Kalytera
Therapeutics, Inc. (TSX VENTURE:
KALY and OTCQB: KALTF) (the "
Company" or
"
Kalytera") today announced positive data from its
ongoing Phase 2 clinical study evaluating cannabidiol
(“
CBD”) for the prevention of acute graft versus
host disease (“
GVHD”) following bone marrow
transplant.
The clinical study criteria that are used to determine the
efficacy of CBD in prevention of acute GVHD are:
- Disease free survival at Day 100 after bone marrow
transplant;
- Disease free survival at Day 180 after bone marrow
transplant;
- Cumulative incidence of grade 2-4 acute GVHD at Day 100 after
bone marrow transplant; and
- Cumulative incidence of grade 2-4 acute GVHD at Day 180 after
bone marrow transplant.
To date, 3 of the 12 patients in the first cohort have died from
causes unrelated to GVHD. The data for the remaining 9 patients
demonstrate encouraging preliminary evidence of efficacy as
measured by each of the above listed outcome endpoints:
- Disease free survival at Day 100: Eight of the
9 surviving patients are disease free (no evidence of grades 2-4
acute GVHD) at Day 100;
- Disease free survival at Day 180: Three
patients are now more than 180 days post bone marrow transplant,
and each of these patients is disease free;
- Cumulative incidence of grade 2-4 acute GVHD at Day
100: The cumulative incidence of grades 2-4 acute GVHD at
Day 100 is encouraging, with only one patient having developed
grade 2 acute GVHD, the least serious form of the disease, prior to
Day 100; and
- Cumulative incidence of grade 2-4 acute GVHD at Day
180: The cumulative incidence of grades 2-4 acute GVHD at
Day 180 is encouraging, with only one patient having developed
grade 2 acute GVHD, and with none of the surviving patients who are
now more than 180 days post bone marrow transplant having developed
grades 2-4 acute GVHD.
In summary, no patients in the first cohort of
the Phase 2 clinical study have developed grades 3 or 4 acute GVHD
while receiving oral CBD treatment, and only one patient developed
grade 2 acute GVHD.
“We are very encouraged by these excellent results,” stated
Robert Farrell, President and CEO of Kalytera. “The first cohort in
our Phase 2 study is the low dose cohort, with patients receiving
only 75 mg of CBD twice daily (“BID”). We did not
anticipate that the results for the low dose cohort would be as
positive as they are. We are now enrolling the second 12-patient
cohort. The patients in the second cohort will receive 150 mg of
CBD BID.”
The results of the first cohort are in line with data from the
two earlier Phase 2a clinical studies that were completed by Dr.
Moshe Yeshurun, Kalytera’s Chief Medical Officer, at the Institute
of Hematology, Davidoff Center, Rabin Medical Center, Petah Tikva,
Israel. The results from the first of these 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. / Biology Blood Marrow Transplant 21
(2015) 1770 - 1775).
Bone marrow transplantation procedures are among
the greatest success stories in cancer treatment. The vast majority
of patients receiving bone marrow transplants are patients with
various forms of blood cancers, such as leukemia, lymphoma or
multiple myeloma, and bone marrow transplantation has boosted
survival rates for some blood cancers from nearly zero to more than
85 percent. However, patients receiving bone marrow transplants are
at high risk of developing acute GVHD, a life-threatening
complication that occurs when the transplanted donor cells attack
the patient’s organs, including the skin, GI tract, liver, lungs,
and eyes.
It is estimated that up to 50% of patients who
undergo a bone marrow transplant from a 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.
Kalytera’s Phase 2 clinical study is an open
label, multicenter study to evaluate multiple doses of CBD for the
prevention of acute GVHD following allogeneic hematopoietic cell
transplantation, commonly referred to as bone marrow
transplantation. The study will evaluate the PK profile, safety,
and efficacy of CBD at doses of 75, 150, and 300 mg BID.
CBD is a non-psychotropic ingredient of cannabis
that does not cause euphoria or cognitive effects. The formulation
of CBD that Kalytera is evaluating for the prevention of acute GVHD
is a proprietary formulation that is designed to improve product
stability and absorption after oral dosing.
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 its
CBD products for prevention and treatment of acute GVHD, each of
which could accelerate the approval process for these products.
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
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