The Austin, Texas-based corporation submitted Advexin® for priority review by the US Food and Drug Administration (FDA) on Monday, June 30, 2008. Advexin® is a gene therapy that’s been under development for 14 years and the first gene-based drug to get this far in the US drug approval process.

Introgen Therapeutics, which is partly owned by MD Anderson Cancer Center researcher Dr Jack Roth and the University of Texas, is also seeking approval to market the drug in Europe.

Advexin® uses deactivated cold viruses to insert p53 tumor suppressor genes into cancer cells. It is designed to restore p53 function in patients who have a low levels of the p53 gene so healthy cells can be replenished while malignant cells die. The company’s clinical trials on Advexin® indicated two-thirds of patients with difficult to treat head and neck cancers may be potential candidates for the treatment.

If the FDA accepts the gene therapy for priority review – and if the treatment meets drug safety standards – approval could come in as little as six months. Without priority consideration, the FDA’s decision would likely take closer to a year. Either way, this application is going to be closely tracked by cancer patients, healthcare providers and pharmaceutical industry insiders who are curious about the potential of gene-based treatments. As one securities analyst said,

“It’s a major milestone for gene therapy, because it’s a first-in-class drug.”

Stephen Dunn
Dawson James Securities

Introgen is also evaluating Advexin® for the treatment of certain breast and lung cancers, but this week’s FDA application is only for the treatment of recurrent head and neck cancer. Approximately 40,000 people are diagnosed with head, neck and throat cancers in the US each year.

If you’re a patient in the US who’d like to learn more about head and neck cancer treatments, you can visit the National Cancer Institute’s Head and Neck Cancer page.

Source: Austin American-Statesman

Related Links: WebMD.com; seekingalpha.com

Technorati Tags: laryngeal cancer; oncology; oral cancer; oropharyngeal carcinoma; personalized medicine and pharmacogenomics; targeted therapies; orphan drugs

Grant Achatz is the head chef at Alinea, an upscale Chicago restaurant recognized as the best in the country by Gourmet Magazine. He’s also a tongue cancer survivor.

Last July, Achatz, an otherwise healthy non-smoker, was diagnosed with advanced oral squamous cell carcinoma. The disease had already spread through approximately 70 percent of his tongue and he was classified Stage IV.

After consulting several top oncologists, the 34-year-old father was faced with a difficult choice: have three-quarters of his tongue cut out or try an alternative treatment approach being practiced at the University of Chicago Medical Center. He knew the alternative method would be painful, but it might preserve his tongue so he decided to give it a try.

The alternative method (called combination therapy) changes the standard order of treatment from surgery, radiation and chemotherapy to chemotherapy, radiation and possible surgery later. This approach is designed to shrink or possibly eliminate malignant tumors and lesions prior to performing surgery so more of an organ’s tissue can be spared.

The chef’s case is being handled by a medical team which specializes in trying to save organs rather than removing them. This team of doctors includes oncologist Everett Vokes, head-and-neck surgeon Elizabeth Blair, and radiologist Daniel Haraf. As one members of the team said,

“We were offering him six months of pure misery. But we were also telling him that there was a 70 percent chance that he would be cured.”

Daniel J. Haraf, MD
Medical Director, Radiation Oncology
University of Chicago Medical Center

Achatz did experienced serious side effects which included loss of appetite, difficulty swallowing, hair loss, and painful skin burns, but he remained determined. He even created exciting new recipes while he was getting chemotherapy infusions, and his friend sous-chef Jeff Picus helped out by tasting them with his own expert palate.

The chef’s choice appears to have paid off – he’s been cancer-free for five months and his sense of taste is starting to return.

If you’d like additional information on oral/mouth cancers, you can get it on the National Cancer Institute and the Oral Cancer Foundation web sites.

Source: Associated Press Article from FOX News

Related Links: The New Yorker; NapaValleyRegister.com; The American Dental Association; ImTooYoungForThis.org

Technorati Tags: head and neck cancer; rare diseases; glossectomy; second opinions

The pulsed Potassium-Titanyl-Phosphate laser being used at MGH is an angiolytic laser that uses wavelengths of laser light to specifically target diseased cells without damaging healthy vocal cord tissue.

A team led by Dr Steven Zeitels of the MGH Center for Laryngeal Surgery and Voice Rehabilitation began applying pulsed lasers to early vocal cord cancers more than five years ago. Similar technology was originally applied to the removal of port-wine stains by dermatologist R. Rox Anderson, MD, the director of the MGH Wellman Center of Photomedicine, who collaborated closely with Dr Zeitels.

The first 22 patients who’ve received MGH’s pulsed laser treatments for vocal cord cancer are cancer-free up to 5 years after treatment without surgical removal of vocal cord tissue or loss of voice quality, although some have required multiple laser treatments. Dr Zeitels estimates that 90 percent of early vocal cord cancer patients would be candidates for pulsed laser treatment. As he said about the technology,

“It has greatly enhanced the precision by which we can perform many procedures for chronic laryngeal diseases, both in the operating room, accompanied by the surgical microscope, and in the office.”

Steven M. Zeitels, MD, FACS
Director, Center for Laryngeal Surgery and Voice Rehabilitation, MGH

Dr Zeitels gained previous notoriety while treating vocal conditions in singers Steven Tyler of the band Aerosmith and Julie Andrews of the film The Sound of Music.

MGH reported results from their research at the annual meeting of the American Broncho-Esophagological Association and their findings are scheduled for publication in a supplemental edition of the Annals of Otology, Rhinology and Laryngology.

Source: EurekAlert.org

Related Links: HealthDay News; The New York Times

Technorati Tags: laryngeal cancer; head and neck cancer; throat cancer; pulsed-KTP; cordectomy

Lori’s husband died in 2007 of neck cancer at the age of 49. Lori says that neither she nor Bobby gave any thought to annual screenings before his diagnosis at 47. They also had no idea that more than 7,000 Americans die of head and neck cancers annually.

Bobby’s cancer was discovered when he went to see a dentist to get a wisdom tooth removed.

But now she knows early detection plays a crucial role in cancer survival and she’s spreading the word at locations where there’s plenty of people to listen to her message: NASCAR races. While she travels the circuit she speaks to race fans and visits surrounding clinics encouraging adults to get screened for head and neck cancers every year, raising awareness about the symptoms, and reassuring the reluctant that detection is easy and painless. At the Kansas Speedway, health professionals from the University of Kansas Hospital offered free cancer screenings before the start of the race. As Lori explains,

“At a racetrack, we have a captive audience of 80,000 people. If we can reach a third of them, maybe it can make a difference.”

Lori Hamilton
Head and Neck Cancer Awareness Advocate

A study conducted by Johns Hopkins University found HPV-related oral cancers alone nearly doubled between 1973 and 2004. If you’d like to learn more about head and neck cancers you can visit Cancer.Net, a web site containing information from the American Society of Clinical Oncology.

Source: CNN

Related Links: wsbt.com; KansasCity.com; NASCAR.com; The Yul Brynner Head and Neck Cancer Foundation; Mouth Cancer Foundation

Related Video: Lori Hamilton, Wife of NASCAR Legend Bobby Hamilton, Urges from myspacetv.com

Technorati Tags: cancer advocacy; otolaryngology; squamous cell carcinoma

Glioblastoma is a rare form of brain cancer with a poor survival rate. STAT3 inhibitors are one of the few therapies available to treat the disease, but Harvard’s study indicates the patient’s genetic profile determines whether STAT3 genes act as oncogenes that promote tumor development or suppressors that work to stop cancer.

To arrive at their findings, researchers from Harvard and the Dana-Farber Cancer Institute studied astrocytes in mice. Their investigation revealed mutations in two other genes, EGFR and PTEN, affected the function of STAT3 thereby determining whether it kept cancerous cells in check or helped their formation. Specifically, when EGFR mutated and interacted with STAT3, it turned STAT3 into an oncogene, but when PTEN mutated it transformed STAT3 into a tumor suppressor. The scientists later confirmed their surprising results in human glioblastoma tumors.

The discovery has important implications for glioblastoma patients because STAT3 has long been believed to cause the cancer. As the study’s senior author explained,

“This discovery lays the foundation for a more tailored therapeutic intervention. And that’s really important. You can’t just go blindly treating people by inhibiting STAT3.”

Azad Bonni, MD, PhD
Associate Professor of Pathology, Harvard Medical School

The team’s findings could impact studies on more common cancers as well — STAT3 has also been implicated in some breast and prostate cancers.

If you’d like to learn more, results of the study are published in the February 7, 2008, online edition of Genes and Development.

Source: Harvard Medicine News Alert

Related Links: National Brain Tumor Foundation; Society for Neuroscience; biologynews.net

Related Podcast: Human U87MG Cells Transduced with a Dominant Negative p53 (Tp53) Adenovirus Construct Undergo Radiation-Induced Mitotic Catastrophe from the Radiation Research Society

Technorati Tags: glioma; neuro-oncology; neurology; Stewart Trust of Washington, DC; Armenise-Harvard Foundation; Carolyn and Peter Lynch Research Fund; Boston, MA

Loyola’s investigation, which included over 3800 patients, concluded that long term cure rates were equivalent using both therapies but, radiation treatment significantly reduced the risk of developing a second laryngeal cancer later on.

The scientists attribute the difference in recurrence rates to a new concept which Dr Gopal Sachdeva, the study’s lead investigator, is referring to as “field sterilization.” As he explained,

“In the case of larynx cancer, radiation treats a larger area, essentially the entire voice box. Surgery however usually just addresses the site of the tumor. Thus, radiation likely eliminates microscopic areas of precancerous changes in the field that if left untreated can progress to new second cancers.”

Gopal Sachdeva, MD
Radiation Oncology, Loyola University Medical Center

Dr Sachdeva is currently conducting other studies on second cancers in cancer survivors. As a group, second cancers are now the sixth most common cancer in the United States after skin, prostate, breast, lung and colorectal cancers. Statistics indicate more than 10 percent of the 10.5 million cancer survivors alive today will develop a second cancer during their lifetime.

Findings from the study were presented at the 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology.

Source: oralcancerfoundation.org

Related Links: National Institute on Deafness and Other Communication Disorders; University of Maryland Greenebaum Cancer Center; Mouth Cancer Foundation (UK); Medical News TODAY; UCSD

Related Video: Endoscopic Partial Laryngectomy by Our Lady of the Lake Regional Medical Center from OR-Live.com

Related Audio: Local Research from ASTRO Convention (Sachdeva) from Radio News Source by News Generation, Inc

Tags: throat cancer; laryngectomy; Illinois; Los Angeles Convention Center

The drugs, known as Erythropoiesis Stimulating Agents or ESAs, contain genetically engineered proteins used to increase red blood cell counts in many patients with cancer or chronic kidney failure.

The new warnings caution that ESA dosages administered when hemoglobin levels exceed 12 grams per deciliter have been linked to increased tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid, or non-small cell lung cancer. ESA dosing outside the range being recommended by the FDA has also been shown to increase the risk of stroke, heart attack, heart failure, and death in patients with chronic kidney failure.

ESAs are routinely dispensed to help patients combat the effects of acute anemia and avoid the risk and inconvenience of blood transfusions. The popular drugs are marketed under the brand names Aranesp®, Epogen® and Procrit®.

While the drugs are still approved for continued use, physicians are cautioned to evaluate each patient on a case-by-case basis to ensure ESA use is appropriate.

Source: washingtonpost.com

Related Links: Amgen (NASDAQ: AMGN); Ortho Biotech Products, LP; PharmaLive.com; Centers for Medicare and Medicaid Services; CNNMoney.com

Related Video: Alice on Anemia from Understanding Cancer TV

Tags: drug safety; oncology; darbepoetin alfa; epoetin alfa; pharmacology; prescription medications

The addition of docetaxel to the cisplatin and fluorouracil combination typically administered increased survival rates in both studies and more than doubled the average overall survival in one of the groups.

Both studies, one based in the U.S. and the other in Europe, were comprised of patients in stage III or IV of the disease. The U.S. trial included 501 patients with resectable and unresectable head and neck tumors while the European study contained 358 patients, all with inoperable tumors.

In addition to better survival rates, both groups experienced slightly fewer toxic side effects because oncologists administered less fluorouracil once docetaxel was added. Including the three-drug induction chemotherapy prior to chemoradiotherapy added about three months to the treatment process.

Both studies received funding support from the docetaxel’s manufacturer, Sanofi-Aventis (NYSE: SNY).

More research is needed before experts can determine whether the induction therapy plus chemoradiotherapy (chemotherapy and radiation combined) is more effective than chemoradiotherapy done alone. Still, researchers are enthusiastic about the results of the research to date. As the lead author of the US study summed it up,

“There was a 30 percent reduction in mortality with less toxicity. This is a wonderful step forward for patients.”

Dr Marshall R. Posner
Medical Director of the Head and Neck Oncology Program
Dana-Farber Cancer Institute

Source: HealthDay

Related Links: CNNMoney.com; oralcancerfoundation.org

Related Podcast: Red Door Communications Podcast from the Mouth Cancer Foundation

Tags: Boston; 5FU; Taxotere

Because Devil groups lack genetic diversity, their bodies don’t launch an immune response to combat tumors. The disease progresses rapidly, resulting in disfiguring growths on the animal’s face and neck which prevent it from feeding.

Research conducted by University of Sydney, the University of Tasmania, the Australian Museum and the Tasmanian government revealed that the cancer in every animal tested originated from a single cell line and was spread by biting. As one researcher explained,

“Essentially, there are no natural barriers to the spread of the disease, so affected individuals must be removed from the populations to stop disease transmission.”

Katherine Belov
University of Sydney School of Veterinary Science

Results of the study have been published online in the Proceedings of the National Academy of Sciences of the United States of America.

Source: Reuters Science

Related Links: National Geographic News; tassiedevil.com; University of Sydney News

Related Podcasts: The Science Behind the Damage of Inbreeding from NPR

Tags: endangered species; carnivores; contagious cancers; veterinary medicine; Genetics and Public Policy Center

University of Texas researchers have developed a simple and inexpensive test which dentists can use to detect cancerous cells in the mouth in as little as 10 minutes.

A small acrylic testing device strains cells taken from the patient’s mouth and floods them with a fluorescent solution that sticks to proteins known to be biomarkers for cancer. If the proteins are present, they omit an intense green glow that can easily be detected under a fluorescence microscope. The developer of the new machine, John McDevitt, envisions it being standard equipment in all dental offices and believes it could also be adapted to test for other forms of the disease, such as cervical cancer.

Oral cancer is relatively uncommon, but thousands of people die of the disease each year because it often isn’t detected until it has progressed into the advanced stages.

If you’re interested in hearing more about oral cancer, listen to this broadcast from University of Washington Television.

Source: MIT’s Technology Review

Related Links: NIDCR; Mouth Cancer Foundation; abc NEWS

Spanish Links: Oral Cancer Information from NCI

Tags: Austin; San Antonio; UT Health Science Center; microfluidics