Cellceutix Corporation (CTIX)
Kevetrin™ - Our Patented Lead Compound
Link to US Patent Number 8338454
Other Kevetrin Patent Applications
NITRILE DERIVATIVES AND THEIR PHARMACEUTICAL USE AND COMPOSITIONS July 26,2012
NITRILE DERIVATIVES AND THEIR PHARMACEUTICAL USE AND COMPOSITIONS September 13,2013
The Phase 1 trial for solid tumors is at Harvard Cancer Center's Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
The trial, titled, "A Phase I, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (thioureidobutyronitrile) Administered Intravenously in Patients with Advanced Solid Tumors," will be conducted for the determination of the pharmacokinetics, pharmacodynamics, tolerance, safety, and maximum tolerated dose in patients with the diagnosis of refractory solid tumors. Approximately 40 patients will be enrolled in the dose escalation portion of study. In addition, once the MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level to further evaluate this dosage safety and pharmacodynamics.
The Principal Investigator for the trial is Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center and Associate Professor of Medicine, Harvard Medical School.
The primary objectives are:
- To determine the maximum tolerated dose (MTD) of Kevetrin.
- To determine the dose limiting toxicities (DLT) of Kevetrin.
- To establish a safe dose level of Kevetrin that can be used for future studies.
The secondary objectives are to determine the following:
- The pharmacokinetics of Kevetrin in humans.
- Observe for evidence of antitumor activity following administration of Kevetrin.
- If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical/cellular effect.
- If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.
Cellceutix has participated in a meeting with the U.S. Food and Drug Administration (“FDA”) pertaining to our psoriasis compound, Prurisol™. Cellceutix had requested the meeting for guidance on its initiatives to seek a section 505(b)(2) designation for Prurisol™, which would allow the Company to forgo early-stage trials and advance Prurisol™ into later-stage clinical trials.
The FDA informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™.
Cellceutix has begun the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance.
Cellceutix has announced that it has signed an agreement with a European Union (EU) clinical site for a Proof-of-Concept (PoC) trial of Prurisol™, the Company’s lead drug candidate for the treatment of psoriasis. The trial, a double blind study, is planned for the latter part of 2013 and will include patient dosing over a 30-day period with follow up visits over the next 30 days. They are hoping the results will pave the way for a large, multi-center Phase III clinical trial for Prurisol in 2014.
The trial is expected to begin in August 2013.
KM-133 is a small molecule, acting on the principles of immune stimulation and PRINS reduction, that has been found to be effective against psoriasis in animal models, both in induced psoriasis as well as a xenograft model with human psoriatic tissue. It is easily synthesized and has the potential for oral dosing. KM 133 significantly reduced all psoriatic endpoints measured relative to controls.
The Company reported on 11/12/12 that it has signed an agreement with a European Union (EU) clinical site for a Proof-of-Concept (PoC) trial of Prurisol™, the Company's lead drug candidate for the treatment of psoriasis.
KM-391, a 100% novel compound, is revolutionary in that it addresses the core issues of autism, unlike the pharmaceuticals presently on the market which merely treat the symptoms that result from autism. Preliminary testing of KM-391 revealed that test animals showed a significant increase in serotonin uptake compared to controls with noticeable and measurable positive therapeutic changes. Cellceutix is rapidly developing KM-391 in response to the public outcries received by the company since the results of early testing had been made publicly available.
The Company has procured leading figures in the health and science arenas to lead its development efforts. The officers and advisors of Cellceutix include pioneers in the fields of cancer and genetics, as well as those who have been integral to mergers, acquisitions and the generation of exorbitant revenues through ground breaking therapies while holding high-level executive and research positions at industry giants such as Pfizer and Eli Lilly. Holding over a century of highly relevant experience in the pharmaceuticals industry, the team has been assembled with the specific goal of duplicating these past successes while revolutionizing much needed treatments for today's most challenging diseases.
***Kevetrin, a compound that activates p53 "Guardian Angel of the Human Genome" in pre-clinical trials. ALL THINGS P53--http://oregonstate.edu/instruction/bb492/lectures/p53Lecture.html (thank-you Seel)
Clinical trials .gov http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
Cellceutix has brought together leading figures in the health and science arenas to work toward the goal of developing innovative small molecule therapies for areas of unmet medical need, particularly cancer and inflammatory disease. The officers and advisors of Cellceutix include pioneers in the fields of cancer and genetics, as well as people with wide experience in the pharmaceutical business and their invaluable experiences cover all areas of researching, developing, and marketing ground breaking therapies. Chief Executive Officer, Chairman of the Board of Directors- Leo Ehrlich, CPA:
Served as Chief Financial Officer (CFO) of Cellceutix Pharma since inception in June 2007. Following the acquisition, he was appointed CFO and a director. From October 8, 1999 to the present time, Mr. Ehrlich has been a director at StatSure Diagnostic Systems, Inc. and has held different executive officer positions at that company including CEO, President, and his current title of CFO. Mr. Ehrlich was also CFO and a director of Nanoviricides, Inc. from June 1, 2005. until May 2007. Mr. Ehrlich is a Certified Public Accountant and received his BBA from Bernard Baruch College of the City University of New York.
President, Chief Scientific Officer, Board of Directors - Dr. Krishna Menon: RCM, PhD, VMD - Dr. Krishna Menon has more than 25 years in drug development for academia and industry. Originally trained as a veterinary surgeon, Menon began his career as the Senior Government Veterinarian for a major Parish in Jamaica. He segued to a two-year stint as Director of Agriculture for the Cayman Islands, in the British Caribbean and, in 1983, moved to the Dana Farber Cancer Research Institute, where he worked under the direction of Dr. Emil Frei. Two years later, he earned his PhD in Pharmacology from Kerala University in 1988. Menon's PhD work focused on anti-folate therapy of various cancers. Menon was a Research Associate Scientist at Dana Farber (Harvard University) from 1988 to 1991 and Research Scientist, In Vivo Research (Cancer & Metabolic Diseases), at Miles Laboratories from 1991 to 1993. After a year operating his own veterinary oncology and drug development consultancy practice, Menon was tapped Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly (1995-2001), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta which in 2006 had over 2.1 billion dollars ($2,100,000,000) in sales, and is a co-developer of another seven compounds currently in late-stage clinical development. In 1999, Lilly honored Menon with the President's Recognition Award.
Emil Frei III, MD: Dr. Frei was one of the world's leading oncologists, a pioneer of chemotherapy and a leader in medical research, clinical practice and education. His distinguished career included 40 years in top leadership positions such as Chief of Medicine at National Cancer Institute, Associate Scientific Director at M. D. Anderson, and Director and Physician-in-Chief at the Dana-Farber Cancer Institute. He continued as Physician-in-Chief, Emeritus, at Dana-Farber until his passing in 2013. He will be greatly missed as both a friend and a Scientific Advisory Board member of Cellceutix.
Dr. Paul Marks, MD: As President and Chief Executive Officer, Dr. Marks led Memorial Sloan-Kettering Cancer Center for 19 years, beginning in 1980. He remains a vital part of MSKCC as President Emeritus and Member of the Sloan-Kettering Institute. Dr. Marks's research in cell biology and cancer genetics has made major contributions toward a new approach to cancer treatment and prevention, through the development of new and more potent chemotherapy and chemoprevention agents. He also helped establish the highest standards for research and patient care at MSKCC and has provided leadership in the national and international medical science community.
Dr. Samuel Danishefsky, Scientific Advisor: Dr. Samuel Danishefsky is an internationally recognized leader in chemistry, specializing in the synthesis of biologically active organic compounds. He is regarded as one of the world's leading chemists in cancer research. Dr. Danishefsky earned his Ph.D. in chemistry from Harvard. He spent 14 years at Yale University, where he rose to the rank of Sterling Professor of Chemistry, the highest academic rank at Yale University, awarded to a tenured faculty member considered one of the best in his or her field. By 1991, he was also sharing his time with Memorial Sloan-Kettering Cancer Center as director of the Laboratory for Cancer Research Bioorganic Chemistry, becoming chair in 1993. He accepted an appointment as professor at Columbia University in 1993, and now conducts research at both institutions. Further information is available at www.mskcc.org/mskcc/html/64932.cfm
Dr. Paul Ginsburg, Scientific Advisor: Dr. Paul Ginsburg received his Ph.D. in Chemistry from the City University of New York and his law degree from Columbia University where he was a Harlan Fiske Stone Scholar. He was elected to Phi Beta Kappa at the City College of New York and to the scientific research honor society Sigma Xi at CUNY.
Dr. Ginsburg has spent most of his career in law firms and as corporate counsel representing large and small pharmaceutical, biotechnology, chemical and consumer products companies. He recently retired from Pfizer Inc., where he served as Head of the New York Patent Department and worked on patent matters relating to several blockbuster products, including Viagra and Chantix, and represented Pfizer on the intellectual property committees of the National Association of Manufacturers, the Chemical Manufacturers Association and the Biotechnology Industry Organization. Dr. Ginsburg has lectured widely on pharmaceutical and biotechnology patent prosecution and licensing at the Practicing Law Institute and Columbia Law School and before other groups. Prior to his twenty -year career at Pfizer, Dr. Ginsburg was a senior attorney at Schering-Plough. He was subsequently recruited by Merck and then by the highly respected IP firm Fish & Neave.
Dr. Ginsburg is perhaps most well-known as the author of the patent covering Schering- Plough's hugely successful product Claritin. He also authored important patents covering Schering-Plough's highly successful alpha-interferon product.
Dr. Ginsburg has authored the patent application covered the Cellceutix anticancer product Kevetrin which has been filed in the United States and other countries and has advised Cellceutix on patent and licensing matters during the past few years.
Jim Boeheim, Business Advisor: Coach Boeheim has earned icon status in the world of basketball. Coaching on the sidelines of the Carrier Dome court that is now named after him, Boeheim has an 900-304 (.747) overall record; ranking him second in wins among active Division I coaches and third all-time in college basketball. Syracuse has nine Big East regular season championships, five Big East Tournament championships and 28 trips into the NCAA Tournament, including four Final Four appearances with a NCAA championship in 2003. Boeheim has earned bronze and gold medals for his role as assistant coach in the 1990 FIBA World Championship, the 2006 FIBA World Championship, the 2008 Summer Olympics, the 2010 FIBA World Championships in Turkey, and the 2012 Summer Olympics. In September 2005, Boeheim was inducted into the Basketball Hall of Fame.
Boeheim's list of basketball accolades are only paralleled by his philanthropic efforts in the field of cancer. Surviving his own battle with prostate cancer, Boeheim now heads the Jim and Juli Boeheim Foundation and has become a major advocate for Coaches vs. Cancer, the Children's Miracle Network, the Make-A-Wish Foundation, Easter Seals, the Special Olympics and more. His dedication to Coaches vs. Cancer, a non-profit collaboration between the National Association of Basketball Coaches and the American Cancer Society, has helped raise $4.5 million for the American Cancer Society's Central New York chapter over the past 12 years.
Common Stock as of September 17, 2013 was 101,518,984 outstanding Fully diluted = ~149M
Authorized Shares: 300M
Insiders Own: 70.5%
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