Phio Pharmaceuticals Announces Completion of Dosing in First Patient Cohort in PH-762 Phase 1b Dose-Escalation Study
Phio Pharmaceuticals has completed dosing the first patient cohort in its Phase 1b trial for PH-762, a lead product designed to enhance immune cell tumor-fighting capabilities using INTASYL™ siRNA gene silencing technology. The trial, conducted across multiple centers, aims to assess the safety, tolerability, and tumor response of intratumoral PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. Screening for the next dose cohort is ongoing. The study’s results will help determine the recommended dose for further research.
- Dosing completed for the first patient cohort in the Phase 1b study of PH-762.
- Screening for the next dose cohort is already underway.
- PH-762 aims to treat cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
- The trial will help determine the recommended dosage for future studies.
- Multi-center trial design enhances the reliability of the study results.
- No concrete efficacy data provided yet, presenting an uncertainty for investors.
- Completion of dosing in only the first patient cohort suggests the study is still in early stages, indicating longer timeframes for potential market approval.
- No information on any potential adverse effects or setbacks encountered.
Insights
Completion of the first patient cohort dosing in a Phase 1b study is a significant milestone for Phio Pharmaceuticals' lead compound, PH-762. This study targets cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma—all highly aggressive forms of skin cancer. While the primary goal of Phase 1b is to assess safety and tolerability, the secondary focus on tumor response and dose determination is important for future phases.
From a clinical perspective, the success of this stage could pave the way for more advanced trials, potentially transforming treatment options for patients with these types of skin cancer. However, the results of these early-stage trials must be taken cautiously. Past trends in oncology show that many promising Phase 1/1b candidates do not always translate into successful Phase 2 or 3 results.
For retail investors, while it's optimistic news, it's important to remember that this is just an early step in a long, regulated process. The immediate impact on the stock might be minimal, but successful ongoing results could significantly enhance the company's valuation and market potential in the long term.
Phio Pharmaceuticals' progress in their Phase 1b trial of PH-762 is a telling indicator of the company's innovative approach in the biotech sector. The use of siRNA gene silencing technology to enhance immune cell efficacy against tumors is an advanced and specialized treatment modality. For context, siRNA (small interfering RNA) works by disrupting the expression of specific genes that allow cancer cells to thrive, offering a potentially powerful therapeutic avenue.
The fact that the study is multi-center adds to its credibility, ensuring that data is collected from diverse populations and clinical settings, which can provide a more comprehensive safety profile and efficacy data. However, the current phase mainly focuses on safety and optimal dosing, which means significant efficacy results are still pending.
For investors, understanding that this milestone is part of a larger, multi-phase process is key. The potential of siRNA treatments can be revolutionary, but each stage of clinical trials carries its own risks and uncertainties. The successful completion of early-phase trials could lead to lucrative future partnerships or investments, yet the inherent risks in clinical trials should not be underestimated.
The completion of dosing in the first patient cohort for Phio Pharmaceuticals' PH-762 Phase 1b study represents a forward step in the company's product pipeline, which can have several financial implications. Firstly, achieving this milestone might signal to investors that the company is effectively managing its clinical development timelines, potentially leading to increased investor confidence and
However, it's essential to consider the burn rate associated with ongoing clinical trials. Biotechnology firms often have substantial operational costs and the successful progression through clinical phases usually requires significant capital. Investors should keep an eye on the company's cash reserves and any future funding rounds or partnerships that may be necessary to complete the clinical trial phases.
Long-term financial impact hinges on future trial results, regulatory approvals and market adoption rates. Early-stage positive news is promising, but prudent investors should balance this potential with the inherent risks of clinical development in the biotech space.
-PH-762 is Phio’s lead product candidate
-Screening on the next cohort is on-going
MARLBOROUGH, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced progress on its Phase 1b clinical study for their lead compound PH-762. Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.
Phio’s Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical 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 study will assess the tumor response, and determine the recommended dose for further study of PH-762.
“This is exciting news for Phio and our lead compound PH-762 with the dosing of the 1st cohort completed, we look forward to advancing the study to bring an innovative treatment option to patients with skin carcinomas,” said Robert Bitterman, CEO of Phio Pharmaceuticals.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells. INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems.
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. 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. Examples of forward-looking statements include statements regarding the potential of PH-762 to treat skin carcinomas. 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.
ir@phiopharma.com
PR Contact
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Bridge View Media
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