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Phio Pharmaceuticals Announces Positive Safety Monitoring Committee (SMC) Recommendation to Continue to Third Dose Cohort in its Clinical Study of PH-762
Newsfile Corp.
Newsfile Corp
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 (100% tumor clearance and a partial response 90% clearance), respectively. Pathology data assessing efficacy data on the remaining 2 patients is forthcoming.
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."
tw0122
2 años hace
MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification
FEBRUARY 10, 2023 biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company's Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma. The trial is ongoing at the Gustave Roussy Institute (Villejuif, France), one of the largest cancer centers in Europe. PH-762 is an INTASYL compound that reduces the expression of cell death Protein 1 (PD-1), a protein that inhibits T cells' ability to kill cancer cells. Decreasing the expression of PD-1 increases the capacity of T cells to kill cancer cells.
Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.
"We are pleased with the recommendation of the DMC as a reflection of the favorable safety and tolerability profile of PH-762 to date, and will continue to obtain additional safety data as well as evidence of pharmacologic effect as we develop PH-762 for advanced cutaneous tumors," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman.
In addition to the Phase 1b study in France, Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, early in the 2nd half of 2023.
About the Phase 1b Trial in Advanced Melanoma
The Phase 1b trial is an open-label, dose escalation trial that is expected to enroll up to 21 patients with advanced melanoma. PH-762 will be administered as a neoadjuvant monotherapy intratumorally once a week, for a total of four injections, across five dose levels which are normalized to tumor volume. Dosing will be followed by tumoral excision after an additional two weeks. The primary study objectives are: to evaluate the safety and tolerability, and pharmacokinetics of PH-762; to determine the potential immunologic and pathologic tumor responses; and to determine the recommended dose for later clinical studies. Tumor changes will be evaluated per RECIST criteria, adapted for use with intratumoral therapy, and by pathological response.
About INTASYL
INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. 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. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.
In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient. INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.
Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification
FEBRUARY 10, 2023
trendzone
2 años hace
Article on PHIO today
What Makes Phio Pharmaceuticals Corp. (PHIO) a New Buy Stock
Zacks Equity Research
Tue, October 25, 2022 at 12:00 PM·
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Phio Pharmaceuticals Corp. (PHIO) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.
A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.
Individual investors often find it hard to make decisions based on rating upgrades by Wall Street analysts, since these are mostly driven by subjective factors that are hard to see and measure in real time. In these situations, the Zacks rating system comes in handy because of the power of a changing earnings picture in determining near-term stock price movements.
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As such, the Zacks rating upgrade for Phio Pharmaceuticals Corp. is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price.
Most Powerful Force Impacting Stock Prices
The change in a company's future earnings potential, as reflected in earnings estimate revisions, and the near-term price movement of its stock are proven to be strongly correlated. The influence of institutional investors has a partial contribution to this relationship, as these big professionals use earnings and earnings estimates to calculate the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their transaction of large amounts of shares then leads to price movement for the stock.
For Phio Pharmaceuticals Corp. rising earnings estimates and the consequent rating upgrade fundamentally mean an improvement in the company's underlying business. And investors' appreciation of this improving business trend should push the stock higher.
Harnessing the Power of Earnings Estimate Revisions
Empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, so it could be truly rewarding if such revisions are tracked for making an investment decision. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions.
The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>>.
Earnings Estimate Revisions for Phio Pharmaceuticals Corp.
For the fiscal year ending December 2022, this company is expected to earn $1.28 per share, which is a change of 223.1% from the year-ago reported number.
Analysts have been steadily raising their estimates for Phio Pharmaceuticals Corp. Over the past three months, the Zacks Consensus Estimate for the company has increased 43.8%.
Bottom Line
Unlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of 'buy' and 'sell' ratings for its entire universe of more than 4000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a 'Strong Buy' rating and the next 15% get a 'Buy' rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term.
You can learn more about the Zacks Rank here >>>
The upgrade of Phio Pharmaceuticals Corp. to a Zacks Rank #2 positions it in the top 20% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term.
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Phio Pharmaceuticals Corp. (PHIO) : Free Stock Analysis Report
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