• Cytokinetics Inc., of South San Francisco, announced data from its Phase I/II trial evaluating its drug candidate SB-743921 in the treatment of patients with Hodgkin or non-Hodgkin lymphoma. SB-743921 is a small-molecule inhibitor of kinesin spindle protein, a mitotic kinesin essential for proper cell division. The primary objectives of the Phase I portion of the trial are to determine the dose-limiting toxicities and the maximum tolerated dose and to assess the safety and tolerability of SB-743921 given on day one and day 15 of a 28-day cycle. The secondary objectives are to characterize the pharmacokinetics of SB-743921 and to evaluate the effect of the drug on biomarkers of cell proliferation in patients with accessible tumors.

• Emergent BioSolutions Inc., of Rockville, Md., said dosing of patients has begun in a U.S. Phase II trial of the company's single-dose oral typhoid vaccine candidate being conducted in healthy adults. The company anticipates that trial results will be available by year-end. The trial is to confirm the safety and immunogenicity of the vaccine, and Phase III trials are expected to begin in 2009.

• Generex Biotechnology Corp., of Worcester, Mass., started dosing patients in its Phase III trial of Generex Oral-lyn oral insulin spray. The six-month study will involve up to 750 patients with Type I diabetes mellitus, with an objective of comparing the efficacy of Generex Oral-lyn and RapidMist diabetes management system with prandial injections of regular human insulin as measured by HbA1c.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said its late-stage candidate, romidepsin, achieved its primary endpoint in a Phase IIb trial in cutaneous T-cell lymphoma, demonstrating an objective disease response rate in 40.3 percent (29 of 72) of evaluable patients who had failed previous therapy. Thirty-three percent (24 of 72) experienced a partial response, and 6.9 percent (five of 72) experienced a complete response. Additionally, 92.3 percent (48 of 52) of patients with pruritis at the outset of the trial had some relief. Those data were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland.

• Inovio Biomedical Corp., of San Diego, said a clinical study of an experimental DNA-based prostate cancer vaccine has reaffirmed that, post-treatment, the therapy is safe and well tolerated. Additional testing validated higher levels of antibody and anti-DOM CD4 responses achieved in patients treated using electroporation. The academic study is a Phase I/II trial of 30 HLA A2+ patients with biochemical failure of prostate cancer. Antibody responses generally were higher in patients treated using electroporation compared to those treated with the DNA vaccine alone without electroporation. Data were presented at the American Society of Gene Therapy annual meeting in Boston.

• Living Cell Technologies Ltd., of Auburn, Australia, said that positive preliminary data from the Phase I/IIa trial of Diabecell, its lead product of encapsulated porcine insulin-producing cells, for insulin-dependent Type I diabetes has encouraged the company to expand the trial and proceed with testing higher doses. There have been no significant adverse effects, and a clinical effect was demonstrated with reduction in daily insulin requirement for up to six months follow-up with satisfactory control of blood glucose. In subsequent implants, the dose of DiabeCell will move up from 5,000 islet equivalents per kilogram body weight (IEQ/kg) to 10,000 IEQ/kg, and the number of patients increased from six to 10.

• Merck Serono International SA, of Geneva, a division of Merck KGaA, and its development partner ZymoGenetics Inc., of Seattle, said a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE) has been initiated. The one-year randomized, double-blind, placebo-controlled international trial will enroll approximately 500 patients with SLE and will evaluate the efficacy and safety of atacicept compared to placebo. The primary efficacy endpoint is the proportion of subjects experiencing a new disease flare, based on BILAG measurements, a scoring system used to assess the status of a patient suffering from SLE with respect to the severeness of the disease, during the treatment period.

• Mesoblast Ltd., of Melbourne, Australia, said the FDA had cleared an investigational new drug submission by its U.S.-based sister company, Angioblast Systems Inc., to commence a Phase II trial of the stem cell platform technology for treating patients with congestive heart failure. A total of 60 patients will be enrolled with 15 patients serving as controls and 45 receiving one of three doses of the company's allogeneic adult stem cells. Study endpoints will include measurement of heart muscle function and improvement in heart failure symptoms at six months and 12 months.

• Micromet Inc., of Bethesda, Md., presented positive data on its CD19-specific BiTE antibody in patients with incurable non-Hodgkin's lymphoma (NHL). In the study, relapsed, NHL patients who previously failed a median of three (and up to 12) conventional therapies were treated with increasing doses of blinatumomab (MT103/MEDI-538) for four to eight weeks. Dose-dependent clinical activity was observed. At the recently completed cohort of 0.06 mg/m2 per day, seven out of seven patients showed either complete or partial responses. Remissions in this and the previous dose cohort continue in all patients, with the longest remission ongoing for more than one year. Most frequent side effects observed so far were lymphopenia, pyrexia and leukopenia. Data were presented at the International Conference on Malignant Lymphomas in Lugano, Switzerland.

• Oncolytics Biotech Inc., of Calgary, Alberta, started patient enrollment in a Phase II trial of intravenous Reolysin in combination with paclitaxel and carboplatin in advanced head and neck cancer patients. The 14-patient study's primary objective is to measure tumor responses and duration of response, as well as to describe any evidence of antitumor activity. The secondary objective is to determine the safety and tolerability of Reolysin, a formulation of the human reovirus, when given in combination with the two chemotherapeutic agents.

• Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, reported positive results from its Phase IIb dose-ranging trial of PAC-113, an antifungal drug candidate. The results demonstrated that PAC-113 is effective in the treatment of oral Candidiasis and compares favorably to the efficacy demonstrated by Nystatin, a current standard of care. PAC-113 is a peptide-based antifungal targeting oral Candida infections in immunocompromised patients. The optimal dose of PAC-113 demonstrated a 34 percent increase in the primary endpoint efficacy level as compared to Nystatin, and a 50 percent increase in the corresponding Intent to Treat analysis. Secondary efficacy endpoints showed similar trends among the three PAC-113 doses and the Nystatin group.

• Pharmacyclics Inc., of Sunnyvale, Calif., showed positive final data from a Phase I/II study of motexafin gadolinium (MGd, Xcytrin) in combination with Yttrium-90 Ibritumomab Tiuxetan (Zevalin), an approved antibody-targeted radiation therapy marketed by Cell Therapeutics Inc., of Seattle, in patients with non-Hodgkin's lymphoma. Eighty-three percent of the 29 patients enrolled in the study were rituximab (Rituxan) refractory patients. Of 28 evaluable patients, 46 percent showed a complete response for an overall response rate of 57 percent. Rituximab refractory patients showed an overall response rate of 86 percent. Adverse events observed were related to bone marrow suppression, a known side effect of Zevalin. Shares of Pharmacyclics (NASDAQ:PCYC) were up 50 cents, or 47.6 percent, to close at $1.55.

• Seattle Genetics Inc., of Bothell, Wash., reported final data from the Phase I trial of SGN-40 in patients with relapsed or refractory non-Hodgkin lymphoma. SGN-40 is a humanized monoclonal antibody being developed under a worldwide collaboration agreement with Genentech Inc., of South San Francisco. Multiple objective responses were achieved, and SGN-40 generally was well tolerated with no maximum tolerated dose identified. The majority of adverse events include fatigue, fever and headache.

• Tranzyme Pharma, of Research Triangle Park, N.C., reported positive results from a Phase IIa study of first-in-class ghrelin agonist TZP-101 in diabetes. Using scintigraphy and a standardized radiolabeled meal, the crossover study assessed the effects of TZP-101 on gastric emptying in 10 patients with long standing Type I or Type II diabetes and severe symptomatic gastroparesis. Data showed that TZP-101 induced a statistically significant reduction in half-emptying time (p=0.043) and latency time (p=0.037) of the solid meal. Gastric emptying of the solid meal was normalized in 30 percent of patients after a single TZP-101 infusion. Half-emptying and latency times for liquids were reduced as well. TZP-101 infusion decreased a cumulative meal-related symptom score in five of eight patients with an overall improvement of 24 percent. Postprandial fullness, the most frequent and severe symptom observed in the study, was reduced by 37 percent. Data were to be presented at the American Diabetes Association annual meeting in San Francisco.

• Trophos SA, of Marseille, France, said it completed enrollment in a 180-patient Phase IIa trial of TRO19622. The study is designed to compare the drug to placebo after six weeks of treatment in patients with painful diabetic neuropathy. The primary endpoint is symptomatic pain relief as measured on the 11-point Likert scale on daily diary, as well as a number of other pain scales. Results from the trial are expected in the fourth quarter.