Virginia Beach, Virginia-based Predictive Technology Group, Inc., (PRED) has been issued a patent by the United States Patent and Trademark Office covering a progesterone/progestin/cannabis therapeutic and Method of Use for the treatment of endometriosis. PRED subsidiary Predictive Therapeutics, LLC, (PRx) now has exclusive rights to the patent (US Patent 9,149,499).
According to the patent application abstract (US 9149499 B1), the product is a compound comprised of a cannabis portion and at least one portion of progestin and a portion of progesterone. It may optionally also include a non steroidal anti-inflammatory drug (NSAID) component. The compound may be administered in either pill or pellet form (for oral use or for subdermal implantation, respectively), as an injectable solution, or as a suppository, and is intended to treat subjects having or at increased risk of developing — especially genetically determined risk — the common gynecological disorder endometriosis. The compound may also be used for treating other disorders such as chronic pain, and more specifically chronic pelvic pain, or as a contraceptive.
According to the World Endometriosis Research Foundation (WERF) — a global charity that works with 62 institutions in 25 countries advocating and promoting research into endometriosis to improve knowledge and treatments — endometriosis affects an estimated 1 in 10 women during their reproductive years (i.e., usually between the ages of 15 to 49). In people with endometriosis (which is not cancer), endometrium tissue, which normally lines the uterus, begins to grow outside the uterus inducing a chronic inflammatory reaction that may result in scar tissue. The WERF estimates that endometriosis affects an estimated 176 million women worldwide of all ethnic and social backgrounds. Many endometriosis cases remain undiagnosed and are therefore not treated — especially in areas with limited medical resources. For more information, visit: http://endometriosisfoundation.org/Facts-about-endometriosis.pdf
The patent application abstract notes that many therapeutics include progestins — synthetic hormones well-established in treating endometriosis — and further, it has been shown that the concurrent administration of both an NSAID and a progestin can provide an enhanced synergistic effect in treating a disorder as compared to administering an NSAID and/or a progestin separately. Moreover, such concurrent administration may allow for reduced dosages of an NSAID and/or a progestin, as demonstrated in a study published in the American Journal of Obstetrics & Gynecology entitled “NSAIDs and progestins synergistically enhance cell death in ovarian epithelial cells” (AJOG, March 2012, pg 253e1-253e9 DOI: http://dx.doi.org/10.1016/j.ajog.2011.11.012) by G.C. Rodriguez, et al. The study co-authors note that their results suggest it may be possible to combine progestins and NSAIDs to achieve ovarian cancer prevention at lower doses of each component than are required for single administration, thereby lessening the risk of side effects posed by these agents when taken separately in larger doses.
The document also observes that it is further known that cannabis (specifically phytocannabinoids, a class of chemical compounds found in marijuana and certain other herbs that act on cannabinoid receptors in the cells that repress neurotransmitter release in the brain) has been shown to reduce pain and/or reduce sensitivity to pain and may have fewer or none of the side effects typically associated with NSAIDs.
Predictive Therapeutics seeks to advance the treatment of serious and debilitating diseases through the commercialization of novel therapeutics leveraged by proprietary gene-based companion diagnostics. PRx has developed and/or acquired several proprietary technologies that open a window into the origin of human disease, and the role genes and their related proteins play in the disease’s onset and progression. PRx uses this information as the cornerstone in developing new diagnostics that assess a person’s disease risk and therapeutic products designed to effectively prevent and/or treat the disease.
Predictive Technology Group, Inc.
Predictive Therapeutics, LLC
United States Patent and Trademark Office
American Journal of Obstetrics & Gynecology
World Endometriosis Research Foundation
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