FDA Lifts Advaxis Clinical Hold

PRINCETON, N.J., Dec. 16, 2015 -- Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2. Advaxis will therefore resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

“We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

Acasti Provides Update on CaPre® Development Pathway

• Seeking formal approval to commence bioavailability bridging study

LAVAL, Quebec, Dec. 16, 2015 -- Acasti Pharma Inc. (“Acasti” or the “Corporation”) (ACST) (APO.V), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that it has received positive feedback from the US Food and Drug Administration (FDA) on the proposed development pathway for CaPre®.

“Recently, we received encouraging comments from the FDA based on our briefing package submission indicating that the 505(b)(2) pathway represents a course for regulatory review and approval, and that Acasti’s plans for the bioavailability bridging study are viewed as sound,” highlighted Pierre Lemieux, PhD, Acasti’s Chief Operating Officer.  “With this endorsement, Acasti will submit an amendment to its current Investigational New Drug (IND) application to commence a bridging study, while continuing to work closely with the FDA to ensure the Corporation is aligned with their views on CaPre® clinical development.”

Aequus Announces Completion of Dosing in Phase 1 Clinical Trial of Aripiprazole Transdermal Patch

VANCOUVER, BRITISH COLUMBIA--(Dec. 14, 2015) - Aequus Pharmaceuticals Inc. (TSX VENTURE:AQS) (AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced completion of dosing in the first stage of its Phase I clinical trial for the once-weekly transdermal aripiprazole patch, AQS1301.

This study is the first in a two-stage Phase I proof-of-concept program designed to assess the rate of absorption and to evaluate the profile of drug delivery over a 7-day period with Aequus' transdermal formulation in twelve healthy volunteers. Previous in vitro and animal studies indicated that aripiprazole, in a proprietary formulation, could adequately be absorbed through the skin. The current clinical study is the first time a topical or transdermal formulation has been applied to humans.