Phio Pharmaceuticals Announces Positive Recommendation from Safety Monitoring Committee (SMC) of Phase 1b Clinical Study of Phio's Lead Compound PH-762
Phio Pharmaceuticals (NASDAQ: PHIO) announced that its Safety Monitoring Committee (SMC) has reviewed safety data from the first dose cohort of the Phase 1b clinical trial of its lead compound, PH-762. This trial evaluates the safety and tolerability of intratumoral PH-762 in cutaneous squamous cell carcinoma (stages 1, 2, 4), melanoma (stage 4), and Merkel cell carcinoma (stage 4). Encouragingly, no dose-limiting toxicities or significant treatment-emergent adverse events were reported. The SMC has recommended escalating to the next dose concentration and enrolling the next cohort.
The Phase 1b study (NCT 06014086) utilizes Phio’s INTASYL™ siRNA gene silencing technology aimed at enhancing the efficacy of immune cells in tumor destruction. Chief Medical Officer Mary Spellman MD emphasized the importance of safety and efficacy data in guiding the continued development of PH-762 and expressed optimism about further enrollment in the study.
- No dose-limiting toxicities observed in the initial cohort.
- No clinically relevant treatment-emergent adverse events reported.
- SMC recommended dose escalation and further enrollment.
- Intratumoral injections of PH-762 were well tolerated.
- Positive feedback from the Safety Monitoring Committee boosts confidence in the ongoing trial.
- Potential advancement in treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
- Utilizes proprietary INTASYL™ siRNA technology to enhance immune cell efficacy.
- Ongoing Phase 1b trial implies PH-762 is still in early stages of development.
- Lack of efficacy data as focus remains on safety and tolerability at this stage.
Insights
Phio Pharmaceuticals' lead compound, PH-762, showing a positive safety profile in its Phase 1b clinical trial is significant for the company and the medical field. PH-762 leverages siRNA technology to enhance immune cell effectiveness against tumor cells. Importantly, the initial cohort did not experience dose-limiting toxicities, a positive indicator for safety and tolerability.
Intratumoral injections—delivered directly into the tumor—are being used here, which can potentially lead to more effective and localized treatment with fewer systemic side effects compared to traditional methods. This progress could be groundbreaking, especially for stages 1, 2 and 4 cutaneous squamous cell carcinoma, stage 4 melanoma and stage 4 Merkel cell carcinoma, conditions that often have limited treatment options.
However, it’s important to temper expectations. Phase 1 trials primarily assess safety rather than efficacy. Thus, while the findings are promising, further trials are required to establish whether PH-762 will indeed become a viable treatment option. Patients and investors should note that early-stage clinical success does not always translate to final approval.
The positive recommendation from the Safety Monitoring Committee for PH-762's Phase 1b trial is a noteworthy milestone for Phio Pharmaceuticals. A favorable safety profile in early trials often boosts investor confidence, potentially leading to an increase in stock price. The absence of dose-limiting toxicities and clinically relevant adverse events in this cohort is a solid first step.
The immediate implication for retail investors is that such news might induce short-term stock volatility, primarily upward. However, from a long-term investment perspective, the road ahead involves more clinical stages and substantial capital investment. The successful progression to later trial phases will be crucial.
It’s also vital to consider the competitive landscape. The biotech sector is highly volatile and filled with numerous startups aiming to bring innovative therapies to market. Investors should continually monitor subsequent trial results and the company’s financial health to assess the viability of their investment.
The advancements reported by Phio Pharmaceuticals with PH-762 are pivotal for the company’s market position. The application of siRNA gene silencing technology represents a niche yet rapidly evolving area within oncology treatments. The biotechnology sector frequently witnesses shifts based on clinical trial milestones and Phio's positive safety data could carve out a competitive edge in a crowded market.
One unique aspect is the focus on neoadjuvant use, meaning treatment administered before the main treatment. This approach can significantly impact treatment outcomes by shrinking tumors pre-surgery or other major treatments, potentially making them more manageable and improving prognosis.
From a market adoption standpoint, assuming PH-762 continues to show strong safety and efficacy, it has the potential to impact the treatment paradigm for specific types of cancer. However, investors should be cautious about broader market implications until more comprehensive efficacy data is available.
Intratumoral PH-762 has encouraging safety profile in the initial cohort
Escalation to proceed to next dose concentration
Marlborough, Massachusetts--(Newsfile Corp. - May 28, 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 that a Safety Monitoring Committee (SMC) reviewed safety data from the first dose cohort treated in the Phase 1b clinical trial with Phio's lead compound PH-762. Based on these findings, the SMC recommended the escalation to the next dose concentration.
Phio's ongoing Phase 1b clinical study (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.
There have been no dose-limiting toxicities, or clinically relevant treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The intratumoral injections have been well tolerated. The SMC has recommended dose escalation and enrollment of the next planned cohort in the clinical study.
"Safety and efficacy data from our clinical trial will establish the roadmap for continued development of PH-762," said Mary Spellman MD, Phio's acting Chief Medical Officer. "We are pleased with continued interest in the potential therapy and look forward to continued enrollment in the clinical study."
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. 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
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