February's top stories: Cerulean's dosing in therapy trial, Novartis Phase II study

Cerulean Pharma began dosing in a Phase II clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) for treatment of relapsed ovarian cancer, while Novartis reported that the Phase II study evaluating its investigational oral compound LDE225 (sonidegib) in advanced basal cell carcinoma (BCC) met its primary endpoint. Drugdevelopment-technology.com wraps-up the key headlines from February 2014.


Cerulean

Cerulean starts dosing in phase 2 combination therapy trial for ovarian cancer treatment

Cerulean

US-based Cerulean Pharma dosed the first patient in a phase 2 clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) for the treatment of relapsed ovarian cancer.

The open-label single-arm phase 2 combination therapy trial is being carried out at Massachusetts General Hospital (MGH) and the affiliated Harvard teaching hospitals under the direction of principal investigator Dr Carolyn Krasner.

The trial is designed to investigate the rate of progression-free survival at six months (PFS6) using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria in relapsed ovarian cancer patients treated with a combination of Avastin and CRLX101.

Bayer begins patient enrolment in Phase III trial of colorectal cancer drug regorafenib

Bayer

Bayer HealthCare initiated patient enrolment in the COAST trial evaluating regorafenib (Stivarga) tablets in colorectal cancer (CRC) patients with resected liver metastases.

The COAST (Patients with Stage IV COlorectal Cancer treated with Adjuvant Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in A Randomized, Double-blind, Placebo-controlled Phase-III Study) trial is evaluating regorafenib in patients with CRC after curative resection of liver metastases and completion of all planned chemotherapy.

The trial will investigate whether providing oral regorafenib in the adjuvant setting increases disease-free survival (DFS) and overall survival (OS).

Novartis' Phase II study of skin cancer drug sonidegib meets primary endpoint

Novartis

Novartis reported that the Phase II study evaluating its investigational oral compound LDE225 (sonidegib) in advanced basal cell carcinoma (BCC) met its primary endpoint of demonstrating an objective response rate among patients within six months of treatment.

The objective response included complete response (clinically significant tumour response with complete absence of disease) and partial response (clinically significant tumour shrinkage).

The randomised, double-blind BOLT (Basal cell carcinoma Outcomes in LDE225 Trial) Phase II trial was designed to evaluate the safety and efficacy of two oral dose levels of LDE225 (200mg and 800mg) in patients with locally advanced or metastatic BCC, which are subtypes of advanced basal cell carcinoma.

Galapagos completes patient enrolment in Phase II trial of ulcerative colitis drug GLPG0974

Galapagos

Belgium-based clinical stage biotech firm Galapagos completed patient enrolment in a clinical proof-of-concept Phase II trial of GLPG0974 for the treatment of ulcerative colitis, a debilitating inflammatory bowel disease.

A total of 45 patients with mild to moderate ulcerative colitis have been enrolled in the trial, which is designed to evaluate the safety, efficacy, pharmacokinetics and effects on selected biomarkers of GLPG0974 in this patient population.

In the trial, patients are randomised to receive either 200mg of GLPG0974 twice-daily or placebo (2:1 ratio), for a period of 28 days.

Global Genomics achieves important milestone in GLOBAL trial of cardiovascular diseases

Global genomics

US-based life sciences company Global Genomics Group (G3) completed enrolment of the 5,000-patient discovery group of its GLOBAL (Genetic LOci and Burden of Atherosclerotic Lesions) clinical trial, designed to identify disease-related pathways, new drug targets and biomarkers for cardiovascular diseases.

GLOBAL is a pan-omic trial combining genomics, epigenomics, transcriptomics, proteomics, metabolomics, lipidomics and lipoprotein proteomics with coronary computed tomographic (CT) angiography.

Out of the 5,000 patients enrolled in the discovery group, 2,500 patients are in the control group and the remaining 2,500 are in the case group.

La Jolla completes dosing patients in Phase II study of chronic kidney disease

La Jolla

US-based La Jolla Pharmaceutical completed dosing in its Phase II clinical study of GCS-100 for the treatment of chronic kidney disease (CKD) and also collected the final data for assessment of the primary endpoint.

The trial's primary efficacy endpoint is the change in estimated glomerular filtration rate (eGFR) from baseline to the average at day 50 and 57 in each GCS-100 dose group compared with placebo.

According to the company, the trial's primary endpoint will be reached if the difference in eGFR between both GCS-100 dose group and placebo has a significance of less than 10%.

Bayer HealthCare begins new Phase III study of oral anticoagulant rivaroxaban

Bayer HealthCare started its EINSTEIN CHOICE Phase III clinical study aimed at evaluating two doses of its once-daily novel oral anticoagulant rivaroxaban (Xarelto) against acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE).

The study supplements the EINSTEIN Trial Programme, which established in the EINSTEIN Extension study that rivaroxaban 20mg once daily reduces the risk of long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed six or 12 months of anticoagulation treatment.

Around 2,850 patients will be enrolled in the EINSTEIN CHOICE trial, which will be conducted at 250 centres in 30 countries worldwide.

OncoMed begins Phase Ib study of combination therapy for treatment of hepatocellular cancer patients

Oncomed

US-based OncoMed Pharmaceuticals initiated a multi-centre Phase Ib clinical trial involving its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with sorafenib (Nexavar) for the treatment of hepatocellular cancer (HCC).

The Phase Ib trial is a dose escalation study of OMP-54F28 in combination with sorafenib to treat patients with first-line locally advanced or metastatic HCC.

The primary objectives are to assess the safety of the combination regimen and determine a recommended Phase II dose for OMP-54F28 in combination with sorafenib.


Prana's Phase II Huntington's disease study meets primary endpoint

Australia-based Prana Biotechnology reported that its Reach2HD Phase II clinical trial investigating PBT2 as a treatment for Huntington disease succeeded in meeting the primary endpoint of the study.

The trial met its primary safety endpoint and achieved statistically significant improvement in a measure of executive function (cognition), which comprised part of the trial's main efficacy outcome.

The Huntington Study Group carried out the double-blind, placebo-controlled trial at research sites in the US and Australia.

Addex's Phase IIa study in major depressive disorder fails endpoint

Switzerland-based Addex Therapeutics reported that a Phase IIa clinical trial of ADX71149 in anxious depression, conducted by Janssen Research & Development on behalf of its affiliate Janssen Pharmaceuticals, failed to meet the criterion for efficacy signal detection versus placebo.

The multicentre, double-blind, placebo-controlled, flexibly-dosed trial was carried out in patients with major depressive disorder (MDD) with significant anxiety symptoms.

In the trial, ADX71149 was well-tolerated and treatment emergent adverse events reported were similar to those seen in previous clinical trials.