Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the
"
Company" or "
Kalytera") today
announced the initiation of a Phase 2 clinical study evaluating the
use of cannabidiol ("
CBD") in the prevention of
graft versus host disease ("
GVHD"). Kalytera
also announced today that it has entered into an agreement with The
Salzman Group of Israel, under which The Salzman Group will, among
other things, accept common shares of Kalytera in payment for its
services in connection with the Phase 2 study, subject to TSX
Venture Exchange approval.
Initiation of Phase 2 Clinical Study in
Prevention of Graft Versus Host Disease
The Phase 2 study is designed to assess the
pharmacokinetic and safety profile of multiple doses of CBD for the
prevention of GVHD. The study is expected to enroll 36 patients
following allogeneic hematopoietic cell transplantation, and will
take place at Beilinson Hospital, and one other major medical
center in Israel. Results of the study are expected by Q3 2018.
The Company anticipates that, following
completion of the Phase 2 study, it will initiate the Phase 3 study
as quickly as possible.
“We are focused on advancing this program from
its current Phase 2 status to Phase 3 status as quickly and
efficiently as possible, and the initiation of this Phase 2 study
is an important and essential step in that process,” said Robert
Farrell, President and CEO of Kalytera.
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.
Other experts in the field of GVHD who will
advise the Company with regard to the study include 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; and Rafael Duarte, M.D.,
Ph.D., Director of the Haematopoietic Transplant Programme at the
Catalan Oncology Institute in Barcelona.
Agreement with The Salzman Group
Kalytera also announced today that it has
entered into an agreement with The Salzman Group (the
“Agreement”), under which The Salzman Group will
provide clinical study management services in relation to the Phase
2 study, including chemistry, manufacturing and controls
("CMC") analytics, as well as
stability studies, toxicology studies and drug-drug interaction
studies, all of which will be required by the FDA to be completed
prior to initiation of a Phase 3 pivotal study. The estimated
cost of these services is expected to be approximately $1,240,000
over an 11-month period, and Salzman Group has agreed that it will
accept payment in common shares of Kalytera for these services,
subject to TSX Venture Exchange approval.
"We are pleased to establish this important
funding and clinical studies management agreement with The Salzman
Group,” said Robert Farrell, President and CEO of Kalytera. “The
Salzman Group is an international pharmaceutical development firm
with a strong track record and over two decades of comprehensive
experience in drug development, including drug design, process
scale-up, formulation, efficacy modeling and design and management
of clinical studies. This agreement with The Salzman Group will
enable Kalytera to advance our Phase 2 program in the prevention of
GVHD, and position us to begin Phase 3 clinical testing during the
second-half of next year.”
The Salzman Group will invoice Kalytera for this
work in fixed amounts, on a monthly basis as specified in the
Agreement, and Kalytera will have the option to make payments in
either cash or common shares of the Company ("Common
Shares"), in accordance with applicable securities laws
and TSX Venture Exchange policies. If Kalytera chooses to pay
any such invoice through the issuance of Common Shares, the number
of shares of Common Shares that will be issued will be based on a
ten percent (10%) discount from the closing price of Kalytera’s
Common Shares on the TSX Venture Exchange on the trading day prior
to the day that Kalytera gives notice to the Salzman Group that it
intends to pay the invoice in Common Shares. The Salzman Group will
establish an irrevocable selling agreement with its broker to sell
such shares on each of the three trading days following deposit of
such shares in its brokerage account.
About Kalytera
TherapeuticsKalytera Therapeutics, Inc.
("Kalytera") 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, with an initial focus on graft versus host
disease (“GVHD”).
Kalytera also intends to develop a new class of
proprietary cannabidiol ("CBD") therapeutics. CBD
is a versatile compound that has shown activity against a number of
pharmacological targets. However, there are limitations associated
with natural CBD, including its poor oral bioavailability. Kalytera
will seek to develop 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 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 and the risk that the TSX Venture Exchange may
not approve the shares for services arrangement on the terms
described or at all. 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 are expressly qualified
by this cautionary statement and are 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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