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Phio Pharmaceuticals Announces Addition of Clinical Trial Site for its Phase 1b study of PH-762

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Phio Pharmaceuticals (NASDAQ: PHIO) announced the inclusion of the University of Pittsburgh Medical Center (UPMC) Department of Dermatology as a clinical trial site for its Phase 1b study of PH-762, bringing the total to five participating sites. This trial involves adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma and aims to assess the safety and tolerability of PH-762, an INTASYL compound that silences PD-1, enhancing T cell ability to kill cancer cells. The study recently received a positive safety recommendation for dose escalation and is currently enrolling patients for the second cohort. Other participating sites include The George Washington University, Banner MD Anderson Cancer Center, Integrity Research Clinical Associates, and Centricity Research.

Positive
  • Addition of UPMC as a clinical trial site enhances trial capacity and geographical reach.
  • Received positive safety recommendation from the Safety Monitoring Committee to escalate the dose.
  • Currently enrolling patients for the second cohort, indicating progress in the trial.
Negative
  • None.

Phio Pharmaceuticals' expansion to add the University of Pittsburgh Medical Center (UPMC) as a trial site broadens the reach of its Phase 1b study for PH-762. This inclusion is particularly notable as UPMC is a respected institution known for its dermatology research and clinical trials. The ongoing study focuses on the neoadjuvant monotherapy of PH-762, an INTASYL compound that targets PD-1, a protein inhibiting T cells from killing cancer cells effectively.

Expanding the study to five sites enhances the trial's robustness by capturing data from diverse populations and clinical practices across the U.S. This broad data collection can potentially accelerate the drug's development by ensuring comprehensive safety and efficacy data.

For retail investors, this development suggests a ramp-up in the clinical trial's pace, potentially leading to faster results and subsequent phases. It also underscores PHIO's commitment to advancing its core technology, which, if successful, could significantly impact the oncology sector.

The involvement of UPMC and other top-tier medical centers speaks to the study's credibility and the potential significance of PH-762 in treating cancers like cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The positive safety recommendation from the Safety Monitoring Committee is encouraging, as it suggests that the drug is well-tolerated in initial cohorts, permitting dose escalation.

Given the innovative nature of PH-762, which silences PD-1 to enhance T cell activity against tumors, these trials are critical. The success of this phase could pave the way for broader applications in oncology, particularly in cancers resistant to other forms of treatment. Moreover, the neoadjuvant approach, which involves treating the tumor before the main treatment, could improve overall outcomes if PH-762 proves effective.

Retail investors should note that while promising, the outcomes of clinical trials are uncertain. The expansion to five sites can be seen as a strategic move to ensure a thorough evaluation, critical in mitigating the risks associated with such innovative treatments.

Five sites across the U.S. are now participating in the Phase 1b study

Marlborough, Massachusetts--(Newsfile Corp. - July 8, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL® siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced the addition of the University of Pittsburgh Medical Center (UPMC) Department of Dermatology in Pittsburgh, PA as a clinical trial site for its lead product candidate, PH-762.

The Phase 1b study recently received a positive safety recommendation from the Safety Monitoring Committee to escalate the dose in the next phase of the study. The clinical trial is currently enrolling patients for the 2nd cohort.

The UPMC Department of Dermatology joins four other sites engaged in the clinical study: The George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio.

"We are excited to conduct our study with these five clinical sites, all of whom have a very keen interest in immuno-oncology and are leading centers in skin cancer," said Robert Bitterman, CEO of Phio Pharmaceuticals.

PH-762 is an INTASYL compound that silences PD-1, a protein that inhibits T cells' ability to kill cancer cells. 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 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.

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® siRNA gene silencing 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 Adams
Bridge View Media
adams@bridgeviewmedia.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/215533

FAQ

What is Phio Pharmaceuticals' latest update on the PH-762 Phase 1b study?

Phio Pharmaceuticals added UPMC as a clinical trial site, making five sites in total, and received a positive safety recommendation for dose escalation.

Which clinical sites are participating in Phio's Phase 1b study of PH-762?

The participating sites are UPMC, The George Washington University, Banner MD Anderson Cancer Center, Integrity Research Clinical Associates, and Centricity Research.

What is the focus of the Phase 1b study for PH-762?

The study focuses on evaluating the safety and tolerability of PH-762 as a neoadjuvant monotherapy in adults with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.

What recent milestone did the PH-762 Phase 1b study achieve?

The study received a positive safety recommendation from the Safety Monitoring Committee to escalate the dose and is enrolling patients for the second cohort.

What is PH-762 and its mechanism of action?

PH-762 is an INTASYL compound that silences PD-1, a protein that inhibits T cells' ability to kill cancer cells, enhancing the immune response against tumors.

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