Phio Pharmaceuticals Announces Positive Safety Monitoring Committee (SMC) Recommendation to Continue to Third Dose Cohort in its Clinical Study of PH-762
Phio's Lead Compound PH-762 demonstrates encouraging safety profile in 2nd cohort with recommendation to escalate to next dose concentration
Marlborough, Massachusetts--(Newsfile Corp. - December 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells. Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.
In this Phase 1b clinical study with PH-762, dosed intratumorally, the second cohort had enrolled 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision), the first two patients who completed treatment showed a complete response (100% tumor clearance and a partial response 90% clearance), respectively. Pathology data assessing efficacy data on the remaining 2 patients is forthcoming.
The intratumoral injections have been well tolerated. There have been no dose-limiting toxicities, or serious adverse events in participants receiving intratumoral PH-762.
"Safety and efficacy data from our clinical trial continues to be encouraging as we develop PH-762 for the treatment of cutaneous carcinomas," said Mary Spellman MD, Phio's acting Chief Medical Officer. "We look forward to continued enrollment in the clinical study."
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company advancing its proprietary INTASYL siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually any gene with high degree of specificity across a wide range of cell types and tissues. INTASYL is designed to enhance the ability of immune cells to more effectively kill tumor cells. INTASYL has also demonstrated enhancement adoptive cell therapy. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.
Phio's lead clinical program, PH-762, is an INTASYL compound that silences PD-1. PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the treatment of cutaneous SCC, melanoma and Merkel cell carcinoma in second quarter of 2023.
For additional information, visit the Company's website, www.phiopharma.com.
Forward-Looking Statements
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Contact: Phio Pharmaceuticals Corp. Jennifer Phillips: jphillips@phiopharma.com Corporate Affairs
