Phio Pharmaceuticals Announces Positive Safety Monitoring Committee (SMC) Recommendation to Continue to Third Dose Cohort in its Clinical Study of PH-762
Phio Pharmaceuticals (NASDAQ: PHIO) announced positive results from the second cohort of its Phase 1b clinical trial evaluating PH-762 for treating various skin cancers. The Safety Monitoring Committee (SMC) recommended proceeding to the third dose cohort following encouraging safety data. The second cohort, comprising 4 patients with cutaneous squamous cell carcinoma, showed promising results with the first two patients achieving complete response (100% tumor clearance) and partial response (90% clearance) at Day 36. The intratumoral injections were well-tolerated with no dose-limiting toxicities or serious adverse events reported.
Phio Pharmaceuticals (NASDAQ: PHIO) ha annunciato risultati positivi dalla seconda coorte del suo studio clinico di Fase 1b che valuta PH-762 per il trattamento di vari tumori cutanei. Il Comitato di Monitoraggio della Sicurezza (CMS) ha raccomandato di procedere alla terza coorte di dosaggio dopo dati di sicurezza incoraggianti. La seconda coorte, composta da 4 pazienti con carcinoma squamoso cutaneo, ha mostrato risultati promettenti con i primi due pazienti che hanno raggiunto una risposta completa (100% di eliminazione del tumore) e una risposta parziale (90% di eliminazione) al Giorno 36. Le iniezioni intratumorali sono state ben tollerate, senza tossicità limitanti la dose o eventi avversi gravi segnalati.
Phio Pharmaceuticals (NASDAQ: PHIO) anunció resultados positivos de la segunda cohorte de su ensayo clínico de Fase 1b que evalúa PH-762 para el tratamiento de varios tipos de cáncer de piel. El Comité de Monitoreo de Seguridad (CMS) recomendó proceder a la tercera cohorte de dosis después de datos de seguridad alentadores. La segunda cohorte, compuesta por 4 pacientes con carcinoma de células escamosas cutáneas, mostró resultados prometedores, con los dos primeros pacientes alcanzando una respuesta completa (100% de reducción del tumor) y una respuesta parcial (90% de reducción) el Día 36. Las inyecciones intratumorales fueron bien toleradas, sin toxicidades limitantes de dosis ni eventos adversos graves reportados.
Phio Pharmaceuticals (NASDAQ: PHIO)는 다양한 피부암 치료를 위한 PH-762의 1b상 임상 시험 두 번째 집단에서 긍정적인 결과를 발표했습니다. 안전성 모니터링 위원회(SMC)는 고무적인 안전성 데이터를 바탕으로 세 번째 투여 집단으로 진행할 것을 권장했습니다. 두 번째 집단은 피부 편평세포 carcinoma로 진단된 4명의 환자로 구성되어 있으며, 첫 두 환자가 36일째에 완전 반응 (종양 제거 100%)과 부분 반응 (90% 제거)을 보이는 유망한 결과를 나타냈습니다. 종양 내 주사는 잘 견디며, 용량 제한 독성이나 심각한 부작용은 보고되지 않았습니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a annoncé des résultats positifs de la seconde cohorte de son essai clinique de Phase 1b évaluant PH-762 pour le traitement de divers cancers de la peau. Le Comité de Surveillance de la Sécurité (CSS) a recommandé de passer à la troisième cohorte de dose suite à des données de sécurité encourageantes. La seconde cohorte, composée de 4 patients atteints de carcinome épidermoïde cutané, a montré des résultats prometteurs avec les deux premiers patients atteignant une réponse complète (100 % d'élimination de la tumeur) et une réponse partielle (90 % d'élimination) au Jour 36. Les injections intratumorales ont été bien tolérées, sans toxicités limitant la dose ni événements indésirables graves signalés.
Phio Pharmaceuticals (NASDAQ: PHIO) gab positive Ergebnisse aus der zweiten Kohorte seiner Phase-1b-Studie bekannt, die PH-762 zur Behandlung verschiedener Hautkrebserkrankungen bewertet. Der Sicherheitsüberwachungsausschuss (SMC) empfahl, zur dritten Dosis-Kohorte überzugehen, nachdem ermutigende Sicherheitsdaten vorlagen. Die zweite Kohorte, bestehend aus 4 Patienten mit kutanem Plattenepithelkarzinom, zeigte vielversprechende Ergebnisse, wobei die ersten beiden Patienten am Tag 36 eine komplette Antwort (100 % Tumorentfernung) und eine partielle Antwort (90 % Entfernung) erreichten. Die intratumoralen Injektionen wurden gut vertragen, ohne dass dosislimitierende Toxizitäten oder schwerwiegende unerwünschte Ereignisse gemeldet wurden.
- Complete response (100% tumor clearance) in first patient
- Partial response (90% clearance) in second patient
- No dose-limiting toxicities or serious adverse events reported
- SMC approval to proceed to third dose cohort
- Efficacy data pending for 2 out of 4 patients in second cohort
Insights
The positive SMC recommendation for PH-762's Phase 1b trial marks a important milestone in Phio's clinical development program. The safety profile demonstrated in the second cohort, coupled with preliminary efficacy data showing 100% tumor clearance in one patient and 90% clearance in another, suggests promising therapeutic potential. The absence of dose-limiting toxicities is particularly noteworthy for an RNA interference-based therapy.
INTASYL® technology's mechanism of action, which enhances immune cell effectiveness against cancer cells through siRNA gene silencing, represents an innovative approach in immuno-oncology. The progression to the third dose cohort indicates a well-controlled dose-escalation strategy, essential for establishing the optimal therapeutic window. For cutaneous malignancies, where local administration is feasible, this delivery method could minimize systemic exposure while maximizing therapeutic effect.
In simpler terms: Think of PH-762 as a precision tool that helps unmask cancer cells to the immune system. The fact that it's being injected directly into tumors and showing strong early results without major side effects is like successfully testing a new key that fits perfectly into a lock without damaging the surrounding area.
For a micro-cap biotech with a market cap of just
The focus on multiple skin cancers (cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma) provides diversification and expands the potential market opportunity. Early signs of complete and partial responses in the first two patients of the second cohort suggest meaningful clinical benefit, which could translate into commercial value if confirmed in larger studies.
For the average investor: This is like a small pharmaceutical company passing important safety tests for a new cancer treatment while also showing it might actually work well. It's still early, but these positive results could make the company more valuable and attractive to bigger pharmaceutical companies looking for new cancer treatments.
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 (
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
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. Examples of forward-looking statements contained in this press release include, among others, the possibility that our INTASYL® siRNA gene silencing technology will make the body's immune cells more effective in killing cancer cells and statements regarding our commercial and clinical strategy, development plans and timelines and other future events.
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.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/234425
FAQ
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