Kalytera Therapeutics, Inc. (TSXV:KALY) (“Kalytera”) is pleased to
announce encouraging results from a Phase 2a study evaluating the
safety and efficacy of cannabidiol (“CBD”), a primary constituent
of the marijuana plant, for the treatment of acute (Grade 3-4)
Graft versus Host Disease (“GvHD”).
In the present study, ten patients with acute (Grade 3-4) GvHD
that was refractory to standard treatment with high-dose steroids,
were administered daily doses of CBD for up to three months. Nine
of the ten patients enrolled in the study responded to treatment;
seven achieved complete remission, and two achieved a near-complete
response. Six patients are still alive with a median follow-up
period of 13 months (range 5-30 months). Two patients (one with
Grade 3 GvHD and one with Grade 4 GvHD) died from leukemia relapse,
and two patients (one with Grade 3 GvHD and one with Grade 4 GvHD)
died from GvHD-related infectious complications. No patient deaths
were determined to be associated with CBD treatment.
Historical control data gathered at the same clinical site, the
Rabin Medical Center, in Petah Tikva, Israel, examined 305 patients
who underwent allogeneic hematopoietic cell transplantation without
CBD therapy between May 2007 and December 2016. Of these 305
patients, 32 developed acute (Grade 3-4) GvHD. Among 12 patients
with Grade 3 GvHD, three patients responded to first-line high-dose
steroids and are alive, six patients died within four months from
GvHD and its complications, one patient died after 12 months from a
second malignancy, and two patients who were refractory to steroids
are still alive (one patient after more than two years and one
patient at three months). Among 20 patients with Grade 4 GvHD, all
died within four months from GvHD and its complications.
In the present study, among ten patients with steroid-refractory
acute (Grade 3-4) GvHD, 90% achieved either complete remission
(“CR”) or a near-complete response with CBD. Two patients died from
GvHD and its complications (one patient with Grade 4 GvHD who
achieved CR with CBD, but had a GvHD flare-up upon uninformed
cessation of CBD; another patient with Grade 3 GvHD had to stop CBD
after four days of treatment following a severe infection, thus
efficacy could not be evaluated). These preliminary results compare
favorably with the results of the historical control group of 29
patients with steroid-refractory Grade 3-4 GvHD, among which 26
patients died from GvHD and its complications.
The present study was conducted by Talent Biotechs, a privately
held, Israeli-based developer of CBD therapeutics, that was
recently acquired by Kalytera.
The ability to treat GvHD is a major unmet need. GvHD remains a
major cause of morbidity and mortality after allogeneic
hematopoietic cell transplantation (“HCT”). Typically, only 60% of
patients respond to first-line therapy with high-dose steroids. The
12-month mortality rate among patients with steroid-refractory
Grade 3 and 4 GvHD exceeds 60% and 80%, respectively.
The U.S. FDA has recommended that the sponsor of the study apply
for both Breakthrough Therapy and Fast Track Designations, each of
which could accelerate the approval process.
In addition, the successful results of an earlier Phase 2a
clinical trial evaluating the safety and efficacy of CBD in the
prevention of acute GvHD have already been published.
“We are very excited about these results and the benefits to
patients with no other treatment options,” said Dr. Andrew L.
Salzman, CEO of Kalytera. “These results are significant in this
disease setting, and we look forward to starting a
comparator-controlled, randomized, multicenter Phase 2b study in
the near-future.”
Conference Call and Webcast
A conference call and webcast will be held on Thursday, February
23, 2017 at 12:00 PM ET to discuss the study results. Conference
call and webcast information is as follows:
- Date: Thursday, February 23, 2017
- Time: 12:00 PM ET
- Conference
Call: http://dpregister.com/10101838 (Register to
receive dial-in instructions)
-
Webcast: http://services.choruscall.com/links/kaly170223.html
(Allow at least ten minutes to access the site before the
webcast begins)
The conference call and webcast will be available for replay on
the Kalytera website.
About Graft versus Host Disease
Hematopoietic cell transplantation (“HCT”) is a procedure where
the stem cells of the bone marrow or peripheral blood of a healthy
donor are transplanted into a new host after chemotherapy or
radiation. This is a lifesaving procedure for many diseases of the
blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin
lymphoma, multiple myeloma, sickle cell anemia, and thalassemia.
There were over 8,000 HSCT procedures in the U.S. in 20141 and
the use of HCT procedures is expected to continue to increase.
While HCT procedures can be lifesaving, they pose many dangerous
side effects, including infection and GvHD.
GvHD is an orphan disease and multisystem disorder that occurs
when the transplanted cells from a donor (“the graft”) recognize
the transplant recipient (“the host”) as foreign. This interaction
initiates an immune reaction that causes the transplanted donor
cells to attack the patient’s organs, including the skin,
gastrointestinal tract, liver, lungs, eyes, oral cavity, heart,
nervous system and other organs. This reaction can occur within
days after the transplant (acute GvHD) or months to years
after HCT (chronic GvHD).
GvHD can be mild, moderate, severe, and even life threatening.
Patients with acute GvHD may suffer from rashes and blistering of
the skin, nausea, vomiting, abdominal cramps accompanied by
diarrhea and jaundice. Generally, acute reactions are more severe
and life threatening.
GvHD is a major cause of morbidity and mortality following HCT.
Researchers estimate that even with intensive prophylaxis with
immunosuppressive treatments, 30-50% of patients transplanted from
fully matched sibling donors and 50-70% of patients transplanted
from unrelated donors will develop some level of GvHD2. The GvHD
market was valued at $295M across the six major markets in 2013,
and is expected to grow to $544M by 2023, according to research and
consulting firm GlobalData3.
Standard of Care: Prevention and Treatment of
GvHD
The first step in prevention of GvHD is the selection of donor
cells that closely match the genetics of the immune system of the
transplant recipient, ideally a sibling donor. From there, the
patient relies on drugs that have been developed to prevent or
treat GvHD. Medicinal prevention of acute GvHD is dependent on
immunosuppression of the donor cells, either pharmacologically or
through T cell depletion. Common drugs include methotrexate,
cyclosporine tacrolimus, sirolimus, mycophenolate mofetil and ATG.
Preventive measures and clinical practices vary by
institution4.
Treatment of GvHD involves pharmacologic suppression of the
graft’s immune cell activation and reestablishment of donor-host
immune-tolerance. Most patients are prescribed corticosteroids,
which directly suppress the donor’s immune cell attack on host
tissue, but also raise the risk of infection and cancer relapse. As
with prevention, the optimal drug strategy for GvHD is not well
defined. Less than 60% of patients with GvHD respond to
corticosteroids, putting many at risk for fatal outcomes5.
CBD and GvHD
CBD is a major component of Cannabis sativa, commonly known as
marijuana. CBD possesses potent anti-inflammatory and
immunosuppressive properties. Unlike the other major component of
cannabis, tetrahydrocannabinol (“THC”), CBD is non-psychoactive and
is well tolerated by humans when taken over extended periods of
time6. CBD has shown benefit in a number of models of inflammatory
diseases including diabetes7, rheumatoid arthritis8, multiple
sclerosis9, and inflammatory bowel disease10.
____________________________
1 Center for International Blood and Marrow
Transplant Research (CIBMTR) HCT Trends and Survival
Data 2 Weisdorf D. GVHD the nuts and bolts.
Hematology Am Soc Hematol Educ Program. 2007;:62-7. 3
GlobalData Report (2015) 4 Ruutu
T, Van biezen A, Hertenstein B, et al. Prophylaxis and treatment of
GVHD after allogeneic haematopoietic SCT: a survey of centre
strategies by the European Group for Blood and Marrow
Transplantation. Bone Marrow Transplant.
2012;47(11):1459-64. 5 Weisdorf D. GVHD the
nuts and bolts. Hematology Am Soc Hematol Educ Program.
2007;:62-7. 6 Mechoulam R, Peters M,
Murillo-rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem
Biodivers. 2007;4(8):1678-92. 7 Weiss L, Zeira M,
Reich S, et al. Cannabidiol lowers incidence of diabetes in
non-obese diabetic mice. Autoimmunity.
2006;39(2):143-51. 8 Malfait AM, Gallily R,
Sumariwalla PF, et al. The nonpsychoactive cannabis constituent
cannabidiol is an oral anti-arthritic therapeutic in murine
collagen-induced arthritis. Proc Natl Acad Sci USA.
2000;97(17):9561-6. 9 Trojano M. Advances in the
management of MS symptoms: real-life evidence. Neurodegener Dis
Manag. 2015;5(6 Suppl):19-21. 10 Schicho R, Storr M.
Topical and systemic cannabidiol improves trinitrobenzene sulfonic
acid colitis in mice. Pharmacology. 2012;89(3-4):149-55.
About Kalytera Therapeutics
Kalytera (TSXV:KALY) is pioneering the development of a next
generation of cannabinoid therapeutics. Through its proven
leadership, drug development expertise, and intellectual property
portfolio, Kalytera seeks to establish a leading position in the
development of novel cannabinoid medicines for a range of important
unmet medical needs.
Kalytera is focused first on developing a new class of
proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable
compound that has shown activity against a number of
pharmacological targets. However, there are limitations associated
with natural CBD, including its poor oral bioavailability and short
half-life. Kalytera is developing innovative CBD formulations and
prodrugs in an effort to overcome these limitations, and to target
specific disease sites within the body. Kalytera intends to file
composition of matter and method of use patents covering its novel
inventions, with the goal of limiting future competition.
- Website Home: https://kalytera.co/
- News and Insights: https://kalytera.co/news/
- Investors: https://kalytera.co/investors/
Cautionary Note
The results of the Phase 2(a) study described herein are from a
limited study of only ten patients with varying results and may not
be representative of future results.
Investors are cautioned that any information released or
received with respect to the proposed Transaction may not be
accurate or complete and should not be relied upon. Trading in the
securities of Kalytera should be considered highly speculative.
Neither the TSXV nor its Regulation Services Provider
(as that term is defined in the policies of the TSXV) has in any
way passed upon the merits of the proposed Transaction and
associated transactions and neither of the foregoing entities has
in any way approved or disapproved of the contents of this press
release.
Neither the TSXV nor its Regulation Services Provider
(as that term is defined in the policies of the TSXV) accepts
responsibility for the adequacy or accuracy of this press
release.
Forward-Looking Statement Disclosure
This news release may contain “forward-looking information”
within the meaning of applicable securities laws. The information
about Talent contained in the press release has not been
independently verified by Kalytera. Although Kalytera believes in
light of the experience of its officers and directors, current
conditions and expected future developments and other factors that
have been considered appropriate, that the expectations reflected
in this forward-looking information are reasonable, undue reliance
should not be placed on them because Kalytera can give no assurance
that they will prove to be correct. 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, that the results
of future clinical studies may be inconsistent with those produced
in the studies described herein. The statements in this press
release are made as of the date of this release. Kalytera
undertakes no obligation to comment on analyses, expectations or
statements made by third-parties in respect of Kalytera, its
securities, or its respective financial or operating results (as
applicable). Kalytera disclaims any intent or obligation to update
publicly any forward-looking information, whether as a result of
new information, future events or results or otherwise, other than
as required by applicable securities laws.
Company Contact
Robert Farrell
President, COO and CFO
Phone: (888) 861-2008
Email: ir@kalytera.co
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