Drug Pipelineline Series: Phase II, 27 Nov - 4 Dec, 2006

CHEMOCENTRYX PRESENTS DATA FROM CROHN'S DISEASE STUDY

ChemoCentryx has presented data from a Phase II study of the company's drug candidate Traficet-EN (CCX282-B), a first-in-class, orally active, anti-inflammatory agent that targets the chemokine receptor known as CCR9, at the 2006 Crohn's and Colitis Foundation of America's annual meeting. New data were presented from a trial in patients with moderate-to-severe Crohn's disease analyzing the effect of Traficet-EN on lowering pro-inflammatory cytokine and chemokine concentrations in the intestine.

BAYER PUBLISHES RESULTS OF ANTICOAGULANT STUDY

Bayer has announced that results of a Phase II trial of the novel oral anticoagulant rivaroxaban, a direct Factor Xa inhibitor, have been published in Circulation. In the trial, rivaroxaban demonstrated that it may have similar safety and efficacy to subcutaneous enoxaparin (the current standard), for the prevention of venous thromboembolism (VTE) in patients undergoing elective total hip replacement surgery.

The publication completes the Phase II program with rivaroxaban for the prevention of VTE after major orthopaedic surgery and contains the full data set from the once-daily dosing trial; results from twice-daily trials in hip and knee replacement surgery have already been published. These data taken together formed the basis of the decision to initiate the Phase III program with rivaroxaban for the prevention of VTE after orthopaedic surgery using a once-daily dosing regimen.

Cleveland BioLabs Initiates Phase II Hormone-Refractory Prostate Cancer Trial for Curaxin CBLC102

Cleveland BioLabs, Inc. announced the initiation of its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer at the Cleveland Clinic and Case Western Reserve University Hospital.
Curaxin CBLC102 is a safe, oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models, and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal cell carcinoma (a highly fatal form of kidney cancer), and soft-tissue sarcoma. The FDA permitted Cleveland BioLabs to advance directly to Phase II studies, based on CBLC102's historic safety profile.

Sangamo BioSciences Initiates Phase 2 Clinical Trial of Novel Therapy for Diabetic Neuropathy

Sangamo BioSciences, Inc. announced that the company has initiated a multi-center Phase 2 clinical trial of SB-509 for diabetic neuropathy (DN). The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF™), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene.

Phase II Data Shows Ovation's Novel Compound Clobazam to Be Well Tolerated in Patients With Catastrophic Epilepsy

Results from the first study in the United States designed to evaluate the safety and efficacy of clobazam as adjunctive therapy in patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy, demonstrated that clobazam is well tolerated. In the trial, clobazam was shown to be effective in significantly reducing drop (or atonic) seizures, the most debilitating of the LGS seizure types, which can result in severe trauma to the brain and body, by 85.3 percent compared to baseline (in the high dose group versus 12 percent in the low dose group; P=.0001). Adverse events leading to the discontinuation of clobazam were rare. Data were presented at the North American Regional Epilepsy Congress.
This phase II, multi-center, randomized, double-blind, dose-finding clinical trial was the first study conducted in the U.S. to evaluate the safety and efficacy of clobazam as adjuvant therapy in patients with LGS. Sixty-eight patients (ages 2 to 26 years) with LGS were randomized to two treatment groups with a low dose (target of 0.25 mg/kg/day) of clobazam or a high dose (target of 1.0 mg/kg/day) for a total treatment duration of up to 10 weeks.

EPIX Announces Full Results from Phase 2a Clinical Trial of EP-2104R Presented at RSNA Annual Meeting

EPIX Pharmaceuticals, Inc. announced the results from a Phase 2a clinical trial of EP-2104R, a novel fibrin-binding thrombus (clot) imaging agent, as presented during an oral presentation at the Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois. The results of the Phase 2a trial found that EP-2104R was able to detect blood clots not previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously seen on MRI. Blood clots are a major underlying cause of several diseases including deep vein thrombosis, pulmonary embolism, heart attack and stroke, and identifying a minimally invasive method for detecting clots would address a substantial medical need.