Gotta break somedayInfo may be a repost, but I needed a remnder as to why I'm here:
Pipeline Development Oat Beta Glucan: -- Resumed enrollment of patients for the clinical trial with beta glucan as a cholesterol reducing natural pharmaceutical product. The study will enroll approximately 264 patients. To date, two thirds of the patients have been screened and randomized. -- Received approval from Health Canada for an amendment to the protocol to allow evaluation of subjects with confirmed pathophysiological condition of hyperlipidemia who voluntarily request to be treated with beta glucan only, without regular dosing of statins. This significant change, allowing patients to receive beta glucan as a stand-alone therapy, has accelerated patient enrollment and is expected to expand the target addressable patient population.
Avenanthramides: -- Announced the publication of positive results from study evaluating avenanthramides in exercise-induced inflammation in the international, peer-reviewed Journal of the International Society of Sports Nutrition. Positive results support anti-inflammatory claims for avenanthramides as a nutraceutical product and pave the way for a Phase 1 clinical trial as a potential pharmaceutical product. -- Continued to monitor stability studies for liquid avenanthramides produced at a new manufacturing site as well as for the pharmaceutical-grade dry powder formulation of avenanthramides to be used in a human Phase 1 bioavailability and safety study.
New Products: Cannabis -- Received approval from Health Canada Controlled Substances and Cannabis Branch for a five-year research license with medical cannabis for the formulation of unique solid cannabinoid delivery systems using PGX technology.
Yeast Beta Glucan (YBG) -- Developed an optimal formulation of YBG coming from various sources. -- Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation. -- Achieved the first milestones in successful development of PGX-processed yeast beta glucan product as a potential inhalable therapeutic for COVID-19 and other fibrotic endpoint diseases of the lung. -- Conducted an in-vitro study with human cell lines demonstrating that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response through activation of beta glucan specific Dectin 1 receptors. -- Ongoing PGX-YBG project with McMaster University conducted in parallel for nave and preclinical animal models. To date, no safety issues have been encountered. The preclinical phase has been extended to identify the maximum tolerated dose. -- Conducted additional in vitro PGX-YBG dose response study to correlate with upcoming McMaster animal study results. YBG induces immunomodulation without affecting inflammation pathways. This product is poised to become a key strategic asset for the Company.
New Chemical Complexes: -- Developed new PGX-dried chemical complexes like sodium alginate and gum arabic impregnated with co-enzyme Q10 (CoQ10). Positive results published in peer-reviewed journals demonstrate the versatility of the PGX Technology and the potential to develop significant bioactive delivery systems. Key learnings from these studies pave the way for the scale-up of the technology at the commercial level. -- Subsequent to year-end, Ceapro announced the successful completion of a long-term research program conducted with University of Alberta. This screening program allowed Ceapro to retain the most promising products and expand the PGX-based products pipeline.
Technology: -- Performed significant technical upgrades of PGX pilot plant in Edmonton to allow production of yeast beta glucan for a potential clinical trial with COVID-19 patients. -- Completed a feasibility study for the commercial scale up of the PGX Technology. Several manufacturers and existing supercritical plants were contacted in 2020 for the choice of equipment and location. Given excellent results obtained with the new yeast beta glucan product, it became clear that location of the first large scale PGX unit should be close to the best source of raw material which was found in Germany where the Company also acquired pieces of equipment suitable for the assembling of such unit. Production at the retained site will be mostly for the commercialization of yeast beta glucan as an immune booster and for alginate as a carrier for other bioactives. -- Initiated installment in Edmonton of a commercial scale unit for impregnation of bioactives with PGX-processed biopolymers. -- Pursued research collaboration projects with University of Alberta and McMaster University for the impregnation of various bioactives using PGX-processed biopolymers as potential delivery systems for multiple applications in healthcare.
Bioprocessing Operations -- Completed the integration of production operations under one roof in Edmonton. Ceapro's dedicated production team successfully responded to the growing market demand for the cosmeceutical base business by producing over 250 metric tons of active ingredients in 2020, a 25% increase over the previous year. -- Received renewal of the Site License from the Health Canada Natural Product Directorate. This License enables the Company to manufacture, package, label, release and distribute final products.
Corporate -- Fully repaid loan with Agriculture Financial Services Corporation. -- Announced expansion of a grant from National Research Council of Canada for the optimization and mass production of yeast beta glucan as a potential inhalable therapeutic for COVID-19 and other fibrotic end-point disease of the lung. -- Pursued out-licensing discussions for PGX-processed new chemical complexes. -- Secured DTC Eligibility for publicly traded shares under Ticker OTCQZ: CRPOF and to expand Company exposure to other markets with an emphasis in USA.