BLPH Heartened, More Trouble For CTIC, Remicade Biosimilar Gets FDA Panel Nod

(RTTNews) - Axovant Sciences Ltd. (AXON) expects results from a phase II study of Nelotanserin in Lewy body dementia subjects experiencing visual hallucinations in the second half of calendar year 2016.

A phase IIb study of RVT-101 as a potential treatment for Dementia with Lewy bodies is underway, and results are expected in calendar year 2017.

The company plans to initiate a phase II study of Nelotanserin in patients with dementia with Lewy bodies suffering from REM (rapid eye movement) behavior disorder later this quarter. Target enrollment for the study is approximately 50 patients and results are expected in the first-half of calendar year 2017.

Axovant has also reaffirmed that it expects results from a confirmatory phase III study of RVT-101 for the treatment of mild-to-moderate Alzheimer's disease in the second-half of calendar year 2017.

AXON closed Tuesday's trading at $10.07, up 5.89%.

Shares of Bellerophon Therapeutics Inc. (BLPH) surged more than 43% on Tuesday, following positive data from the final analysis of the company's phase II long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension.

According to the trial results, there was sustained benefit to Pulmonary Arterial Hypertension patients who received INOpulse 75 mcg/kg ideal body weight per hour therapy for at least 12 hours per day combined with Long-Term Oxygen Therapy. In Part 1 of the phase II study, the patients showed a mean improvement in 6 minute walk distance (6MWD) of 52.4 meters after 16 weeks of therapy. In Part 2 of the study, after 16 to 32 months of treatment, the patients who remained on iNO 75 for at least 12 hours a day combined with LTOT continued to maintain a mean increase in 6MWD of 55.2 meters, the company noted.

BLPH closed Tuesday's trading at $2.84, up 43.43%.

The FDA has revised the partial hold imposed on CTI BioPharma Corp.'s (CTIC) clinical studies of Pacritinib, its lead drug candidate for primary myelofibrosis, on February 8, 2016, to full clinical hold.

Consequently, the company has withdrawn its New Drug Application for Pacritinib, which was submitted to the FDA on a rolling basis last month.

CTIC closed Tuesday's trading at $0.50, up 13.64%.

South Korea-based Celltrion Inc. has received the FDA panel backing for CT-P13, a proposed biosimilar to Johnson & Johnson's (JNJ) Remicade. CT-P13 is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA.

Celltrion is seeking approval of CT-P13 for the treatment of a variety of serious autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis, among others.

The FDA panel members have voted 21 to three, recommending approval of CT-P13 for all eligible indications.

CT-P13 is already available in the European markets under the name Remsima.

Hospira, now a Pfizer company, has a business cooperation agreement with Celltrion that was signed in 2009 for several biosimilar products, including CT-P13 - a potential biosimilar to Remicade.

Remicade had worldwide sales of $6.56 billion last year compared to $6.87 billion in 2014.

Shares of Nymox Pharmaceutical Corp. (NYMX) gained over 18% on Tuesday, following encouraging results from a phase II trial of fexapotide triflutate in prostate cancer patients.

According to the trial results, cancer progression clinical outcomes were significantly improved in the fexapotide treated patient groups - with much less surgery or radiotherapy required after 18 months.

NYMX closed Tuesday's trading at $2.28, up 16.92%.

ProMetic Life Sciences Inc. (PLI.TO) has a couple of product development and regulatory catalysts up its sleeve to watch out for this year.

The company expects to complete a phase II/III clinical trial of Plasminogen for congenital deficiency and file a Biologic License Application in the second half of this year.

Additionally, ProMetic is scheduled to announce preliminary data from a phase II study of PBI-4050 in patients suffering from idiopathic pulmonary fibrosis next quarter.

The company also plans to report additional clinical data from a phase II study of PBI-4050 in type 2 diabetes patients this quarter.

PLI.TO closed Tuesday's trading at C$2.11, down 5.38%.

Tobira Therapeutics Inc. (TBRA) has completed recruitment in its phase 2a study of Cenicriviroc in obese adults with prediabetes or diabetes and suspected non-alcoholic fatty liver disease.

The top-line 12-week interim analysis from the study, dubbed ORION, is expected in the second quarter of 2016.

TBRA closed Tuesday's trading at $6.55, up 1.55%.

vTv Therapeutics Inc. (VTVT) has completed patient enrollment in its phase 2b clinical trial of TTP399 in patients with Type 2 diabetes.

The study, dubbed AGATA, is a six-month multi-center, double-blind, placebo- and active-controlled, parallel group trial in 180 patients with Type 2 diabetes mellitus on a stable dose of metformin.

The primary efficacy endpoint is change in A1c from baseline to the end of randomized treatment. The company expects to report topline results from the AGATA study in the middle of 2016.

VTVT closed Tuesday's trading at $5.84, down 4.42%.