VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM) today announced that the UK's Healthcare Products Regulatory Agency (MHRA) has granted a waiver for the pediatric study of its investigational cancer treatment, Multikine, for head and neck cancer. This waiver means that CEL-SCI will not need to conduct trials of Multikine in patients under 18 as part of its marketing approval process in the UK.
The company's CEO, Geert Kersten, expressed satisfaction with the MHRA's decision, noting that it represents a step forward in bringing Multikine to the UK market. CEL-SCI is gearing up to begin a confirmatory FDA Registration Study of Multikine in the United States and other locations.
Multikine (Leukocyte Interleukin, Injection) is being developed as a first-line therapy for cancer and has been administered to over 740 patients. The treatment has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. According to CEL-SCI, Multikine demonstrated a significant increase in survival rates in its target patient population during clinical trials, with a 73% survival rate at five years post-treatment compared to 45% for those who did not receive it. These results have led the FDA to agree to the company's patient selection criteria for a forthcoming Registration Study, which will enroll 212 patients.
CEL-SCI operates out of Vienna, Virginia, with additional facilities near Baltimore, Maryland. The company emphasizes the importance of enhancing a patient's immune system early in cancer treatment for the best chance of survival.
The press release includes forward-looking statements, which involve risks and uncertainties that could cause actual results to differ materially from those projected. CEL-SCI cautions that it cannot guarantee the ability to replicate clinical results or obtain necessary regulatory approvals, and it faces challenges such as manufacturing difficulties and capital raising. The company's filings with the Securities and Exchange Commission detail these and other risk factors.
The information in this article is based on a press release statement from CEL-SCI Corporation. Multikine has not yet been licensed or approved for sale by the FDA or any other regulatory agency, and its safety and efficacy for any use have not been established.
In other recent news, CEL-SCI Corporation announced a public offering of 10,845,000 shares, priced at $1.00 each, with projected gross proceeds of $10.8 million before fees and expenses. The funds are set to be used for the development of Multikine, the company's leading investigational therapy, as well as for general corporate needs and working capital. Furthermore, the company reported positive outcomes from a comprehensive bias analysis for its Phase 3 study of Multikine, a potential immunotherapy for head and neck cancer.
The analysis found no significant differences between the treatment and control groups, supporting Multikine's clinical effect in extending patient survival. In line with these developments, the FDA has approved CEL-SCI for a confirmatory Registration Study of Multikine. The study will focus on newly diagnosed patients with no lymph node involvement and low PD-L1 tumor expression, a group that showed a significant survival benefit in the Phase 3 study.
These are recent developments in the company's progress in the field of cancer immunotherapy. However, it is crucial to note that Multikine is still under investigation and has not yet been approved by the FDA or any other regulatory agency. The safety and efficacy of Multikine have not yet been established for any use.
InvestingPro Insights
As CEL-SCI Corporation (NYSE American: CVM) advances with its investigational cancer treatment, Multikine, investors are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, CEL-SCI's gross profit for the last twelve months as of Q3 2024 stands at a negative $18.95 million, indicating challenges in generating profit from its operations. The company's operating income, adjusted for the same period, also reflects a deficit of $27.7 million.
The market has responded to these financial metrics, with CEL-SCI's stock experiencing a significant downturn. Over the last six months, the price total return has plummeted by 53.25%, emphasizing the volatility and the high-risk nature of investing in this biotech firm at its current stage.
InvestingPro Tips suggest that CEL-SCI suffers from weak gross profit margins and analysts do not anticipate the company will be profitable this year. Additionally, the company has not been profitable over the last twelve months. These insights, coupled with the company's current financial data, can help investors make more informed decisions. For those looking for a deeper dive into CEL-SCI's financials and future prospects, more InvestingPro Tips are available, providing a comprehensive analysis of the company's performance and outlook.
Investors interested in CEL-SCI's detailed financial analysis and additional InvestingPro Tips can find them at: https://www.investing.com/pro/CVM, where a total of 8 tips are listed to further guide investment decisions.
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