Drugs / Leukocyte Interleukin
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03038828 | Apr 2015 → Jun 2018 | anogenital human papillomavirus infection | CEL-SCI Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02115919 | Apr 2014 → Jan 2016 | anogenital human papillomavirus infection | United States Naval Medical Center, San Diego | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 51
| Date | Issuer | Release |
|---|---|---|
| 2026-08-04 | CEL-SCI Corporation | Results CEL-SCI Study Published in Peer-Reviewed Oral Oncology Supports Multikine's Biomarker Strategy and Potential Overall Survival Benefit Ahead of Head and Neck Cancer Confirmatory Registration Study cel-sci.com ↗ |
| 2026-07-30 | CEL-SCI Corporation | Results Leading Oncology Journal Accepts For Publication New CEL-SCI Multikine Phase 3 Data Demonstrating Overall Survival Benefit in Underserved Head and Neck Cancer Patients cel-sci.com ↗
Leading Oncology Journal Accepts For Publication New CEL-SCI Multikine Phase 3 Data Demonstrating Overall Survival Benefit in Underserved Head and Neck Cancer Patients |
| 2025-08-13 | CEL-SCI Corporation | Regulatory CEL-SCI's Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia: Allows for Patient Access and Reimbursement/Sale Upon Granting of the Designation Which Takes Approximately 60 Days Based on SFDA Timeline cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) today announced that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies. |
| 2025-04-08 | CEL-SCI Corporation | Results New Study in the Scientific Journal "Cancer Cell" Supports CEL-SCI's Strategy to Seek Early Approval for Multikine in Head and Neck Cancer Based on Pre-Surgical Tumor Responses cel-sci.com ↗
Head and neck cancer patients treated with Multikine who had complete or partial tumor responses before surgery had improvements in overall survival, suggesting pre-surgical tumor response is a strong indicator of efficacy and leads to improved overall survival |
| 2025-03-24 | CEL-SCI Corporation | Results CEL-SCI Reports New Data: Treatment with Multikine Resulted in up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients cel-sci.com ↗
Treatment with Multikine Resulted in up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients |
| 2025-03-17 | CEL-SCI Corporation | Regulatory CEL-SCI's Head and Neck Cancer Registration Study Protocol Clears FDA Review-in Talks with Potential Partners Interested in Commercialization of Multikine cel-sci.com ↗
The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024. |
| 2025-02-18 | CEL-SCI Corporation | Results CEL-SCI Reports Fiscal Q1 2025 Financial Results: Multikine Shows Pre-Surgical Tumor Elimination and Regression in Just 3 Weeks cel-sci.com ↗
These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. |
| 2024-11-07 | CEL-SCI Corporation | Regulatory U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025 cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. |
| 2024-09-16 | CEL-SCI Corporation | Results CEL-SCI's Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation cel-sci.com ↗
CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation |
| 2024-09-04 | CEL-SCI Corporation | Regulatory The UK's Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance cel-sci.com ↗
The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance |
| 2024-07-26 | CEL-SCI Corporation | Results CEL-SCI's Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of head and neck cancer. |
| 2024-06-18 | CEL-SCI Corporation | Results CEL-SCI Presents Head & Neck Cancer Data at Iddst Annual Congress in Budapest: Risk of Death Cut in Half for Patients Treated With Multikine in the Target Population cel-sci.com ↗
Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors |
| 2024-05-08 | CEL-SCI Corporation | Regulatory CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer cel-sci.com ↗
CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer |
| 2024-01-31 | CEL-SCI Corporation | Regulatory European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine® cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). |
| 2023-10-24 | CEL-SCI Corporation | Results CEL-SCI Releases Video Detailing Recent Phase 3 Findings & its Plans to Seek Immediate Regulatory Approvals cel-sci.com ↗
Mr. Kersten carefully explains how it is that patients in the target group who were treated with Multikine had a 5-year survival rate of 73% as compared to only 45% for those who did not receive Multikine, cutting the risk of death by half. |
| 2023-10-23 | CEL-SCI Corporation | Results 5-Year Head & Neck Cancer Survival Increased From 45% to 73% in CEL-SCI's Target Population, Cutting Risk of Death in Half, as Presented at Leading Cancer Conference ESMO 2023 cel-sci.com ↗
5-Year Head & Neck Cancer Survival Increased From 45% to 73% in CEL-SCI’s Target Population, Cutting Risk of Death in Half, as Presented at Leading Cancer Conference ESMO 2023 |
| 2023-10-05 | CEL-SCI Corporation | Regulatory CEL-SCI Files Request With the UK's MHRA Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer. |
| 2023-09-26 | CEL-SCI Corporation | Regulatory CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer cel-sci.com ↗
CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer |
| 2023-07-11 | CEL-SCI Corporation | Results CEL-SCI Reports Phase 3 Tumor PD-L1 Biomarker Data Demonstrate Multikine's Increased Efficacy and Points to Potential for Combination With Checkpoint Inhibitors for Head & Neck Cancer cel-sci.com ↗
Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors which most often show longer survival in a proportion of patients with a higher level of tumor cell PD-L1 expression |
| 2023-05-15 | CEL-SCI Corporation | Results Histopathology and Tumor Biomarker Analysis Confirm CEL-SCI's Multikine Significantly Prolonged Overall Survival in Head & Neck Cancer-Phase 3 Data Presented at ESTRO 2023 cel-sci.com ↗
Histopathology analysis confirmed improved 5-year survival in Multikine-treated subjects, showed improved progression free survival and improved local regional control, and significantly lowered death rate compared to control subjects who received standard of care alone |
| 2023-03-08 | CEL-SCI Corporation | Results CEL-SCI's Multikine Phase 3 Cancer Study Shows 43% Survival Extension cel-sci.com ↗ |
| 2022-10-17 | CEL-SCI Corporation | Results CEL-SCI'S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment cel-sci.com ↗
CEL-SCI’S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment |
| 2022-09-12 | CEL-SCI Corporation | Results CEL-SCI'S Phase 3 Data Presented at ESMO 2022: Neoadjuvant Multikine Achieved Groundbreaking Tumor Response & Extended Overall Survival in Locally Advanced Head and Neck Cancer cel-sci.com ↗
Early response was noted only in the Multikine* (Leukocyte Interleukin Injection) treatment groups and not in the control group |
| 2022-09-07 | CEL-SCI Corporation | Results CEL-SCI Corporation Issues Letter to Shareholders cel-sci.com ↗
The most important result of our study is this: 16% (34) of Multikine patients in the radiation-only group (212) in our Phase 3 study had at least a 30% tumor reduction within just a few weeks of treatment before surgery. |
| 2022-08-19 | CEL-SCI Corporation | Results CEL-SCI Corporation Announces Phase 3 Multikine® Head and Neck Cancer Results Posted on Clinicaltrials.gov cel-sci.com ↗
CEL-SCI Corporation (NYSE American: CVM) announced today that the results of its 10-year IT-MATTERS pivotal Phase 3 clinical trial in head and neck cancer with its investigational immunotherapy Multikine®* (Leukocyte Interleukin, Injection) have been posted on clinicaltrials.gov per U.S. government requirements. |
| 2022-06-07 | CEL-SCI Corporation | Results CEL-SCI Presents Phase 3 Multikine Head & Neck Cancer Data at ASCO cel-sci.com ↗
Safety results were not significantly different between treatment groups. |
| 2022-05-27 | CEL-SCI Corporation | Results CEL-SCI Announces Publication of ASCO 2022 Abstracts cel-sci.com ↗
“Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” |
| 2021-06-28 | CEL-SCI Corporation | Results CEL-SCI's Multikine® Immunotherapy Produces Significant 14.1% 5-Year Survival Benefit (62.7% Vs 48.6%) in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head and Neck Cancer Phase 3 Study cel-sci.com ↗
Data indicate significant overall survival (OS) benefit for patients who received the Multikine® treatment regimen followed by surgery and radiotherapy, but not for patients who had chemotherapy added to the same treatment. |
| 2017-12-07 | CEL-SCI Corporation | Results CEL-SCI Reports Recent Data Review By the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study cel-sci.com ↗
The IDMC recommends continuing the study. |
| 2017-08-14 | CEL-SCI Corporation | Regulatory U.S. FDA Removes Clinical Hold on CEL-SCI's Phase 3 Head & Neck Cancer Trial cel-sci.com ↗
the clinical hold that had been imposed on the Company’s Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed |
| 2017-05-24 | CEL-SCI Corporation | Regulatory CEL-SCI Corporation Releases Letter to Shareholders cel-sci.com ↗ |
| 2016-11-21 | CEL-SCI Corporation | Regulatory CEL-SCI Submits Response to FDA in Connection with Partial Clinical Hold on Phase 3 Clinical Trial cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) announced today that it has submitted its response to the U.S. Food and Drug Administration (FDA) regarding the previously announced partial clinical hold of CEL-SCI’s Phase 3 clinical trial of its investigational drug Multikine* (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck. |
| 2016-10-21 | CEL-SCI Corporation | Regulatory CEL-SCI Provides Update on Partial Clinical Hold on Phase 3 Clinical Trial cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) announced today: following up on our press release issued on September 26, 2016, we have received the Partial Clinical Hold letter from the U.S. Food and Drug Administration (FDA). |
| 2016-09-26 | CEL-SCI Corporation | Regulatory CEL-SCI Reports Clinical Hold on Head and Neck Cancer Study cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) announced today that it has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Multikine (Leukocyte Interleukin Injection) Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold. |
| 2015-06-08 | CEL-SCI Corporation | Regulatory CEL-SCI is Cleared to Start Patient Enrollment for Its Phase 3 Cancer Immunotherapy Trial in Thailand cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced that CEL-SCI is now cleared to start patient enrollment in Thailand in its ongoing Phase 3 trial with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer. |
| 2015-05-13 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Authorization to Conduct Its Phase 3 Multikine Trial in Italy cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced that the Italian Medicines Agency (AIFA) has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. |
| 2015-05-11 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Authorization to Conduct Its Phase 3 Multikine Trial in Spain cel-sci.com ↗
Spain is the 22nd country to authorize CEL-SCI’s Phase 3 trial for patient enrollment. |
| 2015-02-11 | CEL-SCI Corporation | Regulatory The Philippines is the 19th Country to Clear CEL-SCI for Patient Enrollment in Its Phase III Head and Neck Cancer Trial cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Philippines Regulatory Agency (PFDA) has cleared the Company to commence patient enrollment of the Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the Philippines. |
| 2015-01-26 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Regulatory Clearance to Expand Its Phase III Head and Neck Cancer Trial into Romania cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) today announced the Romanian Ministry of Health has cleared the Company to begin patient enrollment and conduct its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Romania. |
| 2014-07-30 | CEL-SCI Corporation | Regulatory France Becomes 17th Country to Clear CEL-SCI for Patient Enrollment in Its Global Phase III Head and Neck Cancer Trial cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) today announced that the French Agency for the Safety of Health Products has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in France. |
| 2014-07-23 | CEL-SCI Corporation | Regulatory CEL-SCI Has Been Cleared to Begin Patient Enrollment cel-sci.com ↗
Yesterday morning, CEL-SCI Corporation (NYSE MKT:CVM) announced that Turkey's Ministry of Health had cleared the company to begin patient enrollment in CEL-SCI's global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine. |
| 2014-07-22 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Regulatory Clearance to Expand Phase III Head and Neck Cancer Trial into Turkey cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) today announced that Turkey’s Ministry of Health has cleared the company to begin patient enrollment in CEL-SCI’s global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). |
| 2014-07-17 | CEL-SCI Corporation | Regulatory CEL-SCI Expands Its Phase III Head and Neck Cancer Trial into Sri Lanka cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) today announced that Sri Lanka’s Ministry of Health has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Sri Lanka. |
| 2014-06-02 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Approval to Expand Its Immunotherapy Phase III Head and Neck Cancer Trial into the United Kingdom cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT:CVM) today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted regulatory approval to begin the Company’s Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the United Kingdom (UK). |
| 2014-02-03 | CEL-SCI Corporation | Regulatory U.S. Navy Approves Start of CEL-SCI's Phase I Trial for Treatment of Anal Warts in HIV/HPV Co-Infected Patients cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) announced today the Institutional Review Board (IRB) of the U.S. Navy’s Naval Medical Center San Diego (NMCSD), has approved the start of a Phase I dose escalation study of the Company’s investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts. |
| 2014-01-23 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Government Approval in Serbia to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer cel-sci.com ↗
Serbia is the 11th country from which approval to participate in the world’s largest Phase III trial for the treatment of head and neck cancer has been obtained. |
| 2013-12-05 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Government Approval in Bosnia and Herzegovina to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer cel-sci.com ↗
Bosnia and Herzegovina is the 10th country into which CEL-SCI has now expanded its global Phase III trial. |
| 2013-11-12 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Croatian Government Approval to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer cel-sci.com ↗
CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Health Protection Administration, Ministry of Health, of the Croatian Republic to begin enrollment of subjects into the Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). |
| 2012-10-22 | CEL-SCI Corporation | Results CEL-SCI Corporation Announces Results of Interim Review of Data from Its Ongoing Phase III Head and Neck Cancer Trial by Independent Data Monitoring Committee (IDMC) cel-sci.com ↗
The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study. |
| 2011-08-18 | CEL-SCI Corporation | Regulatory CEL-SCI Addresses Warning Letter in Regard to Statements on Its Corporate Website cel-sci.com ↗
The Warning Letter was issued by DDMAC on August 5, 2011. |
| 2011-08-17 | CEL-SCI Corporation | Regulatory CEL-SCI Receives Key Chinese Patent for Its Investigational Cancer Therapy Multikine (Leukocyte Interleukin, Injection) cel-sci.com ↗
today announced that the Chinese patent office has issued a key patent covering CEL-SCI’s investigational cancer drug, Multikine® (Leukocyte Interleukin, Injection)*. |
All press releases naming this drug 55 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Leukocyte Interleukin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03038828 ↗ |
| Route | Other | “perilesional Multikine injections” NCT02115919 ↗ |