Phio Pharmaceuticals Announces First US Patient Enrolled in Phase 1B Clinical Trial with Intratumoral PH-762 anti-PD-1 Therapy for Treatment of Skin Carcinomas
November 09 2023 - 7:30AM
Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage
biotechnology company whose proprietary INTASYL™ RNAi platform
technology is designed to make immune cells more effective in
killing tumor cells, today announced that the first patient has
been dosed in the Phase 1b clinical trial of PH-762, an INTASYL
compound that reduces the expression of PD-1, a protein that
inhibits T cells’ ability to kill cancer cells. This clinical trial
is designed to evaluate the safety and tolerability of neoadjuvant
use of intratumorally injected PH-762, assess the tumor response,
and determine the dose or dose range for continued study of PH-762
in patients with cutaneous squamous cell carcinoma, melanoma, or
Merkel cell carcinoma.
“The initiation of enrollment in this trial
represents a milestone as we develop PH-762 for the treatment of
squamous cell and other skin cancers,” said Phio’s President and
CEO Robert Bitterman. “We are optimistic that this novel,
alternative immuno-oncology therapy may offer patients and their
care providers, enhanced therapeutic outcomes while minimizing
invasive intervention.”
The Phase 1b trial is a non-comparative study of
neoadjuvant monotherapy using PH-762 in adult patients with
cutaneous squamous cell carcinoma, melanoma, or Merkel cell
carcinoma. The study treatment consists of four intratumoral
injections of PH-762 at weekly intervals within a single tumor
lesion. Excision of the tumor occurs approximately two weeks
following the fourth intratumoral dose of PH-762. Escalating doses
of PH-762 are to be tested in separate cohorts. The clinical study
is expected to enroll up to 30 patients and will be conducted
across 4 to 6 centers in the United States. More information about
this clinical trial is available at clinicaltrials.gov
(identifier: NCT06014086).
About Phio Pharmaceuticals
Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a
clinical stage biotechnology company whose proprietary INTASYL™
RNAi technology is designed to make immune cells more effective in
killing tumor cells. INTASYL is the only self-delivering RNAi
technology focused on immuno-oncology therapeutics. INTASYL drugs
precisely target specific proteins that reduce the body's ability
to fight cancer, without the need for specialized formulations or
drug delivery systems.
For additional information, visit the Company's
website, www.phiopharma.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
words such as "intends," "believes," "anticipates," "indicates,"
"plans," "expects," "suggests," "may," "would," "should,"
"potential," "designed to," "will," "ongoing," "estimate,"
"forecast," "target," "predict," "could" and similar references,
although not all forward-looking statements contain these words.
These statements are based only on our current beliefs,
expectations and assumptions and are subject to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control.
Examples of forward looking statements include statements regarding
the timing of, as well as the progress of, and data reported from,
this Phase 1b clinical trial and the therapeutic potential of
PH-762 to treat patients with cutaneous squamous cell carcinoma,
melanoma, or Merkel cell carcinoma. Our actual results may differ
materially from those indicated in the forward-looking statements
as a result of a number of important factors, including, but not
limited to, the impact to our business and operations by
inflationary pressures, rising interest rates, recession fears, the
development of our product candidates, results from our preclinical
and clinical activities, our ability to execute on business
strategies, our ability to develop our product candidates with
collaboration partners, and the success of any such collaborations,
the timeline and duration for advancing our product candidates into
clinical development, the timing or likelihood of regulatory
filings and approvals, the success of our efforts to commercialize
our product candidates if approved, our ability to manufacture and
supply our product candidates for clinical activities, and for
commercial use if approved, the scope of protection we are able to
establish and maintain for intellectual property rights covering
our technology platform, our ability to obtain future financing,
market and other conditions and those identified in our Annual
Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q
under the caption "Risk Factors" and in other filings the Company
periodically makes with the SEC. Readers are urged to review these
risk factors and to not act in reliance on any forward-looking
statements, as actual results may differ from those contemplated by
our forward-looking statements. Phio does not undertake to update
forward-looking statements to reflect a change in its views, events
or circumstances that occur after the date of this release, except
as required by law.
Contact:
Phio Pharmaceuticals Corp.ir@phiopharma.com
PR Contact:
Michael AdamsBridge View Mediapr@phiopharma.com
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