CEL-SCI Files Phase III Clinical Trial Application With FDA

1/4/2005 Vienna, VA press release PR Newswire CEL-SCI CORPORATION (Amex: CVM) has submitted a Phase III clinical trial protocol to the U.S. Food and Drug Administration ("FDA") for the use of its investigational immunotherapy drug Multikine(R) in the treatment of advanced primary squamous cell carcinoma of the oral cavity. Additional information in support of and to provide the rationale for the Phase III trial (final reports of clinical trials conducted with Multikine to date and manufacturing and testing information) was included with this submission. The protocol was designed in consultation with a group of recognized experts in the field of head & neck cancer therapy to develop the conclusive evidence of the safety and efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity that would be required to license the product. The Company plans to meet with the FDA to discuss the proposed Phase III clinical trial over the next several months and obtain the agency's approval to initiate the study. Geert Kersten, Chief Executive Officer of CEL-SCI said, "We believe that Multikine has the ability to improve the success rate of first line therapy in head & neck cancer and this protocol is designed to prove our belief." Head and neck cancer is an aggressive cancer that affects about 500,000 people per annum worldwide. Multikine is an immunotherapeutic agent consisting of a mixture of naturally occurring cytokines including interleukins, interferons, chemokines and colony-stimulating factors. Multikine has completed several Phase II clinical trials [...]

2009-03-25T18:22:02-07:00January, 2005|Archive|

Clinical Trial: Can Green Tea Reduce the Risk of Mouth Cancer?

1/4/2005 Sheldon Sax Oral Cancer Foundation The Cancer Institute of New Jersey and the New Jersey Dental School are undertaking a clinical trial of green tea and its relationship to oral precancers. If you live in New Jersey and would like to participate in the clinical trial, you should contact your dentist about eligibility or telephone 1-866-654-9898. Here is the text of the original announcement: Help us find out by joining a study being conducted at The Cancer Institute of New Jersey, the state’s only National Cancer Institute-designated Comprehensive Cancer Center dedicated to cancer research, prevention, treatment and education in cooperation with the New Jersey Dental School. Mouth Cancer is the most common cancer in the head and neck region of the body and is often fatal. Mild or moderate dysplasia, which may appear as white or grey patches, is a potentially pre-cancerous condition in the mouth. A clinical trial is underway to see the effects of green tea on these white or grey patches. If you have been diagnosed with mild or moderate dysplasia or have white or grey patches in your mouth, talk to your dentist or contact The Cancer Institute of New Jersey to determine your eligibility for this study. If eligible, you will be asked to consume lozenges 8 times a day for 12 weeks and your participation will last for 24 weeks. If interested in participating, please call 1-866-654-9898. Original Source: The Cancer Institute of New Jersey

2009-03-25T18:21:25-07:00January, 2005|Archive|

Web Site Offers Help For Quitting Chew

1/1/2005 Press & Dakotan, Yankton Daily Quitting tobacco is one of the most popular New Year's resolutions, but the key to success is to create a quit plan that includes planning for tough situations, dealing with withdrawal, and getting support from others. Chewers and dippers can now create their own effective quit plans at the ChewFree.com Web site. Sponsored by the National Center Institute, ChewFree.com is a free, self-help quitting program offered as part of a research study by Oregon Research Institute. "Many people mistakenly believe that they can quit with will power alone," says Dr. Herb Severson of Oregon Research Institute, the project director. "Our research has shown, however, that chewers and dippers can by most successful if they take the time to make a plan. ChewFree.com provides those interested in quitting with the tools they need." More than 6 million Americans use smokeless tobacco products regularly, contributing to as many as 9,000 U.S. cancer deaths each year. The ChewFree.com quitting program addresses the special difficulties faced by chew and snuff users, who have fewer quitting resources than do smokers. All participants will have access to a web site containing information and quitting resources that have already helped thousands of chewers to quit. Participants are asked to complete research questionnaires on-line to help evaluate the program. For more information or to enroll in the quitting program, log on to www.chewfree.com. Facts About Smokeless Tobacco -- South Dakota Smokeless tobacco use is widespread, especially among young men. More than five [...]

2009-03-25T18:20:10-07:00January, 2005|Archive|

Coming between cowboys and chew

12/30/2004 Ken Carlson The Modesto Bee (modbee.com) Health agency out to get Oakdale Rodeo to sever ties with maker of snuff A campaign backed by the Stanislaus County Health Services Agency is trying to buck a tobacco company's sponsorship of the Oakdale Rodeo. And since the Oakdale Saddle Club, which puts on the rodeo every April, so far has refused to cut ties with the U.S. Smokeless Tobacco Co., the Health Services Agency plans another tack: a billboard due to go up next week along Highway 108 between Riverbank and Oak-dale. The message: "Don't let spit tobacco stain our rodeo." "Spit tobacco" is smokeless tobacco, such as Copenhagen and Skoal, two of U.S. Smokeless Tobacco's products. The company is the leading producer of brand-name smokeless tobacco, also called chew and snuff. The Buck Tobacco Sponsorship campaign is targeting rodeos in Stanislaus, Monterey, San Luis Obispo, Santa Barbara and San Diego counties. Campaign officials said rodeos are family events where cancer-causing products, such as tobacco, should not be promoted. Michael Wagner, an Oakdale Saddle Club board member who oversees sponsorships, said he has talked with Buck Tobacco campaign officials for several months. As of now, the club has no intention of ending its relationship with U.S. Smokeless Tobacco, he said. But, he added, the club will ensure that the smokeless tobacco sampling tent at 2005's rodeo will be nowhere near concessions that attract youngsters. "We want to work with them, as best we can, so we can retain the benefits of [...]

2009-03-25T18:19:31-07:00December, 2004|Archive|

COX-2 expression correlates with VEGF-C and lymph node metastases in patients with head and neck squamous cell carcinoma

12/29/2004 Panayiotis A Kyzas1, Dimitrios Stefanou1 and Niki J Agnantis1 Modern Pathology (2005) 18, 153-160, advance online publication, 23 July 2004 Recent observations suggest an implication of the cyclooxygenase-2 (COX-2) in tumor lymphangiogenesis through an upregulation of vascular endothelial growth factor-C expression. It is unknown whether this mechanism also acts in squamous cell carcinoma of the head and neck region. We performed a retrospective study of 70 patients with head and neck squamous cell carcinoma in order to investigate whether COX-2 immunohistochemical expression correlates with vascular endothelial growth factor-C expression. We also examined the association of the expression of these molecules with clinicopathologic parameters (especially lymph node status) and outcome for these patients. We performed immunostaining on formalin-fixed, paraffin-embedded tissue sections by the routine streptavidin-biotin peroxidase labeled procedure. Increased cyclooxygenase-2 expression was observed in 30 of the 68 tumor samples (44%), while high vascular endothelial growth factor-C expression occurred in 26 of the 68 tumor samples (38%). High expression of the two proteins was correlated with the presence of lymph node metastasis at the time of diagnosis, and the observed association was even stronger when there was overexpression for both the antibodies (P<0.001). High expression of vascular endothelial growth factor-C, but not of COX-2 was correlated with increased mortality in patients with oral-larynx squamous cell carcinoma. When multivariate Cox regression model was applied, the presence of lymph node metastasis at the time of diagnosis, combined with overexpression of both the antibodies, was the only independent prognostic factor for mortality of [...]

2009-03-25T18:04:06-07:00December, 2004|Archive|

Ex-smoker uses voice he has left as warning

12/29/2004 no attribution The Tennessean (Tennessean.com) Hugh Hankins talks into a small electronic microphone held to the hole in his throat. If you've made a New Year's resolution to quit smoking, you might want to listen to what he has to say about what cigarettes did for him. ''In 1978, I had 28 grand mal brain seizures,'' Hankins told me, his voice sounding like those anonymous hidden sources you see on the television news. To speak, he presses the button on his microphone. His mouth moves, but the only sound that comes out is from the hole. ''I was in a coma for a week. In 1984, I developed throat cancer. I had 28 radiation treatments. Back then, they shot you in both sides of your throat — just burned you up. About six months after, they did a total laryngectomy. They cut you straight across the throat. I have no voice at all. I have no smell at all.'' Hankins' tale is hard to listen to, both because he is difficult at times to understand and because it's full of so many painful experiences. He has had a collapsed esophagus, a brain tumor, prostate cancer and is now on total disability. Now and then, he has to have the hole in his throat enlarged when it starts closing up. His doctors believe the majority of his health problems were caused from his long history of smoking. Still, he said, ''I'm not complaining.'' He's happy just to be alive. See [...]

2009-03-25T18:03:31-07:00December, 2004|Archive|

Alcohol May Fuel Cancer Tumor Growth

12/27/2004 Kelli Miller Stacy msn.health (content.health.msn.com) Researchers say they have discovered a new clue as to how alcohol may speed up cancer progression. Since the early 1900s, alcohol consumption has been linked to cancer, particularly of the esophagus, stomach, liver, and even the breast. Doctor's know that the more alcohol you drink, the higher your risk, but the exact role alcohol plays in cancer progression has remained a mystery. Now scientists say they've unraveled the clues behind this alcohol-cancer connection. A preliminary study, published in the Jan. 15, 2005 issue of the journal CANCER, shows, for the first time, that alcohol fuels the production of a growth factor that helps create new blood vessels inside a tumor, a process called angiogenesis. Production of these new blood vessels helps feed tumor cells. Jian-Wei Gu, MD, and colleagues from the University of Mississippi Medical Center, injected chick embryos, which contained cancer cells, with either salt water or alcohol for nine days. The alcohol content injected into the embryos was equivalent to what the researchers say is chronic alcohol administration. Based on their previous studies they say that light to moderate amounts of alcohol can induce new blood vessel growth. Embryos exposed to the alcohol had more than eight times the amount of cancer cells in their blood vessels than the saline-exposed embryos. The researchers also noted significant increases in tumor size and tumor blood vessel density, and higher levels of the vascular endothelial growth factor (VEGF) -- a protein involved in the [...]

2009-03-25T18:02:56-07:00December, 2004|Archive|

Knife boon for cancer

12/24/2004 Calcutta, India SANJAY MANDAL The Telegraph S.K. Ladla was having difficulty in swallowing and his voice had become hoarse. The doctors diagnosed the 65-year-old to be suffering from laryngo pharynx cancer — the most common variety of cancer among males in the city. In the past, such patients had no option but to go in for radiotherapy, as surgery was not possible. But not any more. Doctors at Advanced Research and Medicare Institute removed Ladla’s larynx and pharynx, and reconstructed his foodpipe with a free flap from the forearm. Indirect laryngoscopic examinations had earlier revealed a large growth involving the larynx, pharynx, respiratory pipe and the foodpipe. The cancer was detected after direct laryngoscopic biopsy, and a CT scan found that it was locally advanced, affecting both pipes. “Since the cancer was locally advanced, we had to remove both the pipes. Through micro-vascular reconstruction, pharynx was repaired and the patient is doing well,” said oncologist Subhankar Deb, who along with a team of other doctors, performed the 10-hour surgery. The carotid artery and internal jugular vein of the neck was rejoined with the vein and artery of the flap, thus maintaining nutrition and blood supply to it. “Had there not been such a reconstruction, the flap would not have survived,” Deb said. Tracheotomy was done to enable the patient to breathe. “We had planned to reconstruct the pharynx with a flap from the intestine. Since a wall of the pharynx could be retained, the flap was taken from the [...]

2009-03-25T18:02:26-07:00December, 2004|Archive|

Throat cancer treatment saves voices

12/24/2004 Ivanhoe Newswire The Triangle and Fayetteville A promising new option for people with throat cancer is combining surgery and laser treatment to save patients' voices. The benefactors are people like Dolly Sigel, who used to be a speech therapist. Ironically, she was recently faced with the possibility of losing her voice. "I was devastated," Sigel said, recalling the diagnosis of a cancerous tumor on her right vocal chord. "I couldn't believe that this was happening to me." One treatment option was seven weeks of radiation, but Dolly was afraid it might affect her voice. Luckily, she came across a doctor who sought a superior remedy. "Dr. Strome was doing a new procedure that would eliminate radiation, and there was a very good chance that voice quality would be retained," Sigel said. In the new procedure, Otolaryngologist Marshall Strome, of the Cleveland Clinic in Ohio, uses a laser to remove the tumor and then uses cryosurgery to freeze any remaining tissue. "What the freezing does, at least to our knowledge at this point in time, is enables that scar tissue to be less dense, more pliable and gives us a better voice quality," he said. Strome explained that key to removing a tumor is to leave as much normal tissue as possible. He says cryosurgery does just that. After Sigel's treatment, her voice returned almost immediately. "I'm very optimistic," she said. "I just think it's terrific. Without a doubt, with no question, this has been a blessing." And it is [...]

2009-03-25T18:01:49-07:00December, 2004|Archive|

Oral Squamous Cell Carcinoma; Gene expression profile of invasive tumors characterized

12/24/2004 staff Genomics & Genetics Weekly, Dec. 17, 2004 Gene expression patterns associated with invasive oral squamous cell tumors have been identified. "There are limited studies attempting to correlate the expression changes in oral squamous cell carcinoma with clinically relevant variables," scientists in the United States noted. In their study, G.A. Toruner and coauthors at the University of Medicine and Dentistry of New Jersey "determined the gene expression profile of 16 tumor and 4 normal tissues from 16 patients by means of Affymetrix Hu133A GeneChips." "The hybridized RNA was isolated from cells obtained with laser capture microdissection, then was amplified and labeled using T7 polymerase-based in vitro transcription," the investigators explained. "The expression of 53 genes was found to differ significantly (33 upregulated, 20 downregulated) in normal versus tumor tissues under two independent statistical methods." "The expression changes in four selected genes (LGALS1, MMP1, LAGY and KRT4) were confirmed with reverse transcriptase polymerase chain reaction," according to the report. "Two-dimensional hierarchical clustering of the 53 genes resulted in the samples clustering according to the extent of tumor infiltration: normal epithelial tissue, tumors less than or equal to4 cm in dimension, and tumors more than 4 cm in dimension (p=0.0014)." "The same pattern of clustering was also observed for the 20 downregulated genes. We did not observe any associations with lymph node metastasis (p=0.097)," the researchers concluded.

2009-03-25T18:01:14-07:00December, 2004|Archive|
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