PharmaGap Completes Arrangements for Bladder Cancer Test Program
July 19 2011 - 7:00AM
Marketwired
PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF)("PharmaGap" or "the
Company") today announced that it has completed contractual
arrangements and program design for model development and testing
of its lead cancer drug GAP-107B8 using human bladder cancer in
rats with ITR Laboratories Canada Inc. (ITR) of Baie d'Urfe Quebec.
The test program will be in three phases: first the development
and validation of an intravesical bladder cancer model in rats,
followed by an MTD (Maximum Tolerated Dose) study required to
determine dose ranges for the third phase, which will be an
assessment of efficacy of the Company's cancer drug GAP-107B8 in
rats, using intravesical administration. Intravesical
administration - direct injection of the drug into the bladder - is
a clinically recognized route of administration for treatment of
bladder cancer in humans.
Phase I
The objective of the first phase, anticipated to be completed by
the end of September, is to develop an in vivo orthotopic model for
human urinary bladder epithelial carcinomas. Three human bladder
cancer cell lines representative of varying degrees of malignancy,
all of which have been shown to be significantly inhibited by
treatment with GAP-107B8 liposomal peptide formulations in vitro,
will be screened in this model. Orthotopic refers to the
establishment of the bladder cancer in the bladder itself,
mimicking directly the in-life experience, which is a key factor in
assessment of a drug's effectiveness. Epithelial carcinoma of the
bladder represents over 75% of all the types of bladder carcinomas
described in humans. The presence and number of solid tumors
(single or multiple sites) within the urinary bladder and tumor
size evaluation will be assessed using a high resolution in vivo
micro-imaging ultrasound system.
Phase II
Upon completion of the Phase I study, the second phase of
studies to be carried out at ITR will be an MTD (Maximum Tolerated
Dose) study to determine the dose ranges to be used in the Phase
III Efficacy study. This second phase will start following
completion of the Phase I study, and will lead directly into the
Phase III study.
Phase III
The third phase of the ITR studies will be an efficacy study to
demonstrate GAP-107B8's effect in slowing the rate of progression
of human bladder cancers implanted in the rat bladder using the
methodology developed in Phase I and the dose range established in
Phase II. This study is projected to be completed in Q4 of this
year. PharmaGap will use the results from these studies to guide
the Company's determination of the final drug formulation and
target for initial clinical trial application.
Dr. Ken Sokoll, Vice President Clinical Development and Chief
Operating Officer of PharmaGap, commented "PharmaGap is pleased to
be entering into a critical assessment phase with ITR, a fully GLP
capable contract research organization which has a wealth of
experience in designing and executing preclinical efficacy studies
and general toxicology protocols in support of clinical trial
applications. The team at ITR, with its pool of collaborators and
consultants, have direct experience in the development of animal
models for instilling drugs to the bladder and PharmaGap has drawn
upon this experience to assist in the design of the current bladder
cancer model study and for our ongoing pharmacokinetics and
toxicokinetics testing program."
About ITR Laboratories Canada Inc. (ITR)
ITR Laboratories Canada Inc. is an international Contract
Research Organization that provides clinical toxicology services
for the biotechnology and pharmaceutical industry in North America
and Europe. ITR offers services from planning and study program
design to study implementation and reporting for regulatory drug
filing. ITR Canada studies conducted are fully compliant with
GLP.
About PharmaGap Inc.
PharmaGap Inc. (TSX VENTURE: GAP), based in Ottawa, ON, is a
biotechnology company with a core focus on developing novel peptide
therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is
a novel peptide drug that has been shown to be highly cytotoxic to
numerous cancer types, including chemo-resistant cancers, in vitro.
For more information on PharmaGap please visit the Company's
website at www.pharmagap.com.
Forward Looking Statements
This news release contains certain statements that constitute
forward-looking statements as they relate to the Company and its
management. Forward-looking statements are not historical facts but
represent management's current expectations of future events, and
can be identified by words such as "believe", "expects", "will",
"intends", "plans", "projects", "anticipates", "estimates",
"continues", and similar expressions. Although management believes
that expectations represented in such forward-looking statements
are reasonable, there can be no assurance that they will prove to
be correct.
By their nature, forward-looking statements include assumptions
and are subject to inherent risks and uncertainties that could
cause actual future results, conditions, actions or events to
differ materially from those in the forward-looking statements. If
and when forward-looking statements are set out in this news
release, PharmaGap will also set out the material risk factors or
assumptions used to develop the forward-looking statements. Except
as expressly required by applicable securities laws, the Company
assumes no obligation to update or revise any forward-looking
statements. The future outcomes that relate to forward-looking
statements may be influenced by many factors, including, but not
limited to: results of ongoing product testing and development;
regulatory approvals required to complete development of products;
ability to manufacture product at quality and scale for human use
on an economically sound basis; patient reimbursement by private
and public health insurance programs; unintended side effects of
products; competitive products; product liability; intellectual
property; reliance on key personnel; risks of future legal
proceedings; income tax matters; availability and terms of
financing; distribution of securities; effect of market interest
rates on price of securities, and potential dilution.
Note: Neither the 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. No Securities Commission or other
regulatory authority having jurisdiction over PharmaGap has
approved or disapproved of the information contained herein. This
release contains forward looking statements that may not occur or
may change materially.
Contacts: Robert McInnis President & CEO (613) 990-9551
bmcinnis@pharmagap.com
Pharmagap Inc. (TSXV:GAP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Pharmagap Inc. (TSXV:GAP)
Historical Stock Chart
From Jul 2023 to Jul 2024