AVGR Working Towards Vision, MRNS On Track, CCXI On The Watch

(RTTNews) - Avinger Inc. (AVGR) has completed enrollment of its VISION clinical study, which is designed to evaluate the safety and efficacy of Pantheris system to aid in the removal of plaque from diseased lower extremity arteries.

In July 2014, the FDA granted Avinger an investigational device exemption, or IDE, for Pantheris, and the company commenced enrollment of a 133-patient trial in the U.S. and Europe.

The company expects to present interim 30-day data from the VISION trial in the second quarter and six-month data in the fourth quarter of 2015. If all goes well as planned, the company plans to file a 510(k) application with the FDA in the second half of 2015.

AVGR closed Thursday's trading at $10.45, up 4.50%.

ChemoCentryx Inc. (CCXI), which initiated a clinical trial of CCX872 in patients with non-resectable pancreatic cancer earlier this month, plans to report initial data from the trial in the second half of 2015.

The company said it remains on track to complete enrollment in a phase II study of CCX168 in Europe in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), dubbed CLEAR, this year.

ChemoCentryx is also gearing up its preparations to initiate a phase III trial of CCX140 in patients with diabetic nephropathy in 2015.

CCXI closed Thursday's trading at $8.06, up 4%.

Marinus Pharmaceuticals Inc. (MRNS) anticipates releasing initial data from a phase 2 proof-of-concept, open-label clinical trial of its drug candidate Ganaxolone for PCDH19 female pediatric epilepsy during 2015.

The company's phase 3 clinical trial of Ganaxolone in adults with drug-resistant focal onset epileptic seizures is enrolling patients, and top-line data are anticipated in the first quarter of 2016.

A phase 2 proof-of-concept investigator-sponsored clinical trial of Ganaxolone in Fragile X Syndrome that is being conducted, under a grant that funds the majority of the program, by the MIND Institute in collaboration with Marinus, is enrolling participants. This study is expected to be completed during 2015.

MRNS closed Thursday's trading at $10.41, up 4.10%. In after-hours, the stock was down 5.38% at $9.85.

Pfizer Inc.'s (PFE) phase 4 study evaluating Lyrica Capsules CV as a treatment for adolescents with fibromyalgia has failed to meet the primary endpoint as there was not a statistically significant difference between the drug and placebo in mean pain score.

The phase 4 study was conducted to fulfill a post-marketing commitment required by the FDA when Lyrica was approved for the management of fibromyalgia in June 2007.

Lyrica is approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), neuropathic pain associated with spinal cord injury, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures.

Worldwide sales of Lyrica totaled $5.17 billion in 2014 compared to $4.59 billion in 2013.

Theravance Biopharma Inc. (TBPH) has initiated a phase 2b study evaluating its drug candidate Velusetrag (TD-5108) for the treatment of patients with gastroparesis and other gastrointestinal motility disorders.

The phase 2b study will evaluate three dose levels of Velusetrag (5, 15, and 30 mg once daily) against placebo for 12 weeks of therapy.

Velusetrag is being developed by Theravance Biopharma in collaboration with Alfa Wassermann.

TBPH closed Thursday's trading 4% higher at $19.25.