Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera“) today announced the formation of a Strategic & Scientific Advisory Board with three key appointments: Professor Joseph Lynch, Ph.D.; Dr. Li Zhang; and Professor Hanns Ulrich Zeilhofer.
The Strategic and Scientific Advisory Board will work closely with Kalytera’s management to advance the Company’s novel cannabinoid-based technology for the treatment of acute and chronic pain, identify new applications for Kalytera’s cannabinoid technology, and provide insight regarding new cannabinoid-based technologies to complement the Company’s pipeline.
“We are thrilled to have attracted some of the world’s leading experts in pain to our Strategic and Scientific Advisory Board,” said Robert Farrell, Kalytera’s President and Chief Executive Officer. “The formation of our SSAB further validates the scientific and clinical merit for our pain product and our pipeline of CBD based pharmaceuticals.”
Professor Joseph Lynch, Ph.D.
Dr. Lynch completed a BSc majoring in Physics at the University of Melbourne. He then moved to the University of New South Wales to undertake a Masters of Biomedical Engineering, and then a Ph.D. in Physiology. His postdoctoral studies were undertaken in Germany, France and at the Garvan Institute of Medical Research in Sydney. He moved to University of Queensland in 1996 as a Senior Lecturer in the School of Biomedical Sciences, and was awarded an NHMRC Senior Research Fellowship in 2004 (renewed in 2009). He relocated to the Queensland Brain Institute in October 2007.
Dr. Li Zhang
Dr. Zhang has worked as an NIH Staff Scientist in the Laboratory for Integrative
Neuroscience since 2004. He is an expert in neuropharmacology, and has published in Nature Chemistry and Biology, including a paper entitled “Cannabinoid potentiation of glycine receptors contributes to cannabis-induced analgesia.” Kalytera’s novel, proprietary cannabinoid-naproxen conjugate is based in part on Dr. Zhang’s pioneering research demonstrating that cannabinoids suppress inflammatory and neuropathic pain by targeting alpha3 glycine receptors.
Professor Hanns Ulrich Zeilhofer
Dr. Zeilhofer studied medicine at the University of Erlangen in Germany. He did his postdoctoral training at the University of Erlangen, the Max Planck Institute for Biophysical Chemistry and at ETH Zürich. From 2001 to 2005 he was associate professor of Molecular Neuropharmacology at the Institute of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen. In September 2005 he joined the Institute of Pharmacology and Toxicology, University of Zurich, and, in addition, in January 2016, the Swiss Federal Institute of Technology (ETH) Zurich, as a full professor of pharmacology. He currently serves as the director of the Institute of Pharmacology and Toxicology of the University of Zurich and as a member of the research council of the Swiss National Science Foundation. He is also a founding member of the Drug Discovery Network Zurich (DDNZ). His research has been supported by grants from the European Research Council (ERC), the Swiss National Science Foundation and the Wellcome Trust, among others. His research has led to the identification of alpha3 glycine receptors as promising targets in chronic pain conditions. Dr. Zeilhofer has received scientific prizes from the SANDOZ-Foundation for Therapeutic Research, the German Association for the Study of Pain, the Sertürner Society and the PHOENIX Pharmacy award.
“The background and experience of these three experts will be invaluable as we move through IND-enabling studies toward initial clinical testing” stated Farrell. “A major focus of their research has been the molecular structure and function of the alpha3 glycine receptor that mediates inhibitory neurotransmission in the brain. Kalytera’s cannabinoid-naproxen conjugate is intended to target the alpha3 glycine pain receptor, which has recently emerged as a promising therapeutic target for pain. Drs. Lynch, Zhang and Zeilhofer are leaders in this field of research, and I am very proud to have them join us as founding members of our Strategic & Scientific Advisory Board established in connection with this novel cannabinoid-based technology for the treatment of pain.”
About Kalytera’s Product in Development for Treatment of Pain
Kalytera’s compound in development for treatment of pain consists of a cannabinoid conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is already approved for treatment of pain. This cannabinoid/naproxen conjugate has potential to become a next generation pain medication, and, based on the potentially complementary methods of action of the cannabinoid and naproxen, there is reason to believe these molecules may have a synergistic effect in treatment of pain, as well as a superior safety profile compared with opioid analgesics.
The objective of Kalytera’s program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated. The cannabinoid component will act as a cannabinoid receptor agonist, targeting the alpha3 glycine pain receptor in the spinal cord, and the naproxen component will block the synthesis of the pain-inducing molecule PGE2. Although the initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation.
The commercial opportunity for Kalytera’s cannabinoid/naproxen conjugate is large. According to a 2016 report by Transparency Market Research, the global pain management therapeutics market is projected to reach $83 billion by 2024. Current treatments for pain mainly include non-steroidal anti-inflammatory drugs (“NSAIDs”), such as naproxen, for mild to moderate pain, and opioids, such as morphine, for moderate to severe and chronic pain. Kalytera believes that its product will be suitable for mild to severe pain, without the risks of respiratory suppression and dependence associated with opioid analgesics.
Kalytera’s strategy will be to advance this compound through Phase 1 and Phase 2 clinical testing, and then seek to out-license or sell the program to a multinational pharmaceutical company. If successful, the commercial opportunity for this program could be very significant.
Kalytera Therapeutics, Inc. (“Kalytera“) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on graft versus host disease (“GVHD”).
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This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.