• Affymax Inc., of Palo Alto, Calif., reported results from a Phase II study showing that 182 chronic renal failure patients with anemia using Hematide once every four weeks for up to 23 months successfully maintained average hemoglobin levels within an 11 g/dL to 12 g/dL target range. Results were presented at the American Society of Nephrology meeting in Philadelphia.

• Bavarian Nordic A/S, of Kvistgard, Denmark, completed a safety report from a large Phase II study with Imvamune in HIV-infected subjects, which confirmed an excellent safety profile for the smallpox vaccine. The safety report will be submitted to the FDA, which will trigger a $25 million milestone payment under a U.S. government contract. The clinical safety report constitutes a major part of the data package that will be used to potentially support the use of Imvamune in a declared emergency. The Phase II study was done in support of using the vaccine in individuals otherwise contraindicated to receive conventional vaccinia vaccines.

• BioCis Pharma Ltd., of Turku, Finland, has begun Phase IIa trial of ProtoCure emulsion cream, its topical drug for dermatology. The double-blind, vehicle-controlled study is designed to evaluate the tolerability and efficacy of the topical product in a total of 18 subjects with mild to moderate forms of atopic dermatitis. The subjects will apply ProtoCure emulsion cream up to four weeks to the skin areas affected by the disease.

• Cytochroma, of Markham, Ontario, announced positive comparative data on a vitamin D analogue, CTA018. In preclinical models, CTA018 showed advantages over two marketed vitamin D hormone replacement therapies calcitriol and paricalcitol (Zemplar). Data were presented at the annual meeting of the American Society of Nephrology in Philadelphia.

• Dendreon Corp., of Seattle, said Phase I data of Neuvenge (lapuleucel-T), an active cellular immunotherapy, in 37 patients with HER2/neu-positive cancer who have failed standard therapy, showed that the treatment was generally well tolerated and the median T-cell proliferative stimulation index in response to the immunizing antigen increased from 1.3 at baseline to 19.7 at week 4, 19.4 at week 8 and 20.7 at week 16. Five patients had prolonged disease stabilization ranging from 48 weeks to 94 weeks, without the addition of other cancer therapy besides bisphosphonates, and one patient experienced a partial response lasting about six months. Data also showed that immune monitoring performed in three of four patients who underwent repeat treatment suggested an increase in immune response following the booster treatments. Those results were presented at the Chemotherapy Foundation Symposium in New York.

• Diamyd Medical AB, of Stockholm, Sweden, said six European countries have approved the initiation of a Phase III study with the Diamyd diabetes vaccine for Type I diabetes. The study will include children and adolescents with Type I diabetes in the Netherlands, UK, Finland, Slovenia, Spain and Sweden. Diamyd also is conducting a Phase III study in the U.S. The studies apply to people diagnosed within the last three months.

• Living Cell Technologies Ltd., of Sydney, Australia, said early results of its Phase I/IIa trial of DiabeCell in insulin-dependent (Type I) diabetes showed that, of the initial five patients implanted with 5,000 islet equivalents dose of DiabeCell, four have had a second dose and two patients have been observed for more than 12 months. Of the two patients who have been followed for a year, patient one has maintained HbA1c at the ideal level of 6.7 percent with less insulin (daily-dose requirements reduced by 25 percent to 46 percent) and patient two did not require insulin for five months after the first implant and now uses 36 percent less insulin daily than before the implant. DiabeCell is an encapsulated porcine insulin-producing cell product.

• Morria Biopharmaceuticals plc, of London, said data from a Phase II study of MRX-4, given as an intranasal spray formulation to patients with allergic rhinitis demonstrated a statistically significant therapeutic effect vs. placebo. MRX-4 efficacy was assessed by its reduction of six clinical categories: rhinorrhea, nasal itching, sneezing, frontal headache, nasal congestion and ear/palate itching.

• Oncolytics Biotech Inc., of Calgary, Alberta, said a Phase II trial of intravenous Reolysin in patients with bone and soft tissue sarcomas metastatic to the lung is showing that it is well tolerated with promising results. To date, 35 patients have been enrolled and 29 are evaluable; 21 percent of the evaluable patients experienced stable disease for more than 16 weeks. The investigators concluded that the study has met its established objectives and that enrollment will continue to the full 52 patients.

• Pervasis Therapeutics Inc., of Cambridge, Mass., said data from Phase I and Phase II trials involving 65 patients found that treatment with Vascugel was safe with a lower incidence of local wound infection, access intervention and acute thrombosis compared to placebo; 6.5 percent and 10.9 percent for the Vascugel-treated group at two and four weeks, respectively, vs. 21.1 percent and 21.1 percent for the control group. In the arteriovenous graft intent-to-treat population, treatment with Vascugel showed a statistically significant decrease (5.3 percent) in the incidence of early complications compared to placebo (10.5 percent) at two weeks and that positive trend continued at four weeks. Vascugel is an allogeneic cell therapy product designed to restore natural repair and regeneration pathways in the vasculature. Data were presented at the American Society of Nephrology meeting in Philadelphia.

• Poniard Pharmaceuticals Inc., of South San Francisco, said top-line results from its Phase I trial of an oral formulation of picoplatin in patients with solid tumors showed that it achieves linear and dose-dependent plasma exposure when given by the oral route. The results demonstrated that exposure to orally administered picoplatin was linear at doses below 200 mg, and that maximum exposure to orally administered picoplatin was achieved at doses of 200 mg or greater indicating sufficient bioavailability to support further clinical studies.

• Repligen Corp., of Waltham, Mass., has begun a Phase IIb trial to evaluate the use of RG2417, an oral formulation of uridine, in patients with bipolar depression. In the multicenter, randomized, double-blind, placebo-controlled study, approximately 150 patients with bipolar depression will receive either RG2417 or placebo twice daily for eight weeks. The study is designed to assess the safety and efficacy of RG2417.

• Scolr Pharma Inc., of Bothell, Wash., said top-line results from its pivotal Phase III trial of 12-hour CDT 600-mg extended-release (ER) ibuprofen met both co-primary endpoints and had no significant adverse events. The study was designed to test multiple doses of the product in dental pain following third molar extraction. The first primary endpoint was defined as analgesic efficacy for the eight-hour to 12-hour period after the first dose compared to placebo, while the second primary endpoint measured the durability of effect of Scolr's formulation by the proportion of subjects in the ibuprofen ER group with meaningful improvement in pain intensity from baseline at all three assessment periods of 24 hours, 36 hours and 48 hours. The final clinical study report is expected in early 2009.

• Sunesis Pharmaceuticals Inc., of South San Francisco, said data from three clinical trials of its lead drug candidate, voreloxin (formerly SNS-595) warranted further development of the compound. Data from a completed Phase I dose escalation trial of voreloxin as a single agent in acute leukemias (N = 73) showed that single-agent voreloxin was generally well tolerated, with the most frequently observed dose-limited toxicity being reversible grade 3/4 oral mucositis. Initial data from an ongoing Phase Ib/II study testing voreloxin in combination with cytarabine showed that of 11 evaluable patients in the first three cohorts, three have achieved a complete remission (one at 20 mg/m2 of voreloxin and two at 34 mg/m2 of voreloxin). Six patients were enrolled in cohort 4 (50 mg/m2 of voreloxin); one had complete remission, and one had a complete remission without full platelet recovery. Data were presented at the Chemotherapy Foundation Symposium in New York.

• Theratechnologies Inc., of Montreal, said 26-week data from a combined analysis of both its Phase III trials of tesamorelin in HIV-associated lipodystrophy indicated that a daily administration of 2 mg of the drug is beneficial in reducing visceral adipose tissue in HIV-infected patients regardless of the type of antiretroviral therapy regimen used to treat HIV infection. Overall, the VAT decreased from baseline by 13 percent in tesamorelin-treated patients, while the placebo group increased VAT by 2.3 percent overall from baseline. Data from the study, which initially were reported in June, were presented at the International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV in London. (See BioWorld Today, June 19, 2008.)