BREAKTHROUGH PLATFORM FOR INJECTABLE CONTROLLED-RELEASE CANNABINOIDS TREATMENTS

 

INJECTABLE CBD PATENT APPLICATION FILED OCTOBER 7, 2019

 

Innocan Pharma™ has a worldwide exclusive agreement with Yissum Research and Development Company, the commercial arm of Hebrew University of Jerusalem, to develop a unique platform for injectable CANNABINOIDS loaded liposomes into the bloodstream, or even targeted at a specific organ or body part, with precise time and dosage control.

Liposomes are spherical vesicles composed of one or more layers of lipids that can carry drugs through the human vascular system. Liposomes are one of the most important and most successful delivery systems to date commercialized. There are currently approximately 15 FDA-approved liposomal drugs and many more are known to be in clinical trials. Liposomes are biocompatible and non-toxic and can improve the drug performances: the drug can stay longer in the bloodstream (more availability), the distribution to target organs is improved and the formulation is safer.[1]

The controlled release of CANNABINOIDS from the liposomes allows a continuous exposure of the patient to the drug and decreases the variations of CANNABINOIDS concentration in the blood caused by food intake or other physiological conditions. Moreover a greater portion of intact CANNABINOIDS can reach its target site, decreasing the total amount of CANNABINOIDS needed to achieve the desired therapeutic effect.[2] It is well known that use of CANNABINOIDS in conjunction of steroids, can reduce the amount of steroids and still maintain efficacy.[3] The approach of Professor Yechezkel (Chezy) Barenholz (Hebrew University) is to use this platform to develop a drug (injection) to treat Epilepsy, Rheumatic pain and additional clinical indication to reduce dramatically the steroid amount below the toxic level.

Professor Barenholz is the head researcher and supervisor under the Yissum Agreement. Professor Barenholz serves as the Head of the Laboratory of Membrane and Liposome Research at the Department of Biochemistry of the Hebrew University–Hadassah Medical School, Jerusalem, Israel. Professor Barenholz is the founder of several prominent startup companies, including Moebius Medical Ltd. Professor Barenholz has 46 years of experience in research and development. He is the Executive Editor of Progress in Lipid Research. Professor Barenholz is the author of over 350 publications and is a co-inventor of over 30 patent families, two of which underlie Doxil® for the treatment of breast and ovarian cancer (a doxorubicin remote-loaded sterically-stabilized ~100 nm liposome for treatment of cancer marketed by Johnson and Johnson). Professor Barenholz has been granted various awards for excellent contributions to the field of liposome science. He is a renowned specialist in biochemistry, biophysics, nanotechnology and cancer. He received B.Sc., M.Sc. (cum laude) and Ph.D. degrees, all in Biochemistry, from the Hebrew University of Jerusalem, Israel. In basic research, Professor Barenholz’s laboratory focuses on biochemistry and biophysics of lipids and membranes ― on the relationships between membrane lipid composition, structure (e.g., rafts), and function; on lipid mediated signal transduction; and on apoptosis. One of the main biological topics studied is the relevance of the above to aging processes. In applied research, Professor Barenholz’s main interests are in amphiphile-based drug carriers, especially liposomes: from basic aspects of design of the drug carriers through animal studies and clinical trials, and finally, FDA-approved drugs.

InnoCan’s business strategy for the Yissum Agreement is to sub-licence – per specific indication/drug – to various well-established pharmaceutical companies. The pharmaceutical sub-licensee are expected

The material terms of the Yissum Agreement are to contain terms to pass through to sub-licensees the responsibility for subsequent Yissum payments and for obtaining all required regulatory approvals.

The regulatory pathways of the potential Yissum liposome developed product is anticipated to be one of the following:

  • 505b2 (US) – a regulation allowing relatively short approval process (5-7 years), based on the fact that active pharmaceutical ingredients (API) are well known; or
  • Full FDA-IND path – that might take 7-10 years, including safety studies and Phase 1/2/3 full studies. This path is more expensive than the 505b2 approach;

In any event, the approved approach will be part of negotiations with any sub-licensee of InnoCan.

[1] Barenholz Y. 2012. Doxil®–The first FDA-approved nano-drug: Lessons learned. J Control Release 160:117–34

[2] F. G, Grotenhermen F. 2003. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet 42:327–360

[3] Petrosino S, Verde R, Vaia M, Allarà M, Iuvone T, Di Marzo V. 2018. Anti-inflammatory Properties of Cannabidiol, a Nonpsychotropic Cannabinoid, in Experimental Allergic Contact Dermatitis. J Pharmacol Exp Ther 365:652–663