A Breakthrough in Skin Cancer Treatment: PH-762's Promising Clinical Results
Unveiling the Success of PH-762 in Clinical Trials
Phio Pharmaceuticals, a biotechnology firm with a market capitalization of $9 million, witnessed a substantial increase in its stock value on Tuesday. This surge followed the announcement of favorable outcomes from its Phase 1b clinical trial of PH-762, a leading candidate drug. The trading volume for the session reached an impressive 5.82 million, a stark contrast to the average of 412.49 thousand, as reported by Benzinga Pro data.
Ensuring Patient Safety: The Committee's Positive Findings
The Safety Monitoring Committee recently concluded its review of the trial, providing a positive assessment. Their findings indicated a complete absence of serious adverse events or dose-limiting toxicities across all five cohorts involved in the dose escalation study. This robust safety profile is a crucial factor in the continued development of PH-762.
Remarkable Efficacy: Tumor Clearance at Highest Dosage
A particularly noteworthy aspect of the trial results was the efficacy observed at the highest dose concentration. This cohort achieved an 85% pathological response rate, with four out of six patients experiencing complete tumor clearance. This demonstrates the significant potential of PH-762 in combating cutaneous carcinomas, a form of skin cancer.
Comprehensive Patient Evaluation and Treatment Regimen
A total of 22 patients suffering from cutaneous carcinomas successfully completed the treatment phase of the Phase 1b trial. These patients underwent the excision of the treated lesion site after receiving four intratumoral injections of PH-762. Each patient was then meticulously monitored for at least four weeks post-final injection. The drug was administered across five escalating dose cohorts, with a twenty-fold increase in concentration from the first to the final cohort.
Anticipated Milestones: FDA Submission and Manufacturing Plans
While the comprehensive data from the study is still undergoing formal analysis, Phio Pharmaceuticals is targeting the second quarter of 2026 for an FDA submission. This submission aims to propose and seek guidance for the subsequent stages of clinical study design for PH-762. Furthermore, the company is on schedule with experimental work and documentation for process and methods development, including impurity testing, to initiate the manufacturing of cGMP material in the latter half of 2026.
Preparing for Pivotal Trials: Non-Human Primate Studies
In preparation for human pivotal trials, Phio Pharmaceuticals is poised to have material ready for non-human primate studies by March 2026. This is a critical prerequisite for advancing the drug to the next phase of human testing. These ongoing developments highlight PH-762's potential to offer a groundbreaking non-surgical treatment option for skin cancers.
Market Performance and Technical Indicators of Phio Pharmaceuticals
Currently, Phio Pharmaceuticals' stock is trading 12.5% below its 20-day simple moving average and 17.3% below its 50-day simple moving average, suggesting a bearish trend in the short to medium term. Over the last year, the shares have seen a decrease of approximately 49.44%, positioning the stock closer to its 52-week lows, which indicates ongoing market challenges. The Relative Strength Index (RSI) stands at 34.74, placing it in a neutral zone, while the Moving Average Convergence Divergence (MACD) is below its signal line, signaling bearish pressure. This combination of a neutral RSI and bearish MACD points to mixed momentum for the stock.
Key Support and Resistance Levels, and Recent Price Action
For investors, the key resistance level for PHIO is identified at $1.00, with a key support level at 81 cents. On Tuesday, at the time of publication, Phio Pharma shares experienced a significant increase of 51.11%, reaching $1.36, according to Benzinga Pro data.