Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the “Company” or “Kalytera”) announced today that it is working with Salzman Group toward completing definitive agreements for Kalytera’s acquisition of Salzman Group (the “Acquisition”). On May 19, 2020, Kalytera announced that it had signed a binding Letter of Intent dated May 12, 2020 to acquire Salzman Group, Inc., a privately held company located in West Tisbury, MA (“Salzman Group”).
Salzman Group is the owner of R-107, a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea. Salzman Group is developing R-107 for treatment of COVID-19 associated lung disease, chlorine inhalation lung injury (“CILI”) and pulmonary arterial hypertension (“PAH”).
Kalytera is not making any express or implied claims that R-107 has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.
Kalytera and Salzman Group had expected that definitive agreements for the Acquisition would be executed by June 15, 2020. Although the definitive agreements have not yet been executed, both Kalytera and Salzman Group are working to complete the definitive agreements, and anticipate that these agreements will be executed shortly.
In anticipation of the close of the Acquisition, the companies have already begun working together to accelerate development of R-107.
“Given the data demonstrating the antiviral activity of nitric oxide against coronaviruses1, as well as the even greater body of data demonstrating the potential activity of nitric oxide in treatment of viral-associated lung disease2, Kalytera and Salzman Group have already begun working together to advance R-107 into Phase 1 clinical testing,” stated Robert Farrell, President and CEO of Kalytera. “We plan to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Authority (FDA) later this month in support of a first-in-human Phase 1 clinical trial. We are planning to carry out this Phase 1 safety and pharmacokinetic study of intramuscular R-107 using a single dose escalation design in 32 healthy middle-aged volunteers at CMAX, a clinical contract research organization located at Royal Adelaide Hospital in Australia. The study will be initiated during the third quarter, and we expect it to be completed during fourth quarter this year.”
- Akerstrom S et. Al. Nitric oxide inhibits the Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005; 79(3):1966-9.
- Nitric Oxide Investigated as COVID-19 Treatment
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.
Kalytera Therapeutics, Inc. (“Kalytera”) is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing and delivering innovative human therapeutics. Kalytera focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people’s lives.
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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. 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.