Transdermal patches will address limitations with existing formulations by:
- Eliminating peak blood levels
- Reducing overall patient exposure to the medicine
- Bypassing first pass metabolism
- Improving patient compliance with a simplified, long-acting dosing regimen
The company is reformulating generic medicines that are well characterized and have a long and robust medical history. As result, ChemioCare will be able to leverage the 505(b)2 regulatory path, enabling:
- lower risk,
- a shortened development timeline,
- and significantly reduced financial investment
Emphasis on focus.
The company is using a lean development approach in a single lead indication to maximize value creation opportunities. There is an exciting opportunity to expand into additional therapeutic areas after accelerating the CINV products to market.
Led by strong Directors and Management with extensive scientific and industry experience.
R&D / Pipeline
Our pipeline of product candidates represents an important opportunity to improve the treatment of patients experiencing CINV. We use proprietary transdermal technology with products that build on the current treatment guidelines.
The company is reformulating generic medicines that are well characterized and have a long and robust medical history. This allows for a shortened development timeline and significantly reduced financial investment and risk by leveraging the 505(b)2 regulatory pathway.
Transdermal technology uses adhesive patches to deliver medicines through the skin. The delivery is a controlled, sustained release over 3-5 days.
Transdermal patches have many key benefits: the first is elimination of peak blood levels. Lower peak blood levels provide the same level of efficacy but avoids or eliminates side effects associated with oral or IV delivery. An additional benefit is that by going through the skin, transdermal patches bypass first pass metabolism. This allows for lower overall exposure to a drug and again, reduced side effects.
ChemioCare is transforming the four active ingredients below using proprietary formulations and advanced transdermal technology. Transdermal delivery is expected to transform the incidence of adverse events by exposing the patient to significantly lower amounts of the active ingredient, avoiding blood peak levels, and avoiding first-pass metabolism.
There is a significant unmet medical need in Highly Emetogenic Delayed CINV (HEC D-CINV); an estimated 65% of patients treated with standard of care achieve complete response (Rapoport 2015). There are no 5-HT3 receptor antagonists approved for the treatment of HEC D-CINV. CMIO-ONDAN is designed to be the first of its class, 5-HT3 receptor antagonists, with an on-label indication for HEC D-CINV.
Ondansetron has a 5.7-hour half life, CMIO-ONDAN has a 5-day sustained transdermal delivery to provide adequate therapeutic blood levels during delayed CINV.
Olanzapine was added to the international guidelines for the treatment of CINV in 2017. It is an atypical antipsychotic that has been found to improve patient outcomes when added to the previous triple-regimen standard of care. Somnolence, constipation, and dry mouth are common side effects associated with current dose forms – affecting between 17.5 and 34% of patients. These are side effects that can be transformed via lower exposure and transdermal delivery.
A genericized steroid recommended by the guidelines for use in both Acute and Delayed CINV Dexamethasone is a first-line standard of care agent, used in nearly every patient. Its use includes control of emesis as well as the control of other effects of Cancer and the Chemotherapy agents - including pain and inflammation. When used at the recommended dose levels, Dexamethasone triggers significant medical side effect challenges for patients including: elevation of blood sugar, a reduction in white blood cells, insomnia, and GI problems.
Dronabinol, delta-9-tetrahydrocannabinol (Δ-9-THC), is a synthetic cannabinoid. Dronabinol is indicated in the guidelines for patients that do not respond to standard of care antiemetics. Oral dronabinol is limited by a lack of efficacy and consistency of efficacy in the treatment of CINV. CMIO-DRONAB is designed to deliver consistent, adequate blood levels of dronabinol, a product with a unique mechanism of action compared to the standard of care.
PEDRO LICHTINGER, CHAIRMAN & CEO
An industry executive with a 37-year career in biotechnology and a proven track record of developing turnaround and financing strategies, executing strategic alliances, and building commercial and R&D capabilities. Former President and CEO of Asterias Biotherapeutics and Optimer Pharmaceuticals with 16 years experience at Pfizer Inc as President of Global Primary Care and President of Europe.
He currently serves on Board of Directors for Gemphire Therapeutics and Sanfer de Mexico and sits on the Advisory Board of Zero Gravity. He holds an MBA degree from Wharton School of Business and an engineering degree from the National University of Mexico.
JAMIE OLIVER, CHIEF MEDICAL OFFICER
Dr. Oliver’s experience spans 12 years in academia and 24 years in both the public and private sectors of the biotechnology/pharmaceutical industry and contract research organizations serving. He has served in numerous roles in clinical development operations including Chief Operating Officer, SVP Clinical Research and Regulatory Affairs, and Chief Science Officer, and Medical Officer. Over his career he has successfully managed large cross-functional project teams with internal staff and oversaw CRO vendors. Dr. Oliver has significant FDA iexperience with both the Drug and Biologic divisions having prepared more than 50 INDs and participated in seven successful NDA submissions for U.S./Global pharmaceutical companies. In his tenure with public and private biotechnology companies, he participated in several series of successful fund raisings. In addition, Dr Oliver has served in licensing negotiations and out-licensing of several oncology assets.
CHRIS CHIPMAN, CHIEF FINANCIAL OFFICER
Mr. Chipman is a managing member of Chipman & Chipman, LLC, providing assistance to public companies with the preparation of periodic reports required to be filed with the SEC and compliance with Section 404 of the Sarbanes Oxley Act of 2002. He was Chief Financial Officer and Secretary of Capital Gold Corporation from 2006 to June 2011. During his tenure, Capital Gold Corporation’s market capitalization increased from $40 million to $420 million. Mr. Chipman successfully negotiated and facilitated the $420 million sale of Capital Gold Corporation to AuRico Gold, Inc. representing a 67% premium over its market price to its shareholders. He has also held senior accounting and financial analyst roles with Grant Thornton LLP and GlaxoSmithKline, and was an Audit Examiner for Wachovia Corporation. He received a B.A. in Economics from Ursinus College and is a Certified Public Accountant. He is a member of the American and Pennsylvania Institute of Certified Public Accountants.
ANDY RENSINK, CHIEF MANUFACTURING OFFICER
Executive bringing over 30 years of operational experience including 13 years experience in transdermal development and manufacturing. Former President and COO of Tapemark, leading development, strategy implementation for pharmaceutical CDMO developing and manufacturing Transdermal Patches and Oral Thin Film products. Currently sits on the Board of Advisors for Hydra-Flex chemical dispensing systems. Holds a Masters in Engineering from Marquette University, BSME from University of Wisconsin and completed the GE Manufacturing Management Program.
CIDNEE VAYKOVICH, DIRECTOR OF OPERATIONS
Known for implementation in the biotech sector, she has spent most of her career creating and validating biotech companies. Previously in New Product Development at Aequus Pharmaceuticals, a transdermal reformulation company. Holds a Master of Management from the University of British Columbia and a Bachelor of Health Science and Biology from Western University
Based in Vancouver, Canada for ChemioCare Inc
MARK ROBBINS, REGULATORY ADVISOR
Biopharmaceutical drug development professional with over 30 years of drug development and commercialization experience in both start-up and fully integrated pharmaceutical/biotechnology companies. Dr. Robbins is President of Kodiak Strategic Consultants. Previously served in senior management positions at Upsher-Smith Laboratories, Certus International, and Mallinckrodt. He has implemented regulatory/clinical strategies leading to many successful NDA/BLA approvals. He received his B.S. degree in Biochemistry from UCLA, his Ph.D. in Pharmacology from the University of Minnesota Medical School, and his J.D. magna cum laude from Saint Louis University.
HEMAL SHAH, HEALTH ECONOMICS & OUTCOMES ADVISOR
Executive bringing over 20 years of experience in health economics & outcomes research (HEOR), real world evidence generation, pricing, market access, value demonstration and health policy. Former Senior Vice President, Medical Affairs, Healthcare Quality, Policy and Outcomes at Optimer Pharmaceuticals and Executive Director of HEOR at Boehringer Ingelheim. She holds a Doctor of Pharmacy from The State University of New Jersey, a BSc. in Pharmacy and a BSc. in Molecular & Cell Biology from University of Connecticut and has completed a post-doctoral fellowship in outcomes research at Geisinger Health System/Novartis.
BOARD OF DIRECTORS
ChemioCare Chief Executive Officer
Chairman of the Board
Managing Director, Corporate Finance, PwC Canada
Chair of Audit Committee
Senior Partner and Portfolio Manager, Fairmont Capital
Managing Director, Transdermal Research Pharm Laboratories
Managing Director, Acquis Consulting Group and Solidea Capital
ChemioCare Director of Operations
Secretary of the Board