PRESS RELEASES
09
Sep
2019
Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development

PRESS RELEASE
 

Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development
 

  • Novoheart seeks to revolutionize human heart tissue engineering for disease modeling and drug discovery
  • Peer-reviewed publications feature results from the completion of two research contracts between Novoheart and Pfizer
  • Novoheart’s proprietary MyHeartTM Platform of human bioengineered heart tissues can represent healthy as well as diseased heart conditions


VANCOUVER, BC – SEPTEMBER 9, 2019 – Lab-grown heart tissues and chambers from Novoheart, (“Novoheart” or the “Company”) (TSXV: NVH; FWB: 3NH), a global stem cell biotechnology company, demonstrate advanced capabilities for drug screening as well as disease modeling which can lead to safer drugs with better efficacy, according to new research.

Novoheart’s bio-artificial human heart tissues and chambers are used by global pharmaceutical companies for accurate preclinical testing of the effectiveness and safety of new drugs, with a mission of maximizing the successes in drug discovery while minimizing costs and harm caused to patients. Results from two research contracts with Pfizer’s Global Safety Pharmacology Unit and Rare Disease Research Unit show that using cells from either healthy individuals or patients with a rare inherited disease, Novoheart’s proprietary MyHeartTM Platform can achieve key outcomes needed to improve the drug discovery and development pipeline.

The first study with Pfizer’s Global Safety Pharmacology Unit was published in Clinical Pharmacology & Therapeutics1, a peer-reviewed journal of the American Society for Clinical Pharmacology & Therapeutics. The strong predictive capabilities of Novoheart’s human ventricular cardiac tissue strips (hvCTS) and cardiac organoid chambers (hvCOC, aka “human heart-in-a-jar”) from the MyHeartTM Platform were proven through a blinded study using cardiac cells derived from healthy donors. The Platform correctly classified about 90% of the drugs provided by Pfizer, before their identities were revealed to Novoheart investigators.

The healthy “human heart-in-a-jar” further confirmed the results and revealed more adult-like heart characteristics and a greater sensitivity to positive inotrope drugs that stimulate cardiac contractility. The findings led to a two-tiered screening strategy that can provide an improved drug discovery approach to better predict clinical outcomes.

In the second study, published in the July 2019 issue of Stem Cell Research and Therapy2, Novoheart developed the world’s first customized, 3D engineered, human cardiac tissue models of Friedreich’s ataxia (FRDA), a rare neuromuscular degenerative disease that affects over 1 in 50,000 people worldwide. FRDA patients have a defective Frataxin gene, which often leads to lethal heart complications. This new disease model, based on MyHeartTM assays, was created using genetically modified as well as FRDA patient-derived cells, capturing both electrical and mechanical defects of the heart observed in FRDA patients.

This new approach marks an important step away from using animals as traditional testing models – they have limited predictive ability for drug discovery due to dramatic differences from human physiology. Novoheart’s FRDA models, on the other hand, offer an innovative and powerful human-based platform to develop new therapies for FRDA’s cardiac symptoms, for which no effective treatments are currently available.

With sole ownership of the intellectual property rights, Novoheart is now commercializing the FRDA disease model and has subsequently confirmed commercial contracts with multiple drug developers.

“Heart disease is a leading cause of death for both men and women, accounting for over 30% of all deaths worldwide. These peer-reviewed publications from our ongoing collaborations with Pfizer showcase the robustness of our bioengineered heart constructs as next-generation, human-specific drug screening and disease modeling tools,” said Novoheart’s Chief Scientific Officer, Dr. Kevin Costa. “We take great pride in the accuracy, sensitivity and throughput of our technology, and continue to strive for further advancements through constant innovation. Based on these exciting results, we can expand our versatile MyHeartTM Platform by developing additional models of human heart disease, desperately needed for the development of safer and more effective therapies for patients worldwide.”

1 Clin Pharmacol Ther. 2019 Aug;106(2):402-414. doi: 10.1002/cpt.1385.
2
Stem Cell Res Ther. 2019 Jul 8;10(1):203. doi: 10.1186/s13287-019-1305-y.

 

About Novoheart

Novoheart is a global stem cell biotechnology company that pioneers an array of next-generation human heart tissue prototypes. It is the first company in the world to have engineered miniature living human heart pumps that can revolutionize drug discovery, helping to save time and money for developing new therapeutics. Also known as 'human heart-in-a-jar', Novoheart’s bio-artificial human heart constructs are created using state-of-the-art and proprietary stem cell and bioengineering approaches and are utilized by drug developers for accurate preclinical testing of the effectiveness and safety of new drugs, maximizing the successes in drug discovery while minimizing costs and harm caused to patients. With the recent acquisition of Xellera Therapeutics Limited for manufacturing Good Manufacturing Product (GMP)-grade clinical materials, Novoheart is now developing gene- and cell-based therapies as well as next-generation therapeutics for cardiac repair or regeneration.

 

Media Contacts

Media Relations
media@novoheart.com


Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

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Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the risks identified in under the heading “Risk Factors” in Novoheart’s annual information form for the year ended June 30, 2018 or other reports and filings with the TSX Venture Exchange and applicable Canadian securities regulators. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements.

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