Phio Pharmaceuticals Announces Completion of Enrollment in Second Cohort in Phase 1b Dose-Escalating Clinical Study
Phio Pharmaceuticals (NASDAQ: PHIO) has completed enrollment for the second cohort in its PH-762 Phase 1b dose-escalating clinical trial and added a sixth clinical site in San Diego. New data from the trial shows promising results, with one patient achieving complete response (100% tumor clearance) and another achieving partial response (90% tumor clearance) in the second dose cohort. The study evaluates PH-762, an INTASYL compound that silences PD-1, in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma.
Phio Pharmaceuticals (NASDAQ: PHIO) ha completato l'arruolamento per la seconda coorte del suo trial clinico di fase 1b, dose escalante PH-762, e ha aggiunto un sesto sito clinico a San Diego. I nuovi dati dello studio mostrano risultati promettenti, con un paziente che ha raggiunto una risposta completa (clearance tumorale del 100%) e un altro che ha raggiunto una risposta parziale (clearance tumorale del 90%) nella seconda coorte di dosaggio. Lo studio valuta PH-762, un composto INTASYL che silenzia PD-1, in pazienti con carcinoma a cellule squamose cutanee, melanoma o carcinoma a cellule di Merkel.
Phio Pharmaceuticals (NASDAQ: PHIO) ha completado la inscripción para la segunda cohorte en su ensayo clínico de fase 1b con dosis escalonadas, PH-762, y ha añadido un sexto sitio clínico en San Diego. Nuevos datos del ensayo muestran resultados prometedores, con un paciente que logró una respuesta completa (100% de eliminación del tumor) y otro que obtuvo una respuesta parcial (90% de eliminación del tumor) en la segunda cohorte de dosis. El estudio evalúa PH-762, un compuesto INTASYL que silencia PD-1, en pacientes con carcinoma de células escamosas cutáneas, melanoma o carcinoma de células de Merkel.
Phio Pharmaceuticals (NASDAQ: PHIO)는 PH-762 1b상 시험의 두 번째 코호트를 위한 등록을 완료하고 샌디에고에 여섯 번째 임상 사이트를 추가했습니다. 시험의 새로운 데이터는 유망한 결과를 보여주며, 한 환자는 완전 반응 (100% 종양 제거)을 달성했고, 다른 환자는 두 번째 용량 코호트에서 부분 반응 (90% 종양 제거)을 달성했습니다. 이 연구는 피부 편평 세포 암, 흑색종 또는 메르켈 세포 암 환자에서 PD-1을 침묵시키는 INTASYL 화합물인 PH-762를 평가합니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a complété l'inscription pour la deuxième cohorte de son essai clinique de phase 1b sur l'escalade des doses PH-762 et a ajouté un sixième site clinique à San Diego. De nouvelles données de l'essai montrent des résultats prometteurs, avec un patient atteignant une réponse complète (élimination tumorale à 100 %) et un autre un réponse partielle (élimination tumorale à 90 %) dans la deuxième cohorte de dosage. L'étude évalue PH-762, un composé INTASYL qui silencie PD-1, chez des patients atteints de carcinome squameux cutané, de mélanome ou de carcinome à cellules de Merkel.
Phio Pharmaceuticals (NASDAQ: PHIO) hat die Rekrutierung für die zweite Kohorte in seiner PH-762 Phase 1b Dosissteigerungsstudie abgeschlossen und einen sechsten klinischen Standort in San Diego hinzugefügt. Neue Daten aus der Studie zeigen vielversprechende Ergebnisse, wobei ein Patient eine vollständige Remission (100% Tumorentfernung) und ein anderer eine partielle Remission (90% Tumorentfernung) in der zweiten Dosis-Kohorte erreicht hat. Die Studie bewertet PH-762, eine INTASYL-Verbindung, die PD-1 zum Schweigen bringt, bei Patienten mit kutanem Plattenepithelkarzinom, Melanom oder Merkelzellkarzinom.
- Complete response (100% tumor clearance) achieved in one patient
- Partial response (90% tumor clearance) achieved in second patient
- Expansion of clinical trial sites to six locations across the U.S.
- None.
Insights
The completion of enrollment in the second cohort of PH-762's Phase 1b trial represents meaningful clinical progress, particularly given the impressive early efficacy signals. The complete response (100% tumor clearance) in one patient and partial response (90% tumor clearance) in another patient with squamous cell carcinoma are encouraging preliminary results that warrant attention.
PH-762's mechanism of action targeting PD-1 through INTASYL technology is particularly interesting in the context of skin cancers. The expansion to six clinical trial sites across the U.S. suggests strong investigator interest and could accelerate future enrollment. However, investors should note that these are early-stage results from a small patient population and the primary endpoints focus on safety and tolerability rather than efficacy.
--Six sites across the U.S. are now engaged in Phase1b study
Marlborough, Massachusetts--(Newsfile Corp. - November 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company exploring new pathways towards a cancer-free future, today announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San Diego, CA.
Phio recently presented new data from the ongoing clinical trial showing that, of the two patients who have completed treatment in the second dose cohort, one patient with cutaneous squamous cell carcinoma achieved a complete response (
The new clinical trial site, Paradigm Clinical Research Centers in San Diego, CA joins five other sites across the country:
- Banner MD Anderson Cancer Center in Gilbert, Arizona
- The George Washington University-Medical Faculty Associates in Washington, D.C.
- The University of Pittsburgh Medical Center (UPMC)-Department of Dermatology, Pittsburgh, PA
- Integrity Research Clinical Associates in Delray Beach, Florida
- Centricity Research in Dublin, Ohio
"We are pleased with enrollment completion of the second dose cohort and the encouraging patient outcomes in the first two patients in this cohort," said Robert Bitterman, CEO of Phio Pharmaceuticals.
Phio develops therapeutics that use its proprietary INTASYL® siRNA gene silencing technology designed to make immune cells more effective in killing cancer cells. 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 dose escalation study for our lead product candidate, 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.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company and a pioneer in the RNAi revolution advancing its proprietary INTASYL™ siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually any gene with a 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 is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for specialized formulations or drug delivery systems.
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:
Jennifer Phillips
VP Regulatory and Corporate Affairs
Phio Pharmaceuticals Corp.
jphillips@phiopharma.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/230408
FAQ
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