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 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.
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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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160512005894/en/
ProtoKinetix
Clarence E. Smith, 304-299-5070
President
and Chief Executive Officer
[email protected]
Twitter:
@ProtoKinetix
Source: ProtoKinetix, Incorporated
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