AERI Rockets On FDA Feedback, ADXS On The Job, ITCI To Report Trial Data In Q3

(RTTNews) - Shares of Aerie Pharmaceuticals Inc. (AERI) were up over 40% in extended trading on Monday after the company announced that it has received the go-ahead from the FDA to change the primary endpoint range of its second phase III registration trial of Rhopressa, dubbed Rocket 2, as the same range in the first registration trial named Rocket 1 where it has demonstrated success in lowering intraocular pressure in patients with glaucoma or ocular hypertension.

Accordingly, the revised primary endpoint of the Rocket 2 trial ranges from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The former range for the primary endpoint of above 20 mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2.

In the first phase III registration trial, known as Rocket 1, the initial results of which were announced in April of this year, Rhopressa demonstrated non-inferiority to the approved product Timolol, and numerical superiority over Timolol at the majority of time points in the primary endpoint ranging from above 20 mmHg to below 25 mmHg.

According to the Baltimore Eye Survey, nearly 80 percent of newly diagnosed glaucoma patients have unmedicated baseline IOPs below 26 mmHg.

Aerie believes that if Rocket 2 results resemble those of Rocket 1, there is a much greater opportunity for success in meeting the clinical endpoint of non-inferiority to Timolol.

AERI closed Monday's trading 1.84% higher at $13.27. In after-hours, the stock was up 40.92% at $18.70.

Advaxis Inc.(ADXS) has submitted a Special Protocol Assessment request to the FDA for a phase III clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer.

The proposed phase III clinical trial is designed as an adequate and well-controlled double-blind, placebo-controlled multinational study of ADXS-HPV administered in the adjuvant setting following concurrent chemoradiation given with curative intent in patients with high-risk, locally advanced cervical cancer for whom recurrence has not yet occurred. Advaxis plans to initiate the phase III trial by the end of 2015.

The FDA may take up to 45 calendar days to provide comments to Advaxis.

ADXS closed Monday's trading at $24.52, up 3.11%.

Apricus Biosciences Inc. (APRI) has enrolled the last patient in a phase 2a proof-of-concept study evaluating its product candidate RayVa in patients with scleroderma who also suffer from Raynaud's Phenomenon.

The company expects to report top-line data in the third quarter of 2015.

APRI closed Monday's trading at $1.69, up 3.05%.

BioBlast Pharma Ltd. (ORPN) has started a phase III pivotal study in the USA and Canada for Cabaletta in Oculopharyngeal Muscular Dystrophy.

This 12 month, placebo-controlled, multi-center phase III study will be initiated in the next quarter, and will begin enrolling approximately 60 patients. The company anticipates the study to be completed by the end of 2016.

ORPN closed Monday's trading 17.01% higher at $6.74.

Cytori Therapeutics (CYTX) has completed enrollment in its U.S. phase IIb trial evaluating ECCO-50 cellular therapeutic in patients with knee osteoarthritis. A total of 94 patients were enrolled as of June 12, 2015.

Based on faster than anticipated enrollment, the company now expects to have six month follow up data for review in Q1 2016.

CYTX closed Monday's trading at $0.66, down 3.10%.

Intra-Cellular Therapies Inc. (ITCI) has completed enrollment in its first phase III clinical trial of its lead product candidate ITI-007 for the treatment of schizophrenia with 450 adult patients.

The company anticipates topline data to be available in the second half of 2015.

ITCI closed Monday's trading at $26.33, down 7.48%.

Lipocine Inc. (LPCN) has successfully completed its labeling "food effect study" for LPCN 1021, its Oral Testosterone product for hypogonadal men with low testosterone.

The labeling "food effect" study is required for submitting the New Drug Application for LPCN 1021.

The topline results from the labeling "food effect" study indicate that bioavailability of testosterone from LPCN 1021 is not affected by changes in meal fat content, noted the company.

The NDA for LPCN 1021 is expected to be filed in the second half of 2015.

LPCN closed Monday's trading at $7.28, up 0.69%.

Genzyme, a Sanofi company (SNY) , has initiated a phase 1/2 clinical trial to evaluate Olipudase Alfa in pediatric patients with nonneurological manifestations of acid sphingomyelinase deficiency, also known as Niemann-Pick disease type B.

Acid sphingomyelinase deficiency is a serious and life-threatening disorder caused by insufficient activity of the enzyme acid sphingomyelinase resulting in toxic accumulation of sphingomyelin. There are currently no approved treatment options for patients with Niemann-Pick disease type B.

The FDA has granted Breakthrough Therapy designation to Olipudase Alfa.

SNY closed Monday's trading at $49.44, down 2.29%.