Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the
"
Company" or "
Kalytera") today
provided an update on its lead clinical development program
evaluating cannabidiol (“
CBD”) for the prevention
and treatment of acute graft versus host disease
(“
GVHD”).
GVHD 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, GI tract, liver, lungs, and eyes. GVHD is associated with
acute and chronic illness, infections, disability, reduced quality
of life, and death.
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. There are currently no FDA
approved therapies for either the prevention or treatment of acute
GVHD.
The commercial opportunity for Kalytera’s CBD products for the
prevention and treatment of GVHD is large. According to the January
2018 Market Forecast Report by DelveInsight Perspective, projected
annual sales for prevention and treatment of GVHD in the 7 major
markets (the U.S., Germany, France, Italy, Spain, the U.K.
and Japan) are estimated to be more than USD $408 million in 2018,
and could grow to approximately USD $1.3 billion by 2027.
Kalytera is the exclusive licensee of two issued U.S. patents
covering the use of CBD in the prevention and treatment of GVHD,
and is also the exclusive licensee of pending patent applications
in other jurisdictions for the use of CBD in the prevention and
treatment of GVHD.
The U.S. FDA has recommended that Kalytera apply for both
Breakthrough Therapy and Fast Track Designations for our CBD
products for prevention and treatment of acute GVHD, each of which
could accelerate the approval process for these products.
CBD is a non-psychotropic ingredient of cannabis
sativa that possesses potent immunomodulatory and anti-inflammatory
properties.
Kalytera’s Program Evaluating CBD in
Prevention of Acute GVHD
Our ongoing Phase 2b clinical study evaluating the use of CBD in
the prevention of GVHD is expected to be completed early next year.
We have enrolled patients at clinical sites in Israel, and, in
order to expedite the enrollment process, we are in the process of
expanding this study to include two additional sites in Australia.
Upon completion of this Phase 2b clinical study, we will begin
preparations for the pivotal Phase 3 clinical study that will be
required for FDA approval.
The ongoing Phase 2b clinical study is a 36-patient
randomized, multicenter study, which will evaluate the safety,
pharmacokinetics, pharmacodynamics, efficacy and dose ranging of
CBD for the prevention of GVHD following bone marrow
transplantation procedures. 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.
Prior to our ongoing Phase 2b clinical study, we completed two
Phase 2a clinical studies evaluating CBD in the prevention of GVHD.
Data from both of these Phase 2a clinical studies were positive and
highly encouraging. Dr. Moshe Yeshurun, Kalytera’s Chief Medical
Officer, was the Principal Investigator for both of these studies,
which were conducted at the Institute of Hematology, Davidoff
Center, Rabin Medical Center, Petah Tikva, Israel.
The results from the first of these Phase 2a clinical studies
were published in Biology of Blood and Marrow Transplantation
(Cannabidiol for the Prevention of Graft-versus-Host-Disease after
Allogeneic Hematopoietic Cell Transplantation: Results of a Phase
II Study, M. Yeshurun et al. / Biol Blood Marrow Transplant 21
(2015) 1770 - 1775). The data from this study, in which 48 patients
received daily doses of 150 mg of CBD administered twice daily for
7 days prior to the bone marrow transplant procedure and for 30
days after, demonstrated the following results:
- 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 who received
standard GVHD prophylaxis at the same institution in Israel (the
Institute of Hematology, Davidoff Center, Rabin Medical Center);
and
- CBD was found to be safe and well tolerated
In the second of the two prior Phase 2a clinical
studies, 12 patients were administered CBD at a dose of 150 mg
administered twice daily from 7 days prior to the bone marrow
transplant procedure until up to 100-days post transplantation. In
that study, no safety issues were observed, and 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
from patients treated at the same institution in Israel (the
Institute of Hematology, Davidoff Center, Rabin Medical Center)
that were used as a control.
“Acute GVHD is a severe complication of bone marrow
transplant procedures that can lead to permanent impairment of
quality of life and even death,” said Robert Farrell, President and
CEO of Kalytera. “With no FDA approved therapy for the prevention
of acute GVHD, there exists an important unmet medical need that we
believe we can address. Based on the positive and encouraging
results from the two prior Phase 2a clinical studies that we
completed in prevention of GVHD, we are optimistic that our CBD
product will address this unmet need, and will be demonstrated to
be a safe and effective means to prevent the onset of acute
GVHD.”
Kalytera’s Program Evaluating CBD in the Treatment of
Acute GVHD
We are planning to initiate a seamless Phase 2-3 pivotal
registration study in the treatment of acute GVHD later this year.
There are currently few options to treat patients with acute GVHD,
a critically underserved market.
Our Phase 2-3 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 25 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.
Kalytera previously completed a Phase 2a clinical study in the
treatment of acute GVHD entitled, Cannabidiol for the Treatment of
Severe (Grades 3-4) Acute Graft versus-Host Disease. Dr. Moshe
Yeshurun, Kalytera’s Chief Medical Officer, was the Principal
Investigator for this study, which was conducted at the Institute
of Hematology, Davidoff Center, Rabin Medical Center, Petah Tikva,
Israel.
All ten patients in the Phase 2a clinical study were steroid
refractory, meaning that they had not responded to previously
administered standard of care steroid treatment. The study design
was an open label, single arm, addition to standard of care
treatment. Ten subjects, 18 years of age or older, participated in
the study. The patients were administered a fixed oral dose of a
highly pure formulation of CBD that was extracted from cannabis and
dissolved in olive oil. The fixed dose of 150 mg of CBD was
administered twice daily for up to three months, alongside standard
of care therapy.
The results of this Phase 2a study were positive and highly
encouraging. Nine of the ten patients responded to treatment, with
seven achieving complete remissions, and with two achieving
near-complete responses. Six patients are still alive with a median
follow-up period of 13 months (range 5-30 months). These results
compare favorably with the results of the historical control group
of 29 patients with steroid-refractory grades 3-4 GVHD who were
treated at the same institution in Israel (the Institute of
Hematology, Davidoff Center, Rabin Medical Center), among which 26
patients died from GVHD and its complications.
“The ability to treat GVHD is a major unmet need,” stated Robert
Farrell, Kalytera’s President and CEO. “With no FDA approved
therapy, acute GVHD remains a major cause of morbidity and
mortality following bone marrow transplantation procedures. Based
on the very positive data from our Phase 2a clinical study, we
believe that our CBD product may provide a major advance in the
treatment of acute GVHD.”
About Kalytera TherapeuticsKalytera
Therapeutics, Inc. 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.
- Website Home: https://kalytera.co/
- News and Insights: https://kalytera.co/news/
- Investors: https://kalytera.co/investors/
Cautionary StatementsNeither 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.
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.
Contact Information
- Robert Farrell President, CEO (888) 861-2008
info@kalytera.co
- Colwell Capital Corp.Graeme
Dick1-403-561-8989graeme@colwellcapital.com
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