Continued advancement for expansion into nutraceutical market Results from animal studies evaluating bioavailability of impregnated CoQ10 with beta glucan expected Q4 2017 Encouraging preliminary data from bio-efficacy study evaluating avenanthramides in exercise-induced inflammation warrant extension to evaluate additional biomarkers

 

EDMONTON, ALBERTA--(Aug. 18, 2017) -Ceapro Inc. (TSX VENTURE:CZO) ("Ceapro" or the "Company") a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today its financial results for the three-month and six-month periods ended June 30, 2017 and provided an overview of recent operational highlights.

 

Financial Highlights for the Second Quarter 2017

Total sales of $3,173,000 for the quarter ended June 30, 2017 compared to $4,168,000 in Q2 2016;

The Study’s 928 patients are being monitored and continue to be followed for protocol-specific outcomes

 

VIENNA, Va. -- CEL-SCI Corporation (NYSE American: CVM) today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company’s Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume.

 

Multikine is being studied as a potential first-line (before any other cancer treatment is given) immunotherapy that is aimed at harnessing the patient’s own immune system to produce an anti-tumor response. Nine hundred twenty-eight (928) newly diagnosed head and neck cancer patients have been enrolled in this Phase 3 cancer study and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol.

Macrilen™ NDA filed at end of Q2; FDA granted a PDUFA date of December 30, 2017 --- All amounts are in US Dollars

 

Recent key developments

Macrilen™ development progressing toward completion

The Company announced on June 30, 2017 that a new drug application (“NDA”) seeking approval of Macrilen™ (macimorelin), an orphan drug, for the evaluation of growth hormone deficiency in adults (“AGHD”) was resubmitted to the U.S. Food and Drug Administration (the “FDA”) on such day.

On July 18, 2017, the Company announced that we had been notified by the FDA that our NDA seeking approval of Macrilen™ for the evaluation of AGHD had been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.

- FDA Grants Clearance for Use in Human Food and Animal Feed --

 

DAVIS, Calif. & ROSARIO, Argentina --  Arcadia Biosciences, Inc. (Nasdaq: RKDA) and Bioceres S.A. announced today their joint venture, Verdeca, received notification that the U.S. Food and Drug Administration (FDA) has completed its full review of the company’s safety evaluation for HB4 soybeans. The FDA’s notice to Verdeca allows products derived from HB4 soybeans to be used commercially in human food and animal feed. This is a major milestone in the development of commercial soybean seed products based on the HB4 stress tolerance trait.