CEL-SCI Corporation - CVM STOCK NEWS

CEL-SCI (NYSE American: CVM) reported positive results from a bias analysis for its Phase 3 study of Multikine in head and neck cancer treatment. The analysis showed no bias in the study, with comparable demographics and baseline characteristics between Multikine-treated and control arms. This supports the reliability of the study data, which demonstrated Multikine's efficacy in extending patient life.

Key findings include:

• 5-year survival rate of 73% in Multikine-treated patients vs. 45% in control group for the target population
• Hazard ratio of 0.35 with an upper limit of 0.66, suggesting a high chance of repeating the survival benefit
• No confounding baseline parameters detected

CEL-SCI is preparing to submit data to regulators for a 212-patient confirmatory registration study, agreed upon with the FDA.

CEL-SCI (NYSE American: CVM) has appointed Robert Watson as Chairperson of the Board. Watson, who joined the board in 2017, has an extensive background in the healthcare sector, particularly in capital formation and partnerships. He has facilitated over $750 million in transactions throughout his career.

Watson's appointment comes at a pivotal moment for CEL-SCI, as the company prepares for a confirmatory Registration Study for its immunotherapy drug, Multikine. The FDA approved this study based on positive efficacy and safety data from over 750 patients. Multikine showed a 73% survival rate compared to 45% in the control group at five years post-treatment.

The forthcoming study will enroll 212 patients with advanced primary head and neck cancer, a condition impacting an estimated 100,000 patients annually. Watson expressed confidence in confirming the drug’s efficacy and safety, emphasizing his commitment to CEL-SCI’s mission.

CEL-SCI announced promising data for its investigational drug Multikine at the IDDST Annual Congress in Budapest. Dr. Eyal Talor presented findings showing that Multikine significantly improves overall survival in head and neck cancer patients with low PD-L1 expression levels. Specifically, the 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control group. The hazard ratio was 0.35, indicating a 5-year death risk reduction from 55% to 27%. The company is planning a confirmatory FDA registration study.

CEL-SCI announced that Dr. Giovanni Selvaggi, a renowned oncology expert, has joined as a Clinical Advisor. Dr. Selvaggi has been pivotal in the approval of lung cancer drugs such as Zykadia and Opdivo. CEL-SCI's Multikine immunotherapy has shown significant efficacy in head and neck cancer, improving 5-year survival to 73% compared to 45% in controls. The FDA has approved a confirmatory Registration Study for Multikine. Dr. Selvaggi will support CEL-SCI in navigating this trial, aiming for regulatory approval.

CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.

Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.

CEL-SCI has received FDA approval for a confirmatory study of its cancer immunotherapy Multikine for head and neck cancer patients, based on strong Phase 3 data showing a 73% survival rate with Multikine. The study will enroll 212 patients and aims to confirm the results of the Phase 3 trial, paving the way for potential approval. The FDA acknowledged the unmet need for improved therapies in this patient population, supporting approval for Multikine.

CEL-SCI (NYSE American: CVM) appoints Mario Gobbo, a seasoned expert in healthcare and energy finance, to its Board of Directors. With extensive experience in venture capital, private equity, and investment banking, Mr. Gobbo's addition brings valuable insights to the company's strategic growth. His background in successful healthcare ventures and strong industry connections positions CEL-SCI for advancements in medical breakthroughs, particularly in head and neck cancer treatment with the Multikine product.

CEL-4000, a potential therapy for rheumatoid arthritis (RA), aims to rebalance the inflammatory response without compromising immune defense mechanisms. The article discusses the benefits of CEL-4000 compared to current RA treatments, emphasizing its potential to provide safe and effective therapy for RA patients.

CEL-SCI Corporation (CVM) issues a letter to shareholders detailing successful advancements in the Multikine cancer therapy, presenting promising results from the Phase 3 trial. The company identified a target population for Multikine with significant survival benefits and presented key findings at a major oncology conference. The target population consists of newly diagnosed squamous cell carcinoma of the head and neck patients with specific characteristics, making them ideal candidates for Multikine treatment.