Patient Dosing Phase Complete in First Human Clinical Trial for ANANDA's Liquid Structure™ CBD Formulation
GREENWOOD VILLAGE, Colo. & JERUSALEM, February 25, 2020 (Newswire.com) - ANANDA Scientific Inc., together with HADASSAH Medical Hospital, today announced the successful completion of subjects’ dosing in the first human clinical trial being conducted at Hadassah Medical Center to assess ANANDA’s unique and innovative Nano-Sized Self-assembled Liquid Structure™ CBD formulation. The conclusion of this phase marks another major milestone in the effort to pioneer meaningful evidence-based treatments using groundbreaking delivery technology for cannabinoids.
“We are thrilled to have successfully completed this initial human clinical trial and to have achieved another major milestone in progressing our patented know-how for efficiently moving cannabinoids into the bloodstream," said Mark J. Rosenfeld, M.S., Ph.D., Chief Executive Officer and Chief Science Officer. “Completing this cutting-edge clinical work to FDA standards is an impressive feat in and of itself and an important first step in support of eventual U.S. drug approval.”
This trailblazing clinical trial assessed the bioavailability and safety of ANANDA’s Liquid Structure™ CBD formulation, technology licensed from Lyotropic Delivery Systems (LDS) Ltd. and The Hebrew University of Jerusalem in Israel. It was conducted under the approval of the hospital’s Institutional Review Board and of the Israel Ministry of Health. Biochemical analysis is now underway with statistical review to immediately follow. The final report is expected in May.
“Successful completion of this critical phase of the clinical trial significantly advances the applications of this groundbreaking delivery technology,” said Professor Yoseph Caraco from The Hadassah Medical Center, who is the Lead Investigator for the trial. “We are extremely pleased to be working with ANANDA and know our work has further advanced making cannabinoids effective medicine."
Upon successful completion of this study, ANANDA intends to move as quickly as possible into next-stage human clinical trials to assess the efficacy of ANANDA’s CBD Liquid Structure™ Technology for treating chronic pain, initially in patients with diabetic neuropathy and later for other indications as well.
ABOUT HADASSAH MEDICAL HOSPITAL CLINICAL RESEARCH CENTER
Hadassah Clinical Research Center (HCRC) is part of the Clinical Pharmacology Unit which is affiliated with the Division of Medicine at the Hadassah-Hebrew University Medical Center. The HCRC was established in 2008 and is the leading early-phase facility in Israel. Studies conducted at the HCRC cover a wide range of medical disciplines including, but not limited to, cardiovascular, endocrinology, neurology, infectious disease, gastroenterology, and rheumatology. Approximately 50% of the studies conducted at the HCRC are sponsored by international pharmaceutical companies. The HCRC staff consists of two physicians, six study coordinators, and a dedicated pharmacist. The director of the HCRC is Professor Yoseph Caraco, leading clinical pharmacologists with both national and international reputation. The HCRC facility consists of 15 beds equipped with ICCU monitoring capabilities and enables confinement of study participants if required by the study protocol.
ABOUT ANANDA SCIENTIFIC
ANANDA is a research-focused biotech company that employs patented delivery technologies to make cannabinoids and other plant-derived compounds highly bioavailable, water-soluble and shelf-life stable nutraceutical and pharmaceutical products. ANANDA is pursuing clinical trials for pharmaceutical approval that use its technology to address therapeutic targets of tremendous public health importance. On the back of its strong research base, the company has a growing pipeline of nutraceutical over-the-counter products. The company has successfully launched these in the U.S., U.K., and EU, with expansion into China, Australia and Africa planned for the near future. The company is expanding its research base through multiple sponsored research agreements with universities to diversify its technology footprint.
Contact for ANANDA Scientific:
ANANDA Scientific Media Relations
Contact for Hadassah Medical Hospital:
Hadassah Medical Center Spokesperson
Source: ANANDA Scientific Inc.