ANTH Awaits Lupus Study Data, FDA Nod For IPXL, TNXP To Report Trial Data In Q4

(RTTNews) - Anthera Pharmaceuticals Inc. (ANTH) has reached the enrollment target of 400 patients in its phase III clinical trial evaluating Blisibimod for the treatment of lupus.

In the trial, dubbed CHABLIS-SC1, which is being conducted in 15 countries across Asia, Eastern Europe and Latin America, patients receive either 200mg of Blisibimod or placebo in addition to their standard-of-care medication for 52 weeks. Final data from the trial is expected in the second half of 2016.

ANTH touched a new high of $9.56 on Tuesday before closing the day's trading 7.99% higher at $9.33.

Akers Biosciences Inc. (AKER) said that the response to its Wellness products, known as BreathScan OxiCheck and BreathScan KetoChek, which were introduced in May, has been overwhelmingly positive.

The company noted that BreathScan OxiCheck and BreathScan KetoChek, together with the bluetooth-enabled reading device, BreathScan Lync, which synchs via an app on any mobile device, will enable consumers to monitor trends in critical metabolic processes. In addition, suppliers of nutritional supplements and diet plans, and health coaches in fitness centers, will be able to more effectively monitor and adjust the progress of their clients.

AKER closed Tuesday's trading at $4.60, up 0.66%.

BriaCell Therapeutics Corp (BCT.V) has entered into a Definitive Agreement to begin current Good Manufacturing Processes compliant manufacturing of BriaVax.

BriaVax is the company's proprietary cancer immunotherapy being tested in the upcoming phase I/II clinical trial that will enroll up to 24 patients with advanced stages of cancer. It is anticipated that manufacture of fully qualified, clinical-grade BriaVax should be completed during the third quarter of this year.

BCT.V closed Tuesday's trading at C$0.25, unchanged from the previous day's close.

The FDA has approved Impax Laboratories Inc.'s (IPXL) ZOMIG Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.

ZOMIG Nasal Spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients. It was first approved by the FDA in September 2003 for the acute treatment of migraine attacks, with or without aura, in adults.

IPXL closed Tuesday's trading at $47.60, up 1.26%.

Ocular Therapeutix Inc. (OCUL) has begun enrollment in a phase III clinical trial to evaluate the safety and efficacy of DEXTENZA for the treatment of allergic conjunctivitis.

DEXTENZA is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.

This is the first of two phase III studies, and the primary endpoints to be evaluated are ocular itching and conjunctival redness at day 7. The secondary efficacy measures for both itching and redness are measured at day 14 following insertion and on days 27-30 post-insertion, added the company.

OCUL closed Tuesday's trading at $23.09, up 2.35%.

RedHill Biopharma Ltd.'s (RDHL) Clinical Trial Application to initiate a second phase III study of RHB-104 for Crohn's disease in Europe has been accepted by the regulatory agency.

The trial, dubbed MAP EU study, is planned to commence in a selected number of European counties, and, once initiated, will run in parallel with the currently ongoing US first phase III trial, known as the MAP US study.

The MAP EU Phase III study is expected to enroll 360 patients with moderately active Crohn's disease. Patients will be randomized 2:1 to receive either RHB-104 or a placebo for 52 weeks, and then evaluated for remission at week 26 as the primary endpoint.

The ongoing MAP US phase III study is expected to enroll 270 patients with moderately to severely active Crohn's disease, with interim analysis expected in the second half of 2016.

RDHL closed Tuesday's trading at $19.79, up 3.78%.

Tonix Pharmaceuticals Holding Corp. (TNXP) has begun randomizing patients into a phase II clinical study of TNX-201 in episodic tension-type headache. The study is expected to enroll approximately 200 patients at nine clinical centers in the United States.

The company plans to report top-line results from the study in the fourth quarter of 2015.

TNXP closed Tuesday's trading at $9.90, up 6.91%.

XOMA Corp.'s (XOMA) drug candidate XOMA 358 has been granted Orphan Drug Designation by the FDA for the treatment of congenital hyperinsulinism.

The company recently completed a positive phase I study, results of which suggest XOMA 358 is active against the insulin receptor and shows potential in treating patients who experience an endogenous over-production of insulin.

The company expects to initiate a phase II study of XOMA 358 in the indication of congenital hyperinsulinism later this year.

XOMA closed Tuesday's trading at $3.66, down 0.54%.