VIENNA, Va. – CEL-SCI Corporation (NYSE American: CVM) announced the results of a comprehensive bias analysis of the Phase 3 study of Multikine, an investigational immunotherapy for head and neck cancer, showing promising results. The analysis aimed to assess potential sources of bias to ensure the reliability and validity of the trial results.
The study included 923 patients with newly diagnosed, locally advanced, resectable primary head and neck cancer. Bias analysis showed no significant differences in demographic or baseline characteristics between the treatment and control groups, indicating no bias toward multikine. The results were considered statistically significant and support the clinical efficacy of multikine in prolonging patient survival.
CEL-SCI CEO Geert Kersten expressed confidence in the data, which suggests a five-year survival rate of 73% for patients treated with Multikine, compared to 45% for the control group. The company is preparing to submit the data to regulatory agencies, including the FDA, for a confirmatory registration study.
The upcoming study, under agreement with the FDA, will recruit 212 patients who meet specific criteria: newly diagnosed locally advanced primary head and neck cancer, no lymph node metastases, and low PD-L1 tumor expression. These criteria are consistent with the population that showed a notable survival benefit in the phase 3 study.
Multicaine has been administered to over 750 patients and has received orphan drug designation from the FDA for use as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
Headquartered in Vienna, Virginia, with operations near Baltimore, Maryland, the company focuses on improving patient survival by boosting the immune system before it is weakened by disease or treatment.
The information in this article is based on a press release statement from CEL-SCI Corporation. Multikine is still under investigation and has not been approved for sale by the FDA or any other regulatory agency.
Safety and efficacy have not yet been established for any use. Forward-looking statements in press releases are subject to various risks and uncertainties that could affect the company’s actual results.
InvestingPro Insights
CEL-SCI Corporation (NYSE American: CVM) shared positive results from the Phase 3 study of Multikine, but it is important for investors to also consider the company’s financial health and market performance. Here are some key insights based on recent data from InvestingPro:
InvestingPro Data:
- Gross Margin (Last 12 Months as of Q2 2024): -$19.98M
- Operating Income, Adjusted (Last 12 Months as of Q2 2024): -$29.21M
- 6-month price total return (as of mid-2024): -57.99%
The figures suggest that while MultiKine’s clinical development is progressing, the company is facing financial difficulties, with both gross and operating income declining significantly over the past 12 months. The stock price has also fallen significantly over the past six months, which may reflect investor concerns about the company’s profitability and future.
InvestingPro Tips:
1. CEL-SCI’s stock price took a significant hit last week with a return of -8.33%, which may be concerning for current and potential investors.
2. Analysts contributing to InvestingPro expressed concern about the company’s weak gross margins and expected net income to decline this year.
For investors interested in a more in-depth analysis, here is an additional InvestingPro tip that provides comprehensive information on CEL-SCI’s financials, market performance, and potential risks. To learn more about these insights, visit https://www.investing.com/pro/CVM and consider applying the coupon code. Pro News 24 Get up to 10% off annual Pro subscriptions and 1-year or 2-year Pro+ subscriptions.
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