>>AUSTIN, Texas, Jan. 8 /PRNewswire/ -- Introgen Therapeutics Inc. (Nasdaq: INGN - news) announced today the publication of a new study in the journal ``Cancer'' describing the use of INGN 201, Introgen's adenoviral-p53 product candidate, to treat the pre-cancerous cells that cause certain head and neck cancers. The results of this preclinical study suggest that early treatment with INGN 201 may prevent development of invasive cancer of the mouth in patients with the pre-cancerous condition known as oral dysplasia.
Deborah R. Wilson, Ph.D., associate vice president of clinical research for Introgen and co-author of the article said, ``INGN 201 is currently the subject of two Phase 3 clinical trials for treating advanced stages of head and neck cancer, namely recurrent and treatment refractory disease. Now, it also shows promise as a prophylactic agent to treat the very earliest forms of the disease.''
Using in vitro models that approximate premalignant and early malignant disease, the authors demonstrated that treatment with INGN 201 decreases the growth of these cells and triggers them to die via apoptosis, or programmed cell death, in a positive dose response fashion. Untreated, these cells display altered growth characteristics of cancer, and have lost cell growth regulatory mechanisms that can be restored by the transfer of the p53 gene through treatment with INGN 201.
These studies were designed by George H. Yoo, M.D., of the Department of Otolaryngology-Head and Neck Surgery at Wayne State University in Michigan, and conducted in his laboratory, in collaboration with Introgen.
``We have designed a Phase 1/2 clinical study to evaluate the safety and effectiveness of INGN 201 as an oral treatment for patients with dysplasia,'' stated James Merritt, M.D., Introgen's chief medical officer. ``This is the first step in developing a preventative therapy for head and neck cancer. If the progression of premalignant cells into cancer can be avoided, the prognosis for these patients should be greatly improved.''
Cancer can affect any part of the oral cavity, including the lip, tongue, mouth and throat. Risk factors for oral cancer include the use of cigarettes, cigar or pipe smoking, use of smokeless tobacco and excessive consumption of alcohol. Last year an estimated 30,200 new cases of oral cancer were detected with incidence rates more than twice as high in men than women and greatest in men over the age of 40.
Each year, more than 100,000 people worldwide are diagnosed with head and neck cancer. No significant progress has been made in recent years to improve the survival of patients with head and neck cancer. While surgery and radiation may cure early stages of this disease, a majority of patients are initially diagnosed with advanced disease. Despite treatment, many of these patients will relapse. Once a tumor recurs, the disease is almost always fatal within one year. Currently patients with early stage head and neck cancer, or patients who are cured from advanced cancer, have a significant chance of dying from a second primary tumor. Disruption of the p53 tumor suppressor pathway is one of the early events that occur during the development of head and neck cancer. Most head and neck cancers have lost p53 activity due to either gene mutation or loss of protein function. Patients who have already been successfully treated for cancers of the head and neck are especially at risk for second primary tumors and are monitored very carefully for signs of dysplasia.
The on-line version of the manuscript is published in Volume 94, Issue 1 and available at www.interscience.wiley.com .<<
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