Latest news with #INTASYL®
Associated Press
07-05-2025
- Business
- Associated Press
Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial
Complete Pathologic Response reported in 2 patients in the Third Cohort with cutaneous squamous cell carcinoma, complementing results in prior cohort Phio to present trial results to date at a podium presentation at Society for Investigative Dermatology (SID) Annual Meeting on May 10th Marlborough, Massachusetts--(Newsfile Corp. - May 7, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® gene silencing technology to eliminate cancer. Phio announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort. The third patient was reported as having a pathologic non-response (<50% tumor clearance). 'These positive outcomes continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market,' said Robert Bitterman, President and CEO of Phio Pharmaceuticals. Phio's ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance). Patients with pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited clinical progression of disease. To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling patients; Phio expects to complete enrollment in the trial in the third quarter of 2025. 'The continued positive pathologic responses in this clinical trial of intratumoral PH-762 for cutaneous carcinoma increases our understanding of the potential therapeutic benefit for this immunotherapy. The safety profile supports ongoing dose escalation,' said Mary Spellman, MD, Phio's acting Chief Medical Officer. About Phio Pharmaceuticals Corp. Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company advancing its INTASYL ® gene silencing technology focused on immuno-oncology therapeutics. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The on-going Phase 1b clinical trial (NCT# 06014086) is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, 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, the potential for PH-762 to present a viable non-surgical alternative for skin cancer, expectations regarding timing of enrollment, 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: [email protected] To view the source version of this press release, please visit
Associated Press
09-04-2025
- Business
- Associated Press
Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Study to Fourth Dose Escalation Cohort
-Phio's lead clinical siRNA compound PH-762 demonstrates supportive safety profile in third cohort, permitting escalation in next dose concentration Marlborough, Massachusetts--(Newsfile Corp. - April 9, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio's Phase 1b clinical trial (NCT 06014086) for Phio's lead product candidate, PH-762. Phio's Phase 1b clinical trial is a multi-center, dose-escalating trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This trial assesses the tumor response and determines the recommended dose for further study of PH-762. In the third cohort of this trial, three patients with cutaneous squamous cell carcinoma were enrolled. For these patients, injections were well tolerated with no serious adverse events and there were no dose-limiting toxicities. Pathology results related to efficacy of PH-762 in the third cohort are forthcoming. 'We are impressed with the continuing safety profile of PH-762 having now progressed through the first 3 escalating doses,' said Mary Spellman, MD, Phio's acting Chief Medical Officer. Previously, seven patients diagnosed with cutaneous carcinomas were treated in dose cohorts 1 and 2. The second cohort enrolled a total of 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision) in the second cohort, two patients had a complete response (100% tumor clearance), and one patient had a partial response (90% clearance). All three patients in cohort 1 and one patient in cohort 2 maintained stable disease. 'We are optimistic that the clinical trial will continue to demonstrate that PH-762 may present a viable non-surgical alternative to existing modes of therapy for skin cancer,' said Robert Bitterman, President and CEO of Phio Pharmaceuticals. About Phio Pharmaceuticals Corp. Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company advancing its proprietary INTASYL ® siRNA gene silencing technology to eliminate cancer. Phio's INTASYL compounds are designed to enhance the body's immune cells to more effectively kill cancer cells. Phio's lead clinical program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The on-going Phase 1b trial (NCT# 06014086) is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers. For additional information, visit the Company's website, 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. Phio Pharmaceuticals Corp.
Associated Press
10-03-2025
- Business
- Associated Press
American Academy of Dermatology Awards Podium Presentation to Phio Pharmaceutical's Clinical Research at 2025 Annual Meeting
Interim Results from clinical study for cutaneous carcinomas presented at Late-Breaking Research Session Marlborough, Massachusetts--(Newsfile Corp. - March 10, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL ® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced that a podium presentation addressing its lead product candidate, PH-762, was given in the Academy's Late-Breaking Research session. The Late-Breaking Research session includes oral presentations of the top-scoring abstracts that address common and complex dermatological conditions. Mary Spellman, MD, FAAD, presented " PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: Interim Results from an Ongoing Study of INTASYL PH-762" which provided details on the design and progress of Phio's ongoing open-label Phase 1b clinical study (NCT 06014086), to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma. Stages 1 and 2 cSCC represent 77% of all new cSCC annually. Recent data showed that, of the four patients who have completed treatment in the second dose cohort, two patients with cutaneous squamous cell carcinoma achieved a complete response (100% pathological cure) while a third patient with squamous cell carcinoma achieved a partial response (90% pathological cure). The fourth patient in this cohort exhibited stable disease, having not progressed. The study recently fulfilled the required enrollment for safety in its third dose cohort. Initiation of screening of the fourth dose cohort is planned for early April. 'We are excited to share our progress in this trial with the dermatology community,' said Mary Spellman M.D., Phio's acting Chief Medical Officer. 'We believe that this immuno-oncology therapy may offer patients meaningful clinical benefit, while minimizing surgical interventions.' 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 to 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, 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. Phio Pharmaceuticals Corp.
Associated Press
20-02-2025
- Business
- Associated Press
Phio Pharmaceuticals Announces Appointment of David H. Deming to Board of Directors
Marlborough, Massachusetts--(Newsfile Corp. - February 20, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL ® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today the appointment of Mr. David H. Deming to the Phio Board of Directors, effective Feb 19, 2025. Mr. Deming will immediately serve as a member of the Board's Nominating Committee. Following the appointment of Mr. Deming, the Board now comprises 6 directors, 5 of whom are independent. 'Mr. Deming's extensive experience in in the biopharma sector, both through his investment banking career and service on a number of corporate boards provides a valuable resource to Phio as we pursue our mission to advance our gene silencing technology for a cancer free future.' said Robert Bitterman, CEO and Chairman of the Board. David Deming has over 30 years of experience in investment banking and asset management. He was with JP Morgan for over 27 years in both M&A and leading the Health Group in investment banking for his last 12 years there. After leaving JP Morgan, he joined Integrated Finance Limited where he developed the SmartNest 401(k) asset allocation product which was sold to Dimensional Fund Advisors in 2010. David graduated from Hobart College with a Bachelor of Arts degree in Economics. He served on the Hobart and William Smith Colleges Board of Trustees for 15 years, serving 9 years as Chairman. 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, 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. Phio Pharmaceuticals Corp.
