Date: 2016-11-21
Type of information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: CEL-SCI Corporation (USA -VA)
Product: Multikine® (Leukocyte Interleukin, Injection)
Action
mechanism: protein/cytokine. Multikine® is a patented defined mixture of biologically active, natural cytokines that simulate the body’s healthy immune response. The cytokine mixture includes interleukins, interferons, chemokines, and colony-stimulating factors. This combination immunotherapy is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. This immunotherapeutic agent is developed under a licensing agreement with Teva.
Disease: head and neck cancer
Therapeutic area: Cancer - Oncology
Country: Austria, Bosnia, Canada, Croatia, France, Hungary, India, Israel, Poland, Romania,Russia, Serbia, Sri Lanka, Taiwan, Turkey, UK, Ukraine, USA
Trial
details: CEL-SCI's Phase III clinical trial (IT-MATTERS) is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for treatment naive subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus subjects treated with standard of care only. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. (NCT01265849)
Latest
news: * On November 21, 2016, CEL-SCI Corporation announced that it has submitted its response to the FDA regarding the previously announced partial clinical hold of CEL-SCI's Phase 3 clinical trial of Multikine* (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck. * On October 21, 2016, CEL-SCI Corporation announced that the company has received the Partial Clinical Hold letter from the FDA. CEL-SCI has started working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted. * On June 8, 2015, CEL-SCI Corporation announced that CEL-SCI is now cleared to start patient enrollment in Thailand in its ongoing Phase 3 trial with Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer. Thailand is the 24th country to authorize CEL-SCI's Phase 3 trial for patient enrollment.As of May 31, 2015, 463 patients had been enrolled in the global Phase 3 study. * On May 11, 2015, CEL-SCI Corporation announced that Spain's Agency for Medicinal Products and Medicinal Devices has authorized the Company to commence patient enrollment for its ongoing Phase 3 trial of 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. Spain is the 22nd country to authorize CEL-SCI's Phase 3 trial for patient enrollment. CEL-SCI is aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study. * On April 13, 2015, CEL-SCI Corporation announced that Aintree University Hospital, in Liverpool, England, has become a clinical site for the Company's global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This is the first center to join the Multikine Phase III study in the UK. The Principal Investigator for the trial site is Professor Richard Shaw. He serves as Honorary Consultant in Oral & Maxillofacial / Head and Neck Surgery at Aintree University Hospital and is a surgeon specializing in head and neck cancers at the University of Liverpool. * On February 27, 2015, CEL-SCI Corporation announced the Ministry of Health of the Republic of Belarus has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of Multikine* (Leukocyte Interleukin, Injection). Belarus is the 21st country to approve CEL-SCI's Phase III trial. * On February 19, 2015, CEL-SCI Corporation announced the Ministry of Health Malaysia has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of Multikine* (Leukocyte Interleukin, Injection) in Malaysia. Malaysia is the 20th country to approve CEL-SCI's Phase III trial, which now has over 350 patients enrolled. * On January 26, 2015, CEL-SCI Corporation 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 Multikine* (Leukocyte Interleukin, Injection) in Romania. * On December 2, 2014, CEL-SCI Corporation announced that during the past three months it has enrolled 58 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for Multikine* (Leukocyte Interleukin, Injection). This quarterly enrollment represents a more than eight fold increase in enrollment compared to the same September to November quarter in 2013 when seven patients were enrolled. This brings the total number of patients enrolled in the Phase III study to about 310. A total of 880 patients are expected to be enrolled, through over 100 clinical centers in over 20 countries. Twenty patients were enrolled in the study in November 2014. * On October 3, 2014, CEL-SCI Corporation announced that during the month of September the Company enrolled 16 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for Multikine* (Leukocyte Interleukin, Injection). * On September 3, 2014, CEL-SCI Corporation announced that it enrolled 20 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for Multikine* (Leukocyte Interleukin, Injection) during August 2014. This brings the total study enrollment to 252 patients. * On August 19, 2014, CEL-SCI Corporation announced its Phase III Head and Neck Cancer clinical trial of Multikine* (Leukocyte Interleukin, Injection) has added Centre Hospitalier Universitaire de Québec (CHUQ)'s L'Hotel Dieu de Quebec to its growing number of clinical sites in North America. CHUQ is a network of three teaching hospitals affiliated with the medical school of Université Laval and several specialized institutions in Quebec City. CEL-SCI plans to activate additional clinical sites for accelerated patient enrollment in Canada. The Principal Investigator for CEL-SCI's Phase III trial at CHUQ is Dr. André Fortin, a radiation oncologist and visiting professor. He is responsible for the research protocols of radiation therapy for the oncology group at CHUQ. Dr. Fortin has extensive expertise in the treatment of cancers using radiation therapy for head and neck, pulmonary, and digestive cancers. He is very involved in clinical research within the department as evidenced by his numerous publications. * On August 1, 2014, CEL-SCI Corporation announced that during the month of July the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for itsinvestigational immunotherapy Multikine*. A total of 47 patients were enrolled over the past three months, with 14 in May, 19 in June, and 14 in July. This marks a 15% increase over the prior three month period when a total of 41 patients were enrolled. "We reached an important milestone in July with total patient enrollment reaching 232, which is over one-quarter of the total 880 patients we expect to enroll by the end of 2015. We are on track with the pace of enrollment, which should accelerate in the fall based on the increasing number of clinical centers joining our study," stated CEL-SCI Chief Executive Officer Geert Kersten. "In the past three months alone, we have received clearances to expand the trial into the United Kingdom, Austria, Sri Lanka, Turkey and France, while we also continue to add clinical sites in North America." * On July 30, 2014, CEL-SCI Corporation 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* in France. In the past three months CEL-SCI has also received governmental clearance to expand its trial into the United Kingdom, Austria, Sri Lanka and Turkey. CEL-SCI's Phase III trial is assessing the Company's investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. * On July 8, 2014, CEL-SCI Corporation announced that it has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to begin patient enrollment in the Company's Phase III Head and Neck Cancer clinical trial of its cancer immunotherapy Multikine*. Austria is the 14th country to participate in CEL-SCI's trial which is already active in numerous clinics around the world. Further expansion of CEL-SCI's Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers through by the end of 2015. Over 200 patients are already enrolled in, and being treated with Multikine. * On July 1, 2014, CEL-SCI Corporation announced that during the month of June the Company enrolled 19 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for itsinvestigational immunotherapy Multikine*. A total of 54 patients were enrolled over the past three months, with 21 enrolled in April, 14 in May, and 19 in June. This marks a 93% increase over the prior three month period when a total of 28 patients were enrolled, with 8 in January, 6 in February, and 14 in March. Since the beginning of 2014, the Company has enrolled a total of 82 patients. This compares with 10 patients enrolled in the first half of 2013. So far, a total of 218 patients have been enrolled in the study. The study is expected to complete enrollment of 880 patients by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries. * On June 2, 2014, CEL-SCI announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted regulatory approval to begin the Phase III Head and Neck Cancer clinical trial of its cancer immunotherapy treatment Multikine* in the UK. The UK becomes the 13th country to join the trial. Several hospitals and medical clinics in the UK are expected to participate in the Phase III trial for the treatment of head and neck cancer. Further expansion of the trial is underway with a goal to have a total of about 100 clinical centers through 20 countries by the end of 2015. * On December 5, 2013, CEL-SCI has announced that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine*. Bosnia and Herzegovina is the 10th country into which CEL-SCI has now expanded its global Phase III trial. This also marks the Company's milestone in receiving approval to commence accrual in one-half the number of countries in the currently planned expansion of the study. The trial is expected to expand into a total of approximately 100 clinical centers in 20 countries. CEL-SCI expects to enroll approximately 30 patients in Bosnia and Herzegovina through three clinical centers. CEL-SCI is currently accelerating enrollment in its Phase III clinical trial for Multikine by adding a large number of clinical centers. In addition to these centers, the trial also benefits from clinical centers in CEL-SCI's partners' territories, Teva Pharmaceuticals in Israel and Orient Europharma in Taiwan. * On November 12, 2013, CEL-SCI has announced 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*. Croatia is the ninth country into which CEL-SCI has expanded its global Phase III trial. The trial is expected to be conducted in about 100 clinical centers worldwide. CEL-SCI expects to enroll approximately 40 patients in Croatia through four clinical centers. * On November 5, 2013, CEL-SCI announced that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine investigational new drug immunotherapy was completed by the Independent Data Monitoring Committee (IDMC). The Committee, which is comprised of world class leaders in head and neck cancer, concluded that the data raised no safety concerns, and recommended that the Phase III study continue unmodified. * On June 13, 2011, CEL-SCI has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy, at the National Institute of Oncology in Budapest, Hungary. Enrollment is expected to start soon in this center. The study is already ongoing at twelve clinical sites in the United States, Canada, Poland and India. The total study is expected to enroll about 880 head and neck cancer patients in over 40 hospitals in 9 countries. * On May 19, 2011, CEL-SCI has commenced its global Phase III clinical trial for Multikine® in Russia at the State Budgetary Healthcare Institution of Sverdlovsk Region - Sverdlovsk Regional Oncology Center in Ekaterinburg, Russia. * On May 13, 2011, CEL-SCI has commenced its global Phase III clinical trial for Multikine®, at the Centrum Onkologii - Instytut im. Marii Skodowskiej-Curie, Warsaw, Poland, the first clinical site in Poland and the first center in the EU. Currently, the study is actively recruiting patients in the United States and India as well. The Company expects to enroll approximately 85 patients at five clinical sites in Poland. The total study is expected to enroll about 880 head and neck cancer patients in about 48 hospitals in 9 countries on three continents. CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively. The goal of this study is to establish Multikine® as a first-line standard of care therapy in treating newly diagnosed, not yet treated head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted and is called IT-MATTERS, an acronym for: Immunotherapy Multikine Anti Tumor Treatments.
