ChemioCare Announces Appointment of Roy F. Waldron to Its Board of Directors

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company focused on proprietary transdermal delivery, announced today the appointment of Roy F. Waldron to its Board of Directors, effective immediately.

Mr. Waldron brings over 20 years of legal and intellectual property experience to ChemioCare. He recently retired from his role as Senior Vice President‚ Associate General Counsel and Chief Intellectual Property Counsel at Pfizer. There, he led global teams of Pfizer attorneys and professionals in procuring patents‚ and worked closely with R&D‚ Business Development and Pfizer Business Units to develop and strengthen intellectual property strategies for development and acquisition targets. He holds a JD from New York University Law School‚ a PhD from Yale and a BA from Dartmouth College.

“We are pleased to welcome Roy to our Board of Directors. His experience in developing, executing, and defending Intellectual property strategies at Pfizer will be invaluable as we continue to build our company" said Pedro Lichtinger, Chairman and CEO, “We expect to continue to strengthen the IP portfolio for our PETT platform and for each unique patch as they progress in their development process and generate novel data and findings”

Roy added, “As a firm believer that innovation is absolutely fundamental to delivering better healthcare to patients, I am thrilled to be part of a team prioritizing inventive technologies to solve longstanding drug delivery challenges."

About ChemioCare

A biotechnology company focused on improving the profiles of medicines through its proprietary permeation enhanced transdermal technology (PETT). 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 programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is aiming at establishing improved efficacy, a new indication, 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 Announces Initiation of PETT Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program

ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company focused on proprietary transdermal delivery, announced today the Company is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes that by applying its permeation enhanced transdermal technology (PETT), it can potentially target and deliver the optimal continuous lenalidomide AUC (drug level area under the curve) that may lead to reduced drug toxicity and improvement in the overall safety profile of the drug. These improvements can be expected to allow patients to stay on their treatment longer with fewer dose interruptions while improving their quality of life. The benefits of transdermal delivery may transform lenalidomide PETT into a new superior drug profile.

Lenalidomide is the standard of care for the treatment of multiple myeloma, and is also indicated for the treatment of certain forms of myelodysplastic syndrome and mantle cell lymphoma. In 2018, revenues reached $9.6 billion globally with $6.5 billion in the US. The branded form is projected to continue to grow at double digit growth rates in the coming years. Lenalidomide represents a major well-established blockbuster product with no clear replacement in development in the world of Oncology. Lenalidomide is expected to experience first generic entries in 2021 or 2022.

ChemioCare conducted a systematic assessment of feasibility and market potential to identify PETT transdermal reformulation targets from the thousands of potential opportunities that exist. These opportunities were further refined to select key patches which fit in the technology and may have the potential to benefit patients the most. “ We are delighted to launch the first program out of the PETT prioritization project, which has the potential to transform the multiple myeloma treatment paradigm” said Pedro Lichtinger, Chairman and CEO.

The characteristics of our novel PETT platform provide a broad horizon to improve the delivery of many drugs to achieve superiority or enable new indications. Drugs delivered by PETT can be developed to target optimal blood levels for prolonged periods of time thereby minimizing the high and low blood levels associated with toxicities or treatment failure. “PETT technology works like a continuous injection of drug into the blood stream that can be precisely delivered to provide the right amount of drug to work without providing too much drug which can cause toxicity” said Dr. Jamie Oliver, CMO. Dr Oliver further stated that “in the case of lenalidomide, both efficacy and toxicity are associated with its AUC and oral medications just are not able to precisely maintain the optimal blood levels over the dosing interval.”

About ChemioCare

A biotechnology company focused on improving the profiles of medicines through its proprietary permeation enhanced transdermal technology (PETT). 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 programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is aiming at establishing improved efficacy, a new indication, 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 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.