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ProtoKinetix Updates Progress Toward Clinical Trial Application for AAGP™
ST. MARYS, W. Va.–(BUSINESS WIRE)–ProtoKinetix, Incorporated (OTCQB: PKTX) (the “Company” or “ProtoKinetix”) (www.protokinetix.com) is pleased to update its stockholders on the progress that it has made toward the application to conduct clinical trials in Canada with Health Canada.AmbioPharm, Inc. of North Augusta, South Carolina, has completed the first run of Good Manufacturing Practice (GMP) of …
ST. MARYS, W. Va.–(BUSINESS WIRE)–ProtoKinetix, Incorporated (OTCQB: PKTX)
(the “Company” or “ProtoKinetix”) (www.protokinetix.com)
is pleased to update its stockholders on the progress that it has made
toward the application to conduct clinical trials in Canada with Health
Canada.
AmbioPharm,
Inc. of North Augusta, South Carolina, has completed the first run
of Good Manufacturing Practice (GMP) of AAGP™. AmbioPharm has shipped
AAGP™ to ITR
Canada of Montreal, Quebec, to commence toxicology studies under the
Good Laboratory Practice (GLP).
AmbioPharm has also shipped AAGP™ to Nelson
Laboratories of Salt Lake City, Utah, to commence bio burden and
development of sterility protocols under GLP.
These above tests will provide critical data for the Investigator’s
Brochure (IB), a component of the clinical trial application to Health
Canada. The IB is a multidisciplinary document that summarizes the main
elements of an entire development program to date. Although the IB also
serves other purposes, it is written to enable investigators conducting
clinical trial studies to assess the risks and benefits associated with
an investigational product.
To subscribe to our new, automated News Release Email Service, please
visit our website: www.protokinetix.com
About ProtoKinetix
ProtoKinetix, Incorporated is a molecular biotechnology company that has
developed and patented a family of hyper stable, potent glycopeptides
(AAGP™) that enhance both engraftment and protection of transplanted
cells used in regenerative medicine. Due to the results achieved over
the last four years of testing the company is now preparing a submission
to enter into a Phase 1/2 human clinical trial. Additional studies will
be expanded to include whole organ transplantation and other cell
therapies used in regenerative medicine.
Cautionary Note Regarding Forward-Looking Statements
The information discussed in this press release includes “forward
looking statements” within the meaning of Section 27A of the Securities
Act of 1933 (the “Securities Act”) and Section 21E of the Securities
Exchange Act of 1934 (the “Exchange Act”). All statements, other
than statements of historical facts, included herein concerning, among
other things, planned capital expenditures, future cash flows and
borrowings, pursuit of potential acquisition opportunities, our
financial position, business strategy and other plans and objectives for
future operations, are forward looking statements. These forward looking
statements are identified by their use of terms and phrases such as
“may,” “expect,” “estimate,” “project,” “plan,” “believe,” “intend,”
“achievable,” “anticipate,” “will,” “continue,” “potential,” “should,”
“could,” and similar terms and phrases. Although we believe that
the expectations reflected in these forward looking statements are
reasonable, they do involve certain assumptions, risks and uncertainties
and are not (and should not be considered to be) guarantees of future
performance. Among these risks are those set forth in a Form 10-K
filed on March 30, 2016. It is important that each person reviewing this
release understand the significant risks attendant to the operations of
ProtoKinetix. ProtoKinetix disclaims any obligation to update any
forward-looking statement made herein.
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