ChemioCare Reports Positive Animal Study Results for CMIO-Ondan Patch

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company based on proprietary transdermal delivery, today announced the minipig safety and pharmacokinetic study results of CMIO-Ondan, a 5-day transdermal formulation of ondansetron for the treatment of chemotherapy induced nausea and vomiting (CINV). In summary, the animal study demonstrated that CMIO-Ondan can deliver sustained blood levels of ondansetron above that equivalent to the minimum effective dose in humans over five days. The preclinical safety and irritation results demonstrate that the formulation appears to be non-irritating.

This primary objective of the current study was to measure ondansetron plasma concentrations following the application of a single transdermal patch over the clinical dosing interval in minipigs. The current data shows that it is possible to prepare an adhesive matrix patch of commercially feasible size capable of delivering therapeutic quantities of ondansetron through the skin.

The patch site was visually inspected before and after patch application and removal and assessed for skin irritation using the Draize skin irritation scale. The average total score was 0.6 on the first day and was virtually zero after 2 days. This indicates only very mild transient irritation. Additionally, the maximum blood concentration or Cmax observed was well below the level that is established to trigger QT prolongation.

Pedro Lichtinger, Chairman and CEO added, "The safety and pharmacokinetic data support continued development of ChemioCare’s ondansetron matrix patch. We are proceeding to finalize and manufacture an improved formulation which we intend to advance into GLP/GMP studies."

CMIO-Ondan is scheduled to enter a Human Proof of Concept (POC) clinical study later this year. The main objectives of the POC clinical study will be to assess the optimal dose, safety, tolerability and pharmacokinetic profile of CMIO-Ondan in healthy human subjects.

"The results of this preclinical study demonstrate that CMIO-Ondan can provide sufficient blood levels to achieve efficacy in the delayed stage of CINV," said Jamie Oliver, Chief Medical Officer. "No currently available 5-HT3 receptor antagonist has been successful in providing additional protection to patients from vomiting for a full 5 days following Highly Emetogenic Chemotherapy. CMIO-Ondan is designed to provide protection from nausea and vomiting in both acute and delayed stage CINV symptoms by providing a quick onset as well as sustained efficacy – avoiding the periods of unprotection due to ondansetron’s short 4-hour half-life."

Highlights of the Results and Next Steps

  • CMIO-Ondan successfully delivers sustained plasma concentrations of ondansetron in vivo through a minipig animal model

  • Using standard skin sensitization and irritation scales, no major skin irritation issues were observed

  • The patch sized used is within commercially feasible limits

  • GLP/GMP manufacture will now proceed to provide clinical supplies for further studies including a GLP skin sensitization study

  • A clinical proof of concept (POC) study will be conducted in healthy subjects using a dose-escalation design. The study is expected to be conducted in mid-2019.

  • Following human proof of concept, CMIO-Ondan is anticipated to enter directly into a pivotal Phase 3 clinical trial. Regulatory feedback towards the design of this trial will be provided at a pre-IND meeting with FDA to be requested in March with an FDA response by the end of May 2019.

About ChemioCare

A biotech company focused on improving the profiles of generic medicines through its proprietary transdermal delivery technology. The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care, its lead two programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is establishing improved efficacy and reduced or eliminated side effects from originator products.

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.

ChemioCare Strengthens Executive Management Team

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a Platform Company based on proprietary transdermal delivery today announced the appointment of Jamie Oliver, Pharm.D PhD. to the Company as Chief Medical Officer and Chris Chipman, CPA, as its Chief Financial Officer.

“Our company has made substantial progress. We now have multiple proprietary transdermal patches in development focusing on new indications of generic medicines that will address significant unmet medical needs. It is time to strengthen our management team and I am pleased to have been able to attract Jamie and Chris to our rapidly growing company,” said Pedro Lichtinger, ChemioCare Chairman and CEO.

Dr. Oliver is a distinguished clinical development executive with more than 24 years experience in both the public and private sectors of the biotechnology/pharmaceutical industry and contract research organizations. He will leverage his strategic, scientific, and industry experience to guide product development including the launch of two Phase 3 clinical studies late 2019.

Prior to joining ChemioCare, Dr. Oliver was the Chief Scientific Officer at Accelovance, Inc. an oncology contract research organization. He has also served as Chief Executive Officer at Phage Pharmaceuticals, Inc. and prior to that was a Principal at Trinity Drug Partners, LLC. Dr. Oliver has amassed significant clinical research experience in both preclinical and clinical experimentation in academia and the pharmaceutical industry. Dr Oliver has strong therapeutic experience in the areas of oncology, hematology, vaccines, infectious diseases, immunopharmacology, renal disease, and transplantation. Dr. Oliver has significant FDA experience 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.

Chris Chipman has more than 24 years experience as an accountant primarily working with publicly traded companies across industries. He successfully negotiated and facilitated the $420 million sale of Capital Gold Corporation to AuRico Gold representing a 67% premium over its market price to its shareholders. He will lead the preparation of ChemioCare’s S-1 filing to become a publicly traded company in 2019.

Mr. Chipman has been a managing member of Chipman & Chipman, LLC, since November 2000, a consulting firm that assists public companies with the preparation of periodic reports required to be filed with the Securities and Exchange Commission and compliance with Section 404 of the Sarbanes Oxley Act. Mr. Chipman was Chief Financial Officer and Secretary of Capital Gold Corporation from 2006 to June 2011. Capital Gold Corporation was a publicly-held gold production and exploration company, until its acquisition by AuRico Gold, Inc. (formerly, Gammon Gold). During his tenure, Capital Gold Corporation’s market capitalization increased from $40 million to $420 million. He has provided accounting services for a variety of clients including pharmaceutical, agriculture and construction industries.

About ChemioCare

A biotech company focused on improving the profiles of generic medicines through its proprietary transdermal delivery technology. The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care, its lead two programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is establishing improved efficacy and reduced or eliminated side effects from originator products.

 

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made.  The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.

ChemioCare Initiates Development Program in Pediatric CINV

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company focused on proprietary transdermal delivery today announced that its Adult Ondansetron 5-day adhesive transdermal patch will initiate development and be adapted for use in pediatric Chemotherapy Induced Nausea and Vomiting (CINV).

It is recognized that when treated with chemotherapy, children (ages 5+) are more prone to vomiting than adults. CINV presents in two phases: Acute (day 1) and Delayed (days 2-5). Pediatric CINV does not have any approved or guideline-recommended treatments for the delayed phase of CINV in Highly Emetogenic Chemotherapy (HEC). Current guidelines recommend three IV infusions of a 5HT-3 receptor antagonist every four hours following chemotherapy; this treatment regimen provides protection in the Acute phase only.

“A pediatric CINV transdermal patch will address a significant unmet medical need and improve the quality of life and outcomes for children and teenagers that have to go through chemotherapy. With approximately nineteen thousand children and young adults ages 0-19 diagnosed each year, the indication will be classified as a pediatric orphan. The pediatric development program can be expected to employ the time, cost, and data protection benefits provided to orphan disease development programs” said Chairman and CEO, Pedro Lichtinger. He added, “From our initial payer and provider research, we expect broad endorsement for CMIO-ONDAN in Pediatrics and increased formulary adoption in the adult population.”

A pediatric transdermal patch leverages the breakthrough development by ChemioCare for their Ondansetron 5-day transdermal patch under development for adult CINV. These potential benefits include offering fast CINV protection when applied up to one hour prior to Chemotherapy as well as sustained protection for five days.

The pediatric transdermal patch will be the first and only protection for the Highly Emetogenic Chemotherapy (HEC) delayed stage, improving the quality of life and outcomes in children. The patch will also provide cost savings by substituting multiple IV applications, reduced infusion chair time, avoidance of stomach tubing, and avoidance of noncompliance and expulsion of medicine.

About ChemioCare

A biotech company focused on improving the profiles of generic medicines through its proprietary transdermal delivery technology. The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care, its lead two programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is establishing improved efficacy and reduced or eliminated side effects from originator products.

To learn more, visit www.chemio.care

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.

ChemioCare Expands Proprietary Transdermal Platform

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a biotech company focused on transforming patient outcomes in cancer supportive care, today announces a successful Drug Enforcement Administration (DEA) registration: ChemioCare’s exclusive formulation development partner, Transdermal Research Pharm Laboratories LLC (TRPL), has obtained a new registration with the DEA as a Manufacturer authorized to handle Schedule 1 controlled substances.

This successful DEA registration allows TRPL to initiate formulation development of a dronabinol transdermal patch, CMIO-DRONAB, the fourth program in parallel development in the ChemioCare supportive care platform. Pedro Lichtinger, ChemioCare Chairman and CEO explains, “Advancing our dronabinol program is another development milestone for our Company. We have made significant progress establishing unique profiles for each patch, all are driven by on-label superiority. The profiles have expanded beyond our initial focus on CINV, establishing ChemioCare as a platform supportive care company.” The DEA registration also establishes an opportunity to research additional indications for dronabinol by leveraging its activity at cannabinoid receptors.

The Company has identified significant unmet medical needs that its Olanzapine and Dexamethasone patches, CMIO-OLANZ and CMIO-DEX, are uniquely positioned to address:

  • CMIO-OLANZ, olanzapine 7-day transdermal delivery system (TDS), is the first product in development for PARP inhibitor induced nausea and vomiting. CMIO-OLANZ formulation development is expected to complete its Proof Of Concept in animals before the end of the year.

  • CMIO-DEX, dexamethasone 7-day TDS, dexamethasone is used extensively in the control of swelling and edema in Brain Cancer and Brain Surgery. Dexamethasone is highly effective in this setting but unfortunately causes severe side effects. We believe that the use of transdermal technology can maintain efficacy while significantly reducing side effects by bypassing the first metabolism pass and CMax characteristics of the current oral use. Our Laboratory has shown flux and is working on improving steady state delivery.

CMIO-ONDAN, ondansetron 5-day transdermal patch, has completed a POC study in animals and is also expected to complete its human POC study mid 2019. CMIO-ONDAN is in development to be the first 5HT3 Receptor Antagonist to obtain an indication for delayed CINV in the Highly Emetogenic Chemotherapy (HEC) patient segment. This product’s Phase 3 clinical program has been validated by our Scientific Advisory Board and is in the process of being included in our request for a pre-IND meeting with the FDA.

By leveraging its Transdermal Platform and the 505(b)2 regulatory path, both CMIO-ONDAN and CMIO-OLANZ are expected to be ready to enter their phase 3 clinical programs next year.

About ChemioCare

A biotech company focused on transforming patient outcomes in cancer supportive care. ChemioCare has a platform of transdermal patches in development using proprietary, proven technology. The company is targeting the 505(b)2 regulatory path and establishing on-label superiority that addresses a major unmet medical need for patients, establishing improved efficacy and reduced or eliminated side effects from reference products.

To learn more, visit www.chemio.care

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the company's control, involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the company. Neither the company, nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, business, financial condition, liquidity and results of operations may vary materially for from those expressed in the aforementioned forward-looking statements.