- Announces Meeting with FDA to Obtain Consent for Start of Phase 3 Pivotal Registration Study in Treatment of Acute GVHD
- Provides Corporate Update and Outlook for 2018
Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the “Company” or “Kalytera“) today issued the following letter to shareholders from the Company’s President and CEO, Robert Farrell.
Dear Kalytera Shareholders,
I would like to provide an update, describe our business strategy, and express my gratitude for your support of the work Kalytera is doing.
Our Business – CBD and Proprietary CBD Analogues
Kalytera is developing cannabidiol (“CBD”) pharmaceuticals. We are also developing pharmaceuticals made with our proprietary CBD analogues, which are patent pending variations of CBD and CBD conjugates.
Kalytera and a small number of other companies are developing CBD for the treatment of various diseases and disorders, and, importantly, we expect that one of these other companies may receive the first ever approval of a CBD pharmaceutical product later this year. This approval could provide validation of CBD’s safety and effectiveness, and we would view this as a very positive development for Kalytera.
We are a Leader in the Field – We Expect Our Phase 3 Study to Start Later this Year
Our program evaluating CBD in the prevention of graft versus host disease (“GVHD”) is in late-stage clinical testing, and we have scheduled a meeting with the FDA’s Division of Hematology Projects to obtain consent to initiate a Phase 3 pivotal registration study in treatment of acute GVHD later this year.
The Commercial Opportunity in GVHD is Large
GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life and death.
The commercial opportunity for Kalytera’s CBD products in the treatment and prevention of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, projected annual sales in the 7 major markets (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) is estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027.
We Have Strong Intellectual Property
We recently announced that the U.S. Patent and Trademark Office (“USPTO”) has issued our patent covering the use of CBD in the treatment of GVHD. We anticipate that our patent covering the use of CBD in prevention of GVHD will be issued next month.
In addition to our patents and patent applications covering the use of CBD in GVHD, we have also obtained four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe.
Our Near-Term Phase 3 Program in Treatment of GVHD
We are planning to initiate a Phase 3 pivotal registration study in the treatment of acute GVHD later this year.
There are currently few options to treat persons with GVHD, a critically underserved market. The data from our previous clinical study evaluating CBD in the treatment of acute GVHD were exceptional and unprecedented. Ten patients with acute (grades 3-4) GVHD who were refractory to standard treatment with high-dose steroids were administered daily doses of CBD for up to three months. Nine of the ten patients responded to treatment, with seven achieving complete remissions, and with two achieving near-complete responses. Based on these very positive data, we believe that our CBD product may provide a major advance in the treatment of this disease.
The Phase 3 pivotal registration study will enroll approximately 135 patients and will assess the safety and efficacy of multiple doses of CBD for the treatment of acute GVHD. The study will be a multicenter, multinational, placebo controlled, randomized clinical trial, for the evaluation of the safety and efficacy of CBD for the treatment of Grade 3-4 acute GVHD. The study will be conducted in up to 20 sites in Australia, Israel, The United Kingdom and the U.S. The Principal Investigator of the study is Edmund Waller, M.D., PhD., Professor, Hematology and Medical Oncology, Medicine, and Pathology at Emory University School of Medicine, and Director, Division of Stem Cell Transplantation and Immunotherapy at Winship Cancer Institute of Emory University.
Our Ongoing Phase 2 Program in Prevention of GVHD
Our ongoing Phase 2 clinical program evaluating the use of CBD in the prevention of GVHD is expected to be completed later this year. Upon completion of this Phase 2 work, we will begin preparations for the pivotal Phase 3 study that will be required for FDA approval.
It is estimated that up to 50% of patients who undergo a bone marrow transplant from a fully matched sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD.
Data from our previous clinical studies evaluating CBD in the prevention of acute GVHD were positive and highly encouraging. In a published study of 48 patients who received daily doses of CBD for 7 days prior to the bone marrow transplant procedure and for 30 days after, the results were as follows:
- No patients developed acute GVHD while being treated with CBD
- The rates of grades 2-4 acute GVHD by day 100 were 12.1%, compared with 46% in 101 historical control subjects given standard GVHD prophylaxis
- CBD was found to be safe and well tolerated
The results of a separate 12 patient study demonstrated that only 15% of patients in the CBD treatment group developed grades 2-4 acute GVHD, compared to a 60-70% incidence predicted by historical data used as a control.
Our ongoing Phase 2 study in prevention of GVHD is designed to assess the safety profile of multiple doses of CBD for the prevention of GVHD. The study will enroll 36 patients at three clinical sites in Israel and one clinical site in Australia. The Principal Investigator of the study is Daniel Couriel, M.D., M.S., Director of the Bone Marrow Transplant Program at the University of Utah Health Sciences, School of Medicine.
Our Program in the Treatment of Acute and Chronic Pain
In addition to our programs in treatment and prevention of GVHD, we have also recently announced the initiation of our program to develop a novel, proprietary CBD analogue for the treatment of acute and chronic pain.
Our compound consists of a CBD analogue 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 promise of this novel compound is that the two active agents, the CBD analogue and naproxen, may provide effective pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have also found a way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care. Our 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.
Our Value Enhancing Business Strategy
We are a pharmaceutical product development company, focusing on the development of CBD pharmaceuticals, and pharmaceuticals made with our proprietary CBD analogues.
We will grow our company’s value as we advance our products through the regulatory approval process. We are currently at the Phase 2 stage with our ongoing clinical study in the prevention of GVHD, and we expect to advance to Phase 3 with the initiation of our pivotal registration study evaluating CBD in the treatment of GVHD. We anticipate that this could be a significant value-driving event.
In addition to our programs in treatment and prevention of GVHD, we have also recently announced the initiation of our program to develop a novel, proprietary CBD analogue for the treatment of acute and chronic pain. The initiation of this program was an important first step in our overall strategy to expand and diversify our product development portfolio.
Our Goals for the Next Year
We are well positioned to become a global leader in the development and commercialization of CBD pharmaceuticals.
We believe that CBD, and our proprietary CBD analogues, have the potential to be among the most important pharmaceutical compounds in the years to come.
We are currently in late-stage clinical testing with our ongoing Phase 2 study in the prevention of GVHD. This study will be completed later this year, and we will begin our Phase 3 study in prevention of GVHD during 1H 2019.
We will begin our Phase 3 pivotal registration study in the treatment of acute GVHD later this year.
As we advance our GVHD program into the final phases of clinical testing, we will begin seeking regional partnering opportunities outside of North America to provide non-dilutive sources of funding and monetize this program through licensing, milestone and royalty revenue.
We are excited about 2018 and beyond, and we believe that Kalytera has blockbuster potential.
Thank you for your ongoing support.
Robert Farrell, President and CEO
Kalytera Therapeutics, Inc. (“Kalytera“) is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.
President and CEO
Phone: (888) 861-2008
Colwell Capital Corp.
Phone: (403) 561-8989
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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.