This patent, with a priority date of 2008, covers screening mechanisms for identification of small molecules that can modulate the function of a nuclear receptor target that was shown by Dr. Christine Ichim, Regen’s Director of Molecular Therapeutics and University of Toronto Hematologist Dr. Richard Wells to be involved in maintenance of the cancer stem cells.
A Notice of Allowance is issued by the United States Patent & Trademark Office to indicate that it believes an invention qualifies for a patent and that the Office’s examination on the merits has been completed.
This patent will provide the Company with the intellectual property protection it requires in order to develop small molecular drugs that can inhibit the gene target and to develop drugs for the treatment of leukemia and myelodysplastic syndromes.
The patent will also cover screening for small molecules that can turn-on the nuclear receptor. These molecules can be used for expansion of stem cells for expansion of cord-blood in the context of bone marrow transplants.
Currently, it is estimated that 15,000 patients are in need of a stem cell transplant every year. However, 40% of patients cannot be adequately matched with a bone marrow donor. Cord blood stem cell transplants offers hope to these patients since the matching requirement for cord blood is much less stringent than for bone marrow stem cell transplants.
Nevertheless, the number of cord blood transplants performed is constrained by the limited number of cells obtained from a single cord. The ability to expand cord blood cells for bone marrow transplantation may provide life-saving therapy for patients with fatal blood disorders like leukemia, sickle cell anemia, lymphoma, and immune system disorders.
Regen BioPharma chairman David Koos said: "We are very pleased to have received this Notice of Allowance from the U.S. Patent Office granting us patent protection for the proprietary assay system that we are using to develop drugs for modulating stem cell activity by modulating our target nuclear receptor.
"This patent is the result of more than 10 years of research at the University of Toronto, one of the most prestigious Universities in Canada as well as the very place where the blood stem cell was discovered. Currently, the Company’s in-house research endeavors now have a patent protected basis.
"This will strengthen the Company’s intellectual property portfolio moving forward in the small molecule arena. We look forward to rapidly progressing the applications of this technology for clinical use."