Harnessing the immune system to fight cancer

Source: www.npr.org Author: staff When Barbara Marder was diagnosed with lung cancer three years ago, she had part of her right lung removed, went through a round of chemotherapy and tried to move on with her life. "I had hoped that everything was fine — that I would not create difficulty for my children, that I would get to see my grandchildren grow up," says Marder, 73, of Arnold, Md. But a routine scan a year later found bad news: The cancer was back — this time in her other lung. "I was very disappointed," says Marder. She knew her prognosis was grim. "I decided at that point that ... I should think about the fact that perhaps this was going to advance rapidly at this point. And check and make sure: Is my will in order? What should I do so that my children aren't left with a mess to clean up in my house?" But Marder didn't give up. She started exploring her options, which eventually brought her to Johns Hopkins in Baltimore, where doctors are testing a new type of cancer treatment known as immunotherapy. "Immunotherapy for cancer means developing treatments to harness your immune system and using your own immune system to fight the cancer," says Dr. Julie Brahmer, an associate professor of oncology and Marder's doctor. Scientists have been trying to do this for decades. After all, our immune systems can fight off all kinds of health threats. So, why not cancer? But nothing seemed [...]

2015-02-11T08:10:05-07:00February, 2015|Oral Cancer News|

Number of immune cells in tumors could soon help predict and treat cancers

Source: www.science20.com Authors: Emma King, University of Southampton and Christian Ottensmeier, University of Southampton Immune cells in the blood primarily defend us against infection. But we’re now learning that these cells can also keep us free from cancer. Patients with less efficient immune systems such as organ transplant recipients or those with untreated HIV, for example, are more susceptible to cancers. It is also becoming increasingly apparent that we can use immune cells to predict survival in people who do develop cancer. And that, in fact, there are immune cells within cancers. Head and neck cancer underway The number of immune cells inside a tumor can hugely vary: some patients have vast numbers while some have very few. In a recent study, we showed that in head and neck cancers, the survival of a patient depends on how many immune cells are within the tumor. This could be a valuable way of individualizing cancer treatments. Patients with lots of immune cells, for example, could be offered less toxic cancer treatment while those with few immune cells may need more aggressive treatment to improve their chances of survival. Not all immune cells within the tumor are able to “attack” the cancer. By looking at specific cell markers – proteins on the cell exterior that allow us to see whether, for example, cells are exhausted – we can determine which individual immune cells in the tumor will be effective in tackling the cancer, or if they are exhausted and not [...]

2014-09-26T06:21:57-07:00September, 2014|Oral Cancer News|

Advaxis requests orphan drug designation for treatment of HPV-associated head and neck cancer with ADXS-HPV

Source: www.marketwatch.com Author: press release Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer. There are about 50,000 new cases of head and neck cancer annually, with about 15,000 deaths. HPV infection is estimated to account for 20-50% of current incidence. Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven year market exclusivity period. "HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in [...]

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 [...]

Advaxis recruiting for HPV+ head and neck cancer trial

Source: www.cancertreatment.net Author: Ross Bonander Advaxis is announcing the enrollment of patients into the REALISTIC Phase I/II trial sponsored by Cancer Research UK to evaluate ADXS-HPV for the treatment of HPV-positive head and neck cancer. HPV has been linked to as many as seventy percent of all head and neck cancers. ADXS-HPV is a next-generation immunotherapy that acts as a therapeutic vaccine and is being tested in trials against HPV-associated diseases, including cervical cancers. Cancer Research UK assumes all patient costs. Advaxis seeks to recruit 45 patients. The REALISTIC trial is being carried out at the Aintree Hospital at the University of Liverpool, the Royal Marsden Hospital at the University of London, and the Cardiff Hospital at the University of Wales. Qualified patients will have already received treatment for head and neck cancer, either surgery, radiotherapy, chemotherapy, or a combination of treatments. Head and neck cancers account for roughly three percent of all cancers in the US, according to the American Cancer Society. They are more commonly diagnosed in men than women, and while they are traditionally linked to smoking and to alcohol consumption, HPV-related oropharyngeal cancers are on the rise among white males under 50 years of age. "We are pleased to be working with an internationally-renowned oncology group to further expand the ADXS-HPV clinical development program to another HPV-associated tumor type," said Advaxis Chairman & CEO Thomas A. Moore. "Through this collaboration, we hope that our proprietary technology will be able to offer a new treatment option to [...]

Queensland researchers make cancer treatment breakthrough

Source: HealthCanal.com The culmination of 10 years of collaborative research between scientists from the Queensland Institute of Medical Research (QIMR) and The University of Hong Kong (HKU) Li Ka Shing Faculty of Medicine has led to a significant breakthrough in the treatment of nasopharyngeal carcinoma (NPC), an aggressive throat cancer with a high prevalence in South-East Asia. NPC is associated with Epstein-Barr virus infection in a manner similar to the association of hepatitis B virus and liver cancer. By using immunotherapy, the human body’s own immune system was used to successfully fight the disease. Professor Rajiv Khanna who heads the Australian Centre for Vaccine Development at QIMR said by enhancing the immune cells of NPC patients they have doubled the survival time of terminally ill patients. “The presence of EBV in the cancer cells gives the body’s immune system a definite target to help battle the NPC, resulting in few side-effects,” Professor Khanna said. “Patients who participated in the trial were in the late stages of the cancer and quite unwell, so it was important to ensure the treatment was non-invasive, non toxic and did not damage healthy cells. “By offering such targeted treatment, we were able to increase the expected time of patient survival from 200 to over 500 days, which is an extremely positive result. “We believe that if we offer this treatment in the earlier stages of NPC, accompanied with chemotherapy and radiation, we can further enhance survival rates.” Twenty four NPC patients were recruited at the [...]

2012-02-01T17:06:54-07:00February, 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 [...]

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 [...]

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

HPV is changing the face of head and neck cancers

Source: www.hemonctoday.com Author:  Christen Cona In February, at the Multidisciplinary Head and Neck Cancer Symposium in Chandler, Ariz., Maura Gillison, MD, PhD, professor and Jeg Coughlin Chair of Cancer Research at The Ohio State University in Columbus, presented data that showed that the proportion of all head and neck squamous cell cancers that were of the oropharynx — which are most commonly HPV-positive cancers — increased from 18% in 1973 to 32% in 2005. In addition, studies from the United States, Europe, Denmark and Australia indicate that HPV-positive patients have a more than twofold increased cancer survival than HPV-negative patients, according to Gillison. With the rising incidence of HPV-related oropharynx cancers, it will soon be the predominant type of cancer in the oral or head and neck region, according to Andy Trotti, MD, director of radiation oncology clinical research, H. Lee Moffitt Cancer Center & Research Institute, in Tampa, Fla. “We should be focusing on HPV-related oropharyngeal cancer because it will dominate the field of head and neck cancers for many years,” he said during an interview with HemOnc Today . “It is certainly an important population for which to continue to conduct research.” Because HPV-associated oropharyngeal cancer is emerging as a distinct biological entity, the recent rise in incidence will significantly affect treatment, and prevention and screening techniques, essentially reshaping current clinical practice. Social change driving incidence In the analysis performed by Gillison and colleagues, trends demonstrated that change in the rates of head and neck cancers [...]

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.

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