Kalytera Identifies Sites for Planned GvHD Clinical Trials; Company’s Research Gains Support at EBMT 2017
April 25 2017 - 8:30AM
Kalytera Therapeutics, Inc. (TSXV:KALY), a clinical-stage
biopharmaceutical company developing next-generation
cannabinoid-derived therapeutics, today announced that it has
developed the multi-center location component of the plan for the
proposed clinical trials to evaluate cannabidiol (“CBD”) for the
prevention and treatment of Graft versus Host Disease (“GvHD”).
Kalytera is developing this clinical trial plan with the intent of
obtaining FDA and EMEA approval for commercialization.
Kalytera expects to finalize and publish the details of its
clinical trial plan during the current quarter ending June 30,
2017. The plan will include the clinical trial designs, the
anticipated timelines for initiation and completion, as well as the
principal endpoints. The trials are intended to build on the
encouraging data seen in the recently completed Phase 2a Clinical
Trial.
In March 2017, Dr. Andrew L. Salzman, Kalytera’s Chief Executive
Officer, and Dr. Sari Prutchi Sagiv, Kalytera’s Vice President of
Scientific Operations, attended the 43rd Annual Meeting of the
European Society for Blood and Marrow Transplantation (“EBMT”)
in Marseilles, France. Prior to joining Kalytera, Dr. Sagiv led the
CBD-GvHD clinical research program at Talent Biotechs (“Talent”);
Talent was acquired by Kalytera in February 2017.
The EBMT Annual Meeting brings together thought leaders from
Europe and the world to explore the latest allogenic hematopoietic
stem cell transplantation (“HCT”) and cellular therapy research.
Having met and conferred with many of the leading authorities at
EBMT, Drs. Salzman and Sagiv have developed a multi-center site
plan for Kalytera’s planned clinical trials.
“Kalytera’s recent groundbreaking clinical trial with CBD as a
treatment for GvHD generated a great deal of excitement at EBMT,”
said Dr. Salzman. “The EBMT annual meeting brings together the
world’s leading authorities in HCT, a lifesaving procedure for a
number of diseases. HCT patients will benefit tremendously if the
risk of GvHD can be substantially reduced.
“Based on the encouraging results from our Phase 2a studies, we
believe that CBD has the potential to help patients with GvHD who
routinely fail first-line therapy with steroids. Kalytera intends
to undertake additional clinical studies in an effort to obtain
regulatory approval to use CBD for the treatment and prevention of
GvHD. Under Dr. Sagiv’s direction, we are working to complete our
next, major clinical trial plan. We look forward to publishing the
details of that plan this quarter.”
About GvHD and Kalytera’s CBD Clinical Research
ProgramGvHD is an FDA and EMEA-designated “orphan
disease.” GvHD is a major cause of morbidity and mortality after
HCT. It is a multisystem disorder that occurs when the transplanted
cells from a donor (“the graft”) recognize the transplant recipient
(“the host”) as foreign. 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. In February 2017, Kalytera
published results of a Phase 2a Clinical Study evaluating the
safety and efficacy of CBD for treating Acute GvHD, with promising
initial results.
About KalyteraKalytera (TSXV:KALY) is a
clinical-stage pharmaceutical company pioneering the development of
a next generation of cannabinoid therapeutics. Through its proven
leadership, drug development expertise, and growing 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 – with an initial focus on Graft
versus Host Disease (“GvHD”).
Kalytera is also 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 CBD, including its
poor oral bioavailability which greatly limits the efficacy of
medical marijuana edible products that contain a high level of CBD.
Kalytera is developing innovative CBD formulations and prodrugs
intended for commercialization as FDA and EMEA-approved
prescription medications in an effort to overcome these
limitations, and to target specific disease sites within the body.
Kalytera has filed composition of matter and method of use patents
covering its novel inventions.
Company ContactRobert FarrellPresident, COO and
CFOPhone: (888) 861-2008Email: ir@kalytera.co
Forward-looking Statement DisclaimerThis news
release may contain “forward-looking information” within the
meaning of applicable securities laws. 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. 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.
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