MARIETTA, Ohio–(BUSINESS WIRE)–#AAGP–ProtoKinetix, Incorporated (www.protokinetix.com)
(the “Company” or “ProtoKinetix”) (OTCQB:PKTX)
today announced reaching the midpoint of a Phase-1 first-in-human
clinical trial of AAGP® PKX-001 treated islet cells used in
conjunction with the Edmonton Protocol for the treatment of Type-1
diabetes. All six patients were recruited and treated under this
protocol. All primary safety objectives have been achieved at the
midpoint in all study participants. As such, the protocol will now be
amended to increase the number of participants in the trial with
additional secondary objectives added, including dose escalation to
establish optimization criteria for efficacy testing. In order to
satisfy the increased demand for the ongoing clinical trials and
expanding research collaborations, the Company has ordered an additional
200 grams of GMP grade PKX-001 molecule. This represents the most
significant scale-up of manufacturing in the Company’s history. Request
for approval of the amendments will be submitted to Health Canada by the
sponsor, the University of Alberta.
The trial is being led by Dr. James Shapiro, MD, PhD, FRCSC, MSM FCAHS,
AHS Director of Clinical Islet and Living Donor Liver Transplant
Programs, Canada Research Chair in Transplant Surgery and Regenerative
Medicine, Professor of Surgery, Medicine and Surgical Oncology,
University of Alberta.
Dr.
James Shapiro Bio
Dr.
James Shapiro Video
About
the Edmonton Protocol
“We found this anti-aging glycopeptide (AAGP®)
compound to have surprising efficacy in our preclinical testing with
human islets. Working with ProtoKinetix we have been able to rapidly
move forward to early pilot clinical testing in patients. Thus far, the
treatment has proved to be remarkably safe, and we are now in the
process of increasing the dose with the goal being to substantially
improve islet engraftment and survival in our islet transplant patients.
We are especially excited about this trial!” – Dr. James Shapiro
PKX-001 is the designation given to the lead drug product molecule of
the AAGP® family. Islet cell transplants are well recognized
as a viable and effective treatment for Type-1 diabetes. The PKX-001
study will treat islet cells prior to transplantation into human test
subjects. The clinical trials primary objective is the establishment of
patient safety. The study will also be making observations related to
indications of protection from tacrolimus toxicity and enhanced
engraftment survival of the transplanted cells. The trial follows
extensive preclinical evaluation in experimental models (to learn more,
refer to this link: Diabetes).
To obtain additional information and updates regarding this trial
please use the following link: Clinicaltrials.gov
– Islet Transplantation Using PKX-001.
About ProtoKinetix, Incorporated
ProtoKinetix 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,
organs, tissues and organs used in regenerative medicine. Due to the
results achieved over the last four years of testing, the University of
Alberta has begun Phase 1 human clinical trials. Additional studies will
be expanded to include whole organ transplantation and all therapies
that are being developed globally to date; diabetes, retinal
degeneration, cardiac repair and many other degenerative conditions. In
addition, we are studying the potential impact on several cancer
therapies.
For more Company information and to join our email listing visit our
website at ProtoKinetix.com.
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 12, 2019. 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 here.
This press release does not constitute or form a part of any offer or
solicitation to purchase or subscribe for securities in the United
States. The securities referred to herein have not been and will not be
registered under the Securities Act of 1933, as amended (the “Securities
Act”), or with any securities regulatory authority of any state or other
jurisdiction in the United States, and may not be offered or sold,
directly or indirectly, except pursuant to an exemption from or in a
transaction not subject to the registration requirements of the
Securities Act.
Contacts
Clarence E. Smith
President and Chief Executive Officer
Telephone:
304-299-5070
Email: csmith@protokinetix.com
Twitter:
@ProtoKinetix