Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the “Company” or “Kalytera”) today announced that Salzman Group, Inc. has filed a provisional patent application protecting the use of its proprietary, liquid, nitric oxide donor, R-107, for therapy of coronavirus and COVID-19 associated pneumonia. If granted, the patent would offer exclusivity to Salzman Group for the use of this agent in the prevention and treatment of coronavirus-associated and COVID-19 lung infections and acute lung injury until 2041, with potentially extended coverage until 2046 in the USA to compensate for clinical development activity as provided by the Hatch-Waxman Act.
Salzman Group, Inc., a privately held company located in West Tisbury, MA (“Salzman Group”), signed a binding letter of intent on May 12, 2020 to be acquired by Kalytera. Salzman Group is the inventor and owner of R-107, a proprietary small molecule drug with issued and pending composition of matter and method of use patents in approximately 40 countries.
In the United States, R-107 is protected by two issued patents: (1) U.S. patent 9,604,932, which protects the compound per se, as well as its pharmaceutical compositions and methods of use; and (2) U.S. patent 10,000,455, which is a divisional of patent 9,604,932, and which protects methods for treatment of indications that are not specifically covered by patent 9,604,932. Corresponding patents have been granted in Australia, China, Europe, Japan and Russia; and patent applications are pending in Brazil, India and South Korea
The newly filed provisional patent application strengthens this patent portfolio by providing for specific method of use protection for the prophylaxis and treatment of acute lung injury induced by coronaviruses, including SARS-1 and COVID-19. Upon conversion of the provisional patent filing to a PCT application, Salzman Group will have the right to apply at the national phase for patent protection in any country where it believes there is an unmet medical need to combat coronavirus or COVID-19 infection.
There are currently no drugs or other therapeutics approved by the U.S. FDA to prevent or treat COVID-19, and there are no existing pharmaceuticals registered for the prevention or treatment of pneumonitis secondary to COVID-19 virus infection. Current clinical management includes only infection prevention, and supportive care, including supplemental oxygen and mechanical ventilator support when indicated.
Following a submission of an Investigational New Drug Application (“IND”), scheduled for Q2 2020, the Company intends to carry out a Phase 1a safety and pharmacokinetic study of R-107 in healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.
The Salzman Group is a privately held GMP and GCP compliant pharmaceutical development firm located in West Tisbury, MA. Based on over two decades of drug development experience and a strong track record, Salzman Group continues to generate groundbreaking pharmaceutical opportunities.
Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel medicines for a range of important unmet medical needs.
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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, success of any funding initiatives, 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, licensing and acquisition transactions, and/or any private placement or public offering may not proceed as expected or may produce unfavorable results, or that any financing may not proceed as planned, and the risk of the contemplated transactions not proceeding or closing on the terms initially contemplated. 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.