CEL-SCI | MedPath

CEL-SCI Secures $5 Million in Public Offering to Advance Multikine Immunotherapy for Head and Neck Cancer

2 days ago

• CEL-SCI Corporation has raised $5 million through a public offering of 2 million shares at $2.50 per share to fund the continued development of its cancer immunotherapy Multikine. • The company's Multikine therapy, designed to boost patients' immune systems before conventional treatments, has received FDA approval for a confirmatory Registration Study following promising Phase 3 results. • The upcoming study will enroll 212 newly diagnosed head and neck cancer patients with specific characteristics, targeting a population of approximately 100,000 patients annually.

CEL-SCI Advances Multikine for Head and Neck Cancer with FDA-Cleared 212-Patient Registration Study

3 months ago

• CEL-SCI received FDA clearance for a 212-patient confirmatory registration study of Multikine in squamous cell head and neck cancer patients with specific biomarker criteria. • Previous IT-MATTERS study demonstrated significant survival benefit, with 73% survival in Multikine-treated patients versus 45% in control group at five years. • The company has appointed Ergomed as CRO for the global trial starting Q1 2025, secured $5 million in funding, and estimates trial costs at $30 million.

CEL-SCI's Multikine Demonstrates Promising Tumor Regression, Advances to Confirmatory Phase 3 Trial for Head and Neck Cancer

4 months ago

• CEL-SCI's Multikine showed significant pre-surgical tumor regression in head and neck cancer patients within three weeks, a finding confirmed by pathology. • The FDA has approved CEL-SCI's plan to use PD-L1 as a biomarker for patient selection in the confirmatory Phase 3 trial, focusing on patients with low PD-L1 expression. • A confirmatory 212-patient Registration Study is set to commence, designed to confirm efficacy and safety results from a previous Phase 3 trial, with full enrollment expected by Q2 2026. • Multikine demonstrated a 73% 5-year survival rate in patients with low PD-L1 expression, compared to 45% in the control group, indicating a potential new standard of care.

Bioxodes Advances BIOX-101 for Intracerebral Hemorrhage Treatment with New Funding and Clinical Milestones

5 months ago

• Bioxodes secured €2.7 million in Series A extension funding to advance BIOX-101, a novel therapy for intracerebral hemorrhage (ICH). • The funding supports the completion of the BIRCH Phase 2a trial and preparations for a Phase 2b trial of BIOX-101 in ICH. • Interim data from the BIRCH Phase 2a trial, evaluating BIOX-101 in ICH patients, is expected in Q1 2025. • BIOX-101, derived from tick saliva, aims to reduce secondary brain injuries post-hemorrhagic stroke by preventing clot formation and neuroinflammation.

Innocan Pharma's LPT-CBD Shows Promise in Chronic Pain Treatment, Advances Towards FDA Approval

5 months ago

• Innocan Pharma's LPT-CBD demonstrated high bioavailability and long-lasting pain relief in preclinical animal models, supporting its potential as a chronic pain treatment. • The FDA has agreed to Innocan's preclinical and Phase 1 clinical development plan for LPT-CBD, utilizing the 505(b)(2) regulatory pathway for accelerated commercialization. • Studies in animals, including dogs with osteoarthritis, showed that LPT-CBD injections led to noticeable pain reduction and improved mobility, even after NSAIDs failed. • Innocan received an Investigational New Animal Drug (INAD) designation from the FDA's Center for Veterinary Medicine, facilitating LPT-CBD's development as a veterinary drug.

CEL-SCI's Multikine Receives FDA Approval for Confirmatory Head and Neck Cancer Study

5 months ago

• CEL-SCI's Multikine has received FDA approval for a confirmatory registration study involving 212 patients with head and neck cancer. • The study will focus on patients who demonstrated a 73% survival rate with Multikine, compared to 45% in control groups, in a prior Phase 3 trial. • The trial targets newly diagnosed, locally advanced head and neck cancer patients without lymph node involvement and low PD-L1 tumor expression. • Multikine previously showed significant tumor regression within three weeks of pre-surgical therapy, including five complete regressions in Phase 3.

CEL-SCI's Cancer Drug Shows 73% Survival Rate, FDA Agrees on PD-L1 Biomarker Use

7 months ago

CEL-SCI Corporation has announced a 73% survival rate in patients with low PD-L1 expression treated with Multikine, following an agreement with the FDA on using PD-L1 as a biomarker for patient selection in a confirmatory Registration Study set to begin in Q1 2025.

CEL-SCI Partners with Ergomed for Multikine Confirmatory FDA Registration Study in Head and Neck Cancer

8 months ago

• CEL-SCI has partnered with Ergomed for a confirmatory FDA registration study of Multikine in head and neck cancer, building on prior successful collaborations. • The study will enroll 212 patients with locally advanced primary head and neck cancer, focusing on those with no lymph node involvement and low PD-L1 expression. • Previous studies showed Multikine improved 5-year survival rates to 73% compared to 45% in the control group for the target population. • The confirmatory study is set to commence in Q1 2025 across multiple countries, marking a crucial step toward potential marketing approval.

CEL-SCI Receives FDA Approval for Confirmatory Study of Multikine in Head and Neck Cancer Treatment

a year ago

CEL-SCI Corporation has received FDA approval to proceed with a confirmatory study of its cancer immunotherapy, Multikine, for newly diagnosed advanced primary head and neck cancer patients. The study, based on strong safety and efficacy data from a completed Phase 3 study, aims to confirm the survival benefits observed in the target patient population.