• Emergent BioSolutions Inc., of Rockville, Md., completed a human study to support the expansion of BioThrax (anthrax vaccine absorbed) in post-exposure prophylaxis in people exposed to anthrax. The company also submitted a final study report for that trial to the Department of Health and Human Services, which triggers an $8.8 million payment under the company's $448 million HHS contract signed in September. (See BioWorld Today, Sept. 27, 2007.)

• Epeius Biotechnologies Corp., of San Marino, Calif., opened a Phase II registration trial of Rexin-G in patients with recurrent or metastatic osteosarcoma that is refractory to known therapies. The trial will recruit 20 to 30 patients in 12 to 18 months. Epeius opened a number of Phase I/II trials, following the accelerated approval in the Philippines of Rexin-G in all solid tumors, to test the drug in pancreatic cancer, breast cancer and all types of sarcoma. Rexin-G is a tumor-targeted gene medicine designed to seek out and destroy both primary tumor and metastatic cancers.

• Exelixis Inc., of South San Francisco, said data from its Phase II trial of XL784, a small-molecule inhibiter of ADAM-10 and MMP-2, in patients with albuminuria due to diabetic nephropathy showed that, after 12 weeks of treatment, the baseline normalized ACR (albumin to creatinine ratio) in the XL784 group was 9.9 percent lower than in the placebo group, though those data were not statistically significant. There was a clinically relevant mean ACR reduction from baseline of 23 percent in subjects randomized to XL784. The change in glomerular filtration rate at week 12 was -2.5 ml/min/1.73m2 in the treatment group and -6.2 ml/min/1.73m2 in the placebo group. Data were presented at the nephrology meeting in San Francisco.

• Generex Biotechnology Corp., of Worcester, Mass., treated the first prostate cancer patients in a Phase I trial using its peptide vaccine. The trial, which is being conducted under a collaborative agreement between Generex's Antigen Express division and the Saint Savas Cancer Hospital, is designed to establish specific immunological responses to the AE37 vaccine in 30 patients. AE37 consists of a peptide derived from the tumor-associated HER-2/neu protein that has been modified to increase its ability to stimulate T helper cells.

• Gentium SpA, of Villa Guardia, Italy, said it plans to submit to the FDA an amendment to the Phase III protocol of Defibrotide in hepatic veno-occlusive disease with multi-organ failure, citing recent discussions with the agency. Under the amended protocol, the primary endpoint for the 160-patient study would change from survival at 100 days to complete response as defined by bilirubin < 2 mg/dL and the resolution of multiple organ failure. Survival at 100 days will be evaluated as a secondary endpoint. The company, however, said there will be no changes to the size or trial design because data from both of those endpoints have been collected from the start. To date, the study has enrolled 65 of the expected 80 patients and remains on track to report results in the first half of 2008.

• Insmed Inc., of Richmond, Va., plans to begin a 24-week Phase II trial of Iplex in patients with myotonic muscular dystrophy, based upon promising results from an ongoing dose-escalation study. Up to 70 percent of patients analyzed in that trial have reported improvement in one or more of several symptoms commonly associated with myotonic muscular dystrophy, including cognitive function, gastrointestinal function, muscle pain, arm and leg strength, fatigue and endurance. The upcoming Phase II trial is expected to confirm those positive results. It will include 60 patients and will be powered to detect a 75 meter difference between Iplex and placebo for the change in distance walked during a six-minute walk test.

• Keryx Biopharmaceuticals Inc., of New York, reported preliminary data demonstrating the tolerability and clinical activity of KRX-0401 (perifosine) in patients with refractory, rare sarcomas. Results from the Phase II study showed that perifosine demonstrated a 40 percent overall clinical benefit (stable disease > three months) in subsets of patients with chemotherapy-insensitive sarcomas. Keryx anticipates completing accrual in the study in 2008. Data were presented at the Connective Tissue Oncology Society meeting in Seattle.

• MannKind Corp., of Valencia, Calif., said results from a Phase Ia evaluation of MKC253, a formulation of GLP-1 (glucagon-like peptide) on Technosphere particles delivered using the company's inhaler, showed that GLP-1 plasma concentrations peaked very quickly and GLP-1-induced insulin occurred within six minutes of inhalation of MKC253 in healthy subjects. The study enrolled 26 healthy, male volunteers and was designed to evaluate the tolerability of ascending doses as the primary endpoint and to test pharmacokinetics as the secondary endpoint.

• Medivation Inc., of San Francisco, said its selective androgen receptor modulator, MDV3100, to date, has reduced serum levels of prostate-specific antigen in six patients enrolled in the first two dose groups of its ongoing Phase I/II trial in hormone-refractory prostate cancer. In the lowest dose group, after two months of treatment, PSA levels declined 45 percent to 66 percent, while patients in the second lowest dose group had PSA levels declining 75 percent to 89 percent after one month of treatment. MDV3100 has been well tolerated in both dose groups. The trial is expected to enroll patients in up to seven dose groups, and once a maximum tolerated dose is established, will expand the trial to 20 patients to evaluate the drug for safety, pharmacokinetics, effects on PSA levels and disease progression. Top-line results are expected in 2008.

• Merck & Co. Inc., of Whitehouse Station, N.J., said its human papillomavirus vaccine, Gardasil, prevented 91 percent of cases of persistent infection, low-grade cervical abnormalities and precancers and external genital lesions caused by HPV types 6, 11, 16 and 18, compared to placebo in women ages 24 through 45. Gardasil previously gained approved for girls and women ages 9 through 26 for the prevention of cervical cancer, precancerous or dysplastic lesions and genital warts caused by those HPV types. Data were presented at the papillomavirus conference in Beijing, China.

• Osteologix Inc., of San Francisco, reported positive top-line results from its Phase II trial of NBS101 (strontium malonate), showing that the study met its primary endpoint of significantly decreasing CTX-1, a biomarker for measuring bone resorption activity, in postmenopausal women with lone bone mineral density. The 289-patient study evaluated three dose levels of NBS101 and one dose level of Protelos (strontium ranelate), which is approved in Europe for treating and preventing osteoporosis. Results showed that the reductions in serum CTX-1 compared to the control group were 13.5 percent in the group receiving the lowest dose, 0.75 g, of NBS101, 15.5 percent in the 1-g dose group and 22.2 percent in patients treated at the 2-g dose. When compared to Protelos, the 2-g dose of NBS101 achieved significantly greater reductions of CTX-1, while the 1-g dose produced equivalent results. The study also investigated the drug's effects on bone mineral density (BMD) and showed that, at three months, NBS101 significantly increased lumbar spine BMD at all doses tested, with the most significant increase of 2.66 percent coming from the 2-g dose group. In comparison, Protelos, also a 2-g dose, increased lumbar spine BMD by 1.96 percent.

• Seattle Genetics Inc., of Bothell, Wash., reported positive data from a Phase I study of SGN-35, an antibody-drug conjugate, showing that multiple objective responses were observed at well-tolerated doses of the drug in patients with relapsed or refractory Hodgkin lymphoma and other CD30-positive malignancies. More than 75 percent of patient treated in the trial achieved tumor reductions across all dose levels evaluated, including four with partial responses. Twelve additional patients had stable disease, and seven had progressive disease. SGN-35 has been well tolerated and a maximum tolerated dose has not yet been defined. Data were presented at the Hodgkin lymphoma symposium in Cologne, Germany.

• Speedel Holding Ltd., of Basel, Switzerland, reported results from its Phase III trial showing that SPP100, a renin inhibitor, further lowers proteinuria in diabetic patients, independent of blood pressure, when administered on top of losartan, a standard therapy for diabetic kidney disease. SPP100 was approved by the FDA in March and is sold under the brand Tekturna (under Rasilez in Europe) to treat hypertension, both as a monotherapy and in combination with other antihypertensives. Data were presented at the nephrology conference in San Francisco.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., reported preliminary results from a Phase II of TPI 287, showing that 60 percent of second-line hormone-refractory prostate cancer patients showed clinical benefit. The trial was designed to enroll up to 80 patients who have failed prior docetaxel therapy in two arms: Arm 1 will involve those who received previous benefit from prior docetaxel therapy, and Arm 2 will include patients who had no response with prior docetaxel treatment. Early data showed that the two patients enrolled so far in Arm 1 showed stable disease lasting eight cycles and a confirmed partial response, as measured by prostate-specific antigen. Of the three patients in Arm 2, one progressed on treatment, one discontinued treatment prior to evaluation and one had a confirmed partial response and remains on the study after seven cycles.

• Vivus Inc., of Mountain View, Calif., reached an agreement with the FDA on a special protocol assessment for pivotal Phase III trials of Qnexa in obesity and weight-related comorbidities. The Phase III program will include two studies that will compare Qnexa to placebo during a 56-week treatment period. The first study, EQUIP, will enroll morbidly obese adult subjects with a body mass index (BMI) of 35 or greater with controlled comorbidities. The second study, CONQUER, will enroll overweight and obese adult patients with BMIs from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and Type II diabetes. The co-primary endpoints for both trials will evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5 percent or more.

• Ziopharm Oncology Inc., of New York, said data from an ongoing Phase II study in advanced/unresectable soft-tissue and bone sarcomas show that of 44 evaluable patients, 48 percent of those treated with ZIO-201 had stable disease or better, with a median progression-free survival of 10 weeks. Among the 11 patients enrolled in the study who had not previously received chemotherapy agent ifosfamide, stable disease or better was reported in 64 percent and median progression-free survival has not yet been reached. Data, which were reported at the Connective Tissue Oncology meeting in Seattle, will be used to support plans for a Phase III study of ZIO-201 in 2008.