Phio Pharmaceuticals Announces Addition of Clinical Trial Sites at Banner MD Anderson Cancer Center, The George Washington University, and Integrity Research
Phio Pharmaceuticals Corp. announced the addition of three clinical trial sites for its Phase 1b study of PH-762, an INTASYL compound silencing PD-1 to enhance T cells' ability to kill cancer cells. The study aims to evaluate safety, tolerability, tumor response, and dosing for patients with skin cancers.
The expansion of clinical trial sites for Phio Pharmaceuticals' Phase 1b study of PH-762 is a significant development in the field of immuno-oncology. PH-762 is an innovative INTASYL compound that targets PD-1, a crucial checkpoint inhibitor that, when silenced, can enhance the ability of T cells to combat tumor cells. This mechanism is particularly relevant for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma, which are the focus of this trial.
From a clinical perspective, the inclusion of multiple reputable institutions in the study ensures a diverse patient population, which is critical for assessing the safety and efficacy of PH-762 across different demographics. The neoadjuvant setting of the trial is also noteworthy, as treatments given prior to the main treatment can shrink tumors and may improve surgical outcomes. The outcomes of this study have the potential to shape future therapeutic strategies and contribute to personalized medicine in oncology.
As a Medical Research Analyst, it's important to emphasize the strategic importance of broadening the geographic reach of a clinical trial. By engaging additional sites, Phio Pharmaceuticals is likely to accelerate patient enrollment and enhance the statistical power of the study. This is crucial for a Phase 1b trial, which aims to determine the optimal dose for further research.
Moreover, the study's design to evaluate tumor response and safety profiles will provide valuable data for subsequent phases of clinical development. The ability to silence PD-1 intratumorally could represent a significant advancement over existing systemic therapies, potentially reducing side effects and improving patient outcomes. Investors and stakeholders will be closely monitoring the results for indications of PH-762's efficacy and tolerability, which could have a profound impact on the company's valuation and future prospects.
From a market perspective, advancements in gene silencing technologies like INTASYL™ have the potential to disrupt the oncology treatment landscape. The successful development and eventual approval of PH-762 could position Phio Pharmaceuticals as a key player in a market that is increasingly focused on precision medicine and targeted therapies. As the trial progresses, positive data could attract partnership opportunities and increase investor confidence.
However, it is essential to consider the competitive environment. The immuno-oncology space is crowded, with many companies vying for a share of the market. The success of PH-762 will depend not only on its clinical efficacy but also on its ability to differentiate itself from other therapies. Analysts will need to monitor the evolving landscape and consider how emerging data from PH-762's trials stack up against alternative treatments in terms of efficacy, safety and cost-effectiveness.
03/13/2024 - 02:00 PM
--Four sites across the U.S. are now engaged in the Phase1b study
MARLBOROUGH, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- 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 three clinical trial sites for its Phase 1b study of PH-762:
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 These sites join Centricity Research in Dublin, Ohio, which enrolled the study’s first patient in November.
The principal investigator at the George Washington University trial is Vishal Patel, M.D. and Mark Gimbel, M.D. at the Banner MD Anderson Cancer Center trial site. Kevin Donnelly MD is principal investigator at Centricity Research.
“We are delighted to be able to include these sites, all of whom have an interest in immuno-oncology and an exceptional reputation in conducting trials in skin cancer,” said Robert Bitterman, CEO of Phio Pharmaceuticals. “Additionally, their inclusion expands our geographic reach facilitating broader patient inclusion in the clinical trial.”
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.
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: ir@phiopharma.com
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What is the purpose of Phio Pharmaceuticals Corp.'s Phase 1b study for PH-762?
The Phase 1b study aims to evaluate the safety, tolerability, tumor response, and dosing of PH-762, an INTASYL compound that silences PD-1 to enhance T cells' ability to kill cancer cells, in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
Which sites have been added to the Phase 1b study of PH-762 by Phio Pharmaceuticals Corp.?
The three new clinical trial sites added are The George Washington University—Medical Faculty Associates in Washington, D.C., Banner MD Anderson Cancer Center in Gilbert, Arizona, and Integrity Research Clinical Associates in Delray Beach, Florida.
Who are the principal investigators at the George Washington University and Banner MD Anderson Cancer Center trial sites?
The principal investigator at the George Washington University trial is Vishal Patel, M.D., and Mark Gimbel, M.D. is the principal investigator at the Banner MD Anderson Cancer Center trial site.
What is the role of Centricity Research in the Phase 1b study of PH-762?
Centricity Research in Dublin, Ohio, enrolled the study's first patient in November, with Kevin Donnelly, MD, as the principal investigator.
What is the target of PH-762 in the Phase 1b study?
PH-762 targets PD-1, a protein that inhibits T cells' ability to kill cancer cells, in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
