• Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-797, a selective, orally active inhibitor of p38 MAP kinase. The compound initially will be evaluated in dose-escalation studies in healthy volunteers for safety, exposure and inhibition of mechanism-related biomarkers. Pending positive results, it likely would be tested in patients with inflammatory diseases.

• Avantogen Oncology Inc., of Los Angeles, said the FDA accepted its investigational new drug application for RP101 in pancreatic cancer. The company is planning a Phase II, randomized, placebo-controlled trial to test RP101 in combination with gemcitabine chemotherapy vs. gemcitabine chemotherapy alone, in patients with metastatic pancreatic cancer. The primary endpoint will be survival at six months, while tumor response rate and progression-free survival will be evaluated as secondary endpoints. Patient accrual is targeted to start early in 2007.

• AVI BioPharma Inc., of Portland, Ore., said preliminary observations from the APPRAISAL study evaluating Resten-MP delivered intravenously via microparticle technology in conjunction with placement of one or more bare-metal stents, showed that the product is effective at delivering the drug component, AVI-4126, to the sites of vessel injury. AVI and partner Bloomington, Ind.-based Cook Group anticipate advancing the program in restenosis. AVI signed a potential $100 million deal with Cook in March to license its Neugene antisense platform for down-regulating c-myc gene expression in the field of cardiovascular disease. (See BioWorld Today, March 14, 2006.)

• Bionovo Inc., of Emeryville, Calif., said the FDA accepted the protocol for its Phase I/II trial with BZL101, the company's lead candidate for metastatic breast cancer. The study is designed to determine the maximum tolerated dose and to evaluate the safety and efficacy of BZL101. Recruitment and testing will take place at 10 clinical sites in the U.S., and Bionovo expects to begin patient enrollment early in the first quarter of 2007.

• CytRx Corp., of Los Angeles, said its lead drug candidate, arimoclomol, was granted orphan status in amyotrophic lateral sclerosis by the European Commission. Arimoclomol, an orally administered small molecule, is believed to work by stimulating a normal cellular protein repair pathway through the activation of molecular chaperones. It previously was granted orphan drug status by the FDA.

• Genta Inc., of Berkeley Heights, N.J., completed target patient accrual in a randomized Phase III study of Genasense plus chemotherapy in previously untreated patients with acute myeloid leukemia. The primary endpoint is a comparison of overall survival, and secondary endpoints include the percentage of complete remission, remission duration, safety and other assessments. Data are expected in 2007. Genasense (oblimersen sodium) also was developed in relapsed or refractory chronic lymphocytic leukemia, and the company submitted a new drug application for the drug in that indication in combination with fludarabine and cyclophosphamide. The FDA on Monday extended the review period for the NDA for 90 days. (See BioWorld Today, Dec. 30, 2005.)

• Hana Biosciences Inc., of South San Francisco, started a multicenter Phase II trial with Talvesta (talotrexin) for injection in adult patients with relapsed or refractory acute lymphoblastic leukemia. The main objective of the Phase II portion of an ongoing Phase I/II open-label study is to evaluate the complete remission rate of Talvesta in relapsed or refractory ALL patients. Secondary objectives are to evaluate the safety and tolerability of Talvesta in this setting, as well as duration of complete remission and overall survival. Data from the Phase I portion will be presented during the 48th Annual American Society of Hematology meeting in December.

• Human Genome Sciences Inc., of Rockville, Md., reported the interim results of two Phase II trials to evaluate the efficacy and safety of Albuferon (albumin-interferon alpha 2b) in combination with ribavirin in patients with chronic hepatitis C. The results were presented in Boston at the annual meeting of the American Association for the Study of Liver Diseases, and suggested that Albuferon may offer efficacy at least comparable to pegylated interferon for treatment-na ve patients, with similar safety, fewer injections and the potential to improve health-related quality of life. In the Phase II nonresponder study at the final 24-week follow-up point, after the end of 48 weeks of treatment, researchers found a low rate of relapse and an overall rate of sustained virologic response of 21 percent in the 900-mcg and 1200-mcg Albuferon treatment groups, in a patient population that was heavily pretreated.

• MacuSight Inc., of Union City, Calif., started a Phase I study of its lead product candidate in patients with wet age-related macular degeneration. The trial will enroll 30 patients, and is designed to evaluate the safety and tolerability of MacuSight's formulation of sirolimus (rapamycin) when administered in various doses through two different types of ocular injections.

• Portola Pharmaceuticals Inc., of South San Francisco, started a Phase I trial in healthy volunteers with the intravenous formulation of its ADP receptor antagonist, an antiplatelet agent being studied for cardiovascular indications. Portola recently completed its first Phase I study in healthy volunteers, in which the oral formulation of the same compound was found to be well tolerated and showed dose-dependent platelet inhibition. Portola's compound is believed to be the only ADP receptor antagonist with both I.V. and oral formulations in clinical development, the company said.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. reported positive data from a Phase III program of its Interleukin-1 (IL-1) Trap in CAPS (CIAS1-related autoinflammatory periodic syndromes), a rare, chronic disease. Both studies in the program met their primary endpoints of change in disease activity, which was measured using a composite symptom score composed of a daily evaluation of fever/chills, rash, fatigue, joint pain and eye redness/pain. The company intends to file a biologics license application in the second quarter of 2007, following completion of a 24-week open-label extension phase. The IL-1 Trap has received orphan drug status and fast-track designation in the U.S.

• Speedel Holding Ltd., of Basel, Switzerland, started a Phase IIa trial with the renin inhibitor SPP635 for hypertension. The compound is the first of a next generation of renin inhibitors following Speedel's lead product, SPP100 (aliskiren, Tekturna), which is partnered with Novartis AG, also of Basel, and awaiting marketing approval from the FDA and the European regulators.

• Urigen NA, of Burlingame, Calif., said U101, its drug for chronic pelvic pain of bladder origin, did not meet its primary endpoint in a 90-patient Phase II study, though the company intends to proceed with development of the product. The primary endpoint was improvement in pain and urgency at the end of the study, as monitored by the PORIS (Patient Overall Rating of Improvement of Symptoms) questionnaire. The drug was found to be well tolerated, with an adverse event profile comparable to that of placebo. Urigen said it believes overall results might have been compromised by issues of patient selection, and will incorporate protocol changes for subsequent trials. Last month, Urigen signed a merger agreement with Burlingame, Calif.-based Valentis Inc., which is expected to close in the first quarter. (See BioWorld Today, Oct. 10, 2006.)

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