enhances diuresis and mitigates deterioration of renal function that is often experienced by patients undergoing standard treatment. Data were presented at the European Society of Cardiology's Heart Failure Congress in Hamburg, Germany.

• Oncolytics Biotech Inc., of Calgary, Alberta, started enrolling patients in its UK trial of Reolysin in combination with gemcitabine in patients with advanced cancers, including pancreatic, lung and ovarian. The study, designation REO 009, has two components. The first is an open-label, dose-escalation study of Reolysin given intravenously with gemcitabine every three weeks, while the second part will include the enrollment of a further 12 patients at the maximum dosage of Reolysin in combination with a standard dosage of gemcitabine. Oncolytics said the trial is one of three expected to start this year to examine the role of Reolysin, the company's formulation of the human reovirus, in combination with chemotherapy.

• Orchestra Therapeutics Inc., of Carlsbad, Calif., formerly known as The Immune Response Corp., presented data from a Phase II open-label study of the T-Cell Receptor (TCR) peptide vaccine NeuroVax in relapsing-remitting multiple sclerosis. The data showed NeuroVax increased levels of TCR-specific T cells and expanded the capacity of the T cells to recognize TCRs expressed by potentially pathogenic T cells. NeuroVax currently is being studied in a Phase II trial. The data were presented at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting.

• Othera Pharmaceuticals Inc., of Exton, Pa., said the first patient was dosed in its 198-patient Phase II OMEGA (OT-551 Multicenter Evaluation of Geographic Atrophy) trial of OT-551 eye drops. Geographic atrophy is the advanced form of drug age-related macular degeneration (AMD). The primary endpoint for the three-arm, two-year study will be the rate of change from baseline in the area of geographic atrophy. OT-551 is a small molecule designed to act through multiple pathways to down-regulate the disease-induced overexpression of nuclear factor kappa B (NF-kB) and to reduce oxidative stress.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., initiated a Phase II/III trial evaluating the effect of the combination of Trimesta (oral estriol) and Copaxone (glatiramer acetate, Teva Pharmaceuticals Inc.) on relapse rates in 150 women with relapsing-remitting multiple sclerosis. In a Phase II single-agent trial, Trimesta reduced the volume and number of lesions and improved cognitive testing scores. The drug is marketed in Europe and Asia for hot flashes, and its current trial is supported by a $5 million grant from the National Multiple Sclerosis Society, with support from the National Institutes of Health. Pipex shares (OTC BB:PPEX) lost 10 cents Monday to close at $3.90.

• Sunesis Pharmaceuticals Inc., of South San Francisco, reported positive interim data from a Phase I study of SNS-595 in relapsed and/or refractory acute leukemias, showing that five out of 10 patients in the 50-mg/m2 and 60-mg/m2 dose cohorts experienced bone marrow blast reductions of more than 95 percent, including one complete remission with incomplete platelet recovery, one complete remission with partial but incomplete recovery of normal hematopoietic blood elements and one partial response. In the twice-weekly 40 mg/m2 dose cohort, one of three patients had blast reduction of more than 95 percent and that patient achieved a complete remission. Data were presented at the European Hematology Association meeting in Vienna, Austria. At that meeting, Sunesis also presented non-clinical results of SNS-032, a cyclin-dependent kinase inhibitor, showing that the candidate has greater selectivity and cellular potency to other CDK-targeting agents, such as flavopiridol, when analyzed in a cancer cell line in bovine and human serum to assess mechanism of action and target modulation.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said data from a Phase II trial of Cloretazine (VNP40101M) as a single agent in a subset of 59 elderly patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome and unfavorable cytogenetics showed an overall response rate of 25 percent. Response by diagnosis showed that 48 percent of the 21 patients with de novo AML showed a response, along with 30 percent of the 10 patients with MDS and 7 percent of the 28 patients with secondary AML. Twelve patients died within 30 days of receiving induction treatment, and the majority of early death was in patients with secondary AML and due to disease progression. Data were presented at the European Hematology Association meeting in Vienna, Austria.

• Viventia Biotech Inc., of Toronto, started patient dosing for its Phase I trial of oncology candidate VB6-845, a humanized antibody fragment targeting EpCAM fused with the company de-immunized form of cytotoxic protein Bouganin. The study, which will enroll 40 to 50 patients with advanced EpCAM-positive epithelial cancers, is designed to establish safety and preliminary efficacy. Early results are expected later this year.