Multikine – Oral Cancer News

Interim results from CEL-SCI’s Multikine Phase III study on head and neck cancer

Source: www.news-medical.net CEL-SCI Corporation announced today that an interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine (Leukocyte Interleukin, Injection) investigational immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no safety concerns. The IDMC also indicated that no safety signals were found that would call into question the benefit/risk of continuing the study. CEL-SCI considers the results of the IDMC review to be important since studies have shown that up to 30% of Phase III trials fail due to safety considerations and the IDMC's safety findings from this interim review were similar to those reported by investigators during CEL-SCI's Phase I-II trials. Ultimately, the decision as to whether a drug is safe is made by the FDA based on an assessment of all of the data from a trial. IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients in ongoing trials especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time (3-5 years). The committee's membership should include physicians and clinical trial scientists knowledgeable in the appropriate disciplines, including statistics. The CEL-SCI IDMC includes prominent physicians and scientists from major institutions in the USA and abroad who are key opinion leaders in head and neck cancer and who are knowledgeable in all of the disciplines related to CEL-SCI's study, including statistics. The Multikine Phase III study is enrolling [...]

Oral Cancer Foundation News Team - A2012-10-23T07:33:16-07:00October, 2012|Oral Cancer News|

CEL-SCI gets Israeli nod to commence phase III trial of multikine in head and neck cancer

Source: www.pharmabiz.com Author: staff CEL-SCI Corporation announced that the State of Israel's Ministry of Health has given approval to begin enrolment of subjects for a phase III clinical trial of Multikine in Israel. Israel is one of nine countries to participate in this global phase III trial. The phase III trial will be conducted in approximately 48 clinical centres. CEL-SCI's partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centers in Israel. The phase III trial started in the United States in late December 2010 and is expected to commence in other countries around the world within the next 30-60 days. Multikine is the company's flagship immuno-therapy developed as a first-line standard of care in treating head and neck cancer. CEL-SCI's phase III clinical trial is an open-label, randomized, controlled, multi-centre study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated 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 the subjects treated with standard of care only. CEL-SCI's 880 patient phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the [...]

Oral Cancer Foundation News Team - A2011-04-03T09:45:51-07:00April, 2011|Oral Cancer News|

Cel-Sci to bump standard of care in head, neck cancer

Source: www.bioworld.com Author: Catherine Shaffer Cel-Sci Corp. began a carefully designed Phase III trial of Multikine, its investigational immunotherapy for head and neck cancer. Because Multikine is designed to recruit the support of a mostly healthy immune system, Cel-Sci is making a headlong charge at the goal of first-line therapy, instead of trying to develop the product in patients who have already received surgery, radiation and chemotherapy, and have suppressed or damaged immune systems as a result. If Cel-Sci can prove the therapy works in the narrow three-week testing window granted by the FDA, Multikine stands to replace a standard of care that has changed little in half a century. "It makes no sense to develop an immunotherapy product for late-stage patients. You should develop it as a first line therapy, ahead of radiation or chemotherapy," Cel-Sci CEO Geert Kersten told BioWorld Today. Vienna, Va.-based Cel-Sci's clinical trial plan takes advantage of a nearly inevitable delay of up to six weeks between diagnosis and surgery in most head and neck cancers. The FDA has allowed Cel-Sci a three-week period to give Multikine to patients before they commence with surgery, radiation, and chemotherapy. This will not deprive any patients of the best possible standard-of-care while they also try an experimental therapy. Head and neck cancer strikes about 500,000 people annually worldwide. Some causal factors include smoking, drinking and chewing tobacco. Most cases are diagnosed outside the U.S., and about two-thirds of patients appear with advanced disease. The standard treatment for it [...]

Oral Cancer Foundation News Team - A2010-12-30T16:16:36-07:00December, 2010|Oral Cancer News|

Completion of Cel-Sci’s new facility signals that long awaited phase III trial is imminent

Source: www.reuters.com Author: press release BioMedReports, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, was given an exclusive tour of CEL-SCI Corporation's new, state-of-the-art manufacturing facility near Baltimore, MD where the potentially ground breaking cancer immunotherapy treatment, Multikine, will be manufactured to support an upcoming Phase III clinical trial. Multikine is the company's flagship immunotherapeutic head and neck cancer treatment and is the first immunotherapeutic agent being developed as a first-line standard of care cancer treatment. Because it required a very specific cold-fill process for manufacturing, the Phase III trials have been on hold as Cel Sci dedicated the majority of their time and resources to build the new best-in-class production facility. Additionally, once the facility is validated, Cel Sci will become the only entity offering the 4°C cold fill on a contract basis, meaning the potential to bring in significant revenue as an added bonus does exist.

Oral Cancer Foundation News Team - A2009-10-26T14:46:03-07:00October, 2009|Oral Cancer News|