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Novel lipoplex nanoparticle to be used in 1st human trial treating advanced solid cancer

Novel lipoplex nanoparticle to be used in 1st human trial treating advanced solid cancer

August 25, 2005

Holiday In Wales Washington D.C. - The first clinical trial of a biologic nanoparticle designed to give back to cancer patients the tumor-busting gene they have lost is expected to start in September at Georgetown University Medical Center.

(HealthDay News) - Here are the latest clinical trials, courtesy of Breast Cancer This is a clinical study to test safety and efficacy of an experimental drug designed to treat advanced breast cancer. Those who may qualify for the trial are women at least 18 years old who have metastatic or locally unresectable advanced breast cancer and have not had other cancers in the last 3 years (excluding basal or squamous cell skin cancer, or cervical cancer) or cancer that has spread to the brain. feeding.

Holiday Wales The phase I clinical study will enroll 20 patients with advanced solid cancers (including most common tumor types), and is the culmination of more than a decade of work by a team of researchers led by Professor Esther H. Chang, Ph.D. at the Lombardi Comprehensive Cancer Center.

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Cottage Holiday In Wales Their research has led to development of a tiny structure - measuring a millionth of an inch across - that resembles a virus particle that can penetrate deeply into the tumor and move efficiently into cells. The device is a "liposome" - a microscopic globule made of lipids - that is spiked on the outside with antibody molecules that will seek out, bind to, and then enter cancer cells including metastases wherever they hide in the body. These molecules bind to the receptor for transferrin that is present in high numbers on cancer cells.

Vigabatrin is currently being tested on humans for cocaine and methamphetamine addiction. There are plans to conduct human trials using the drug to treat alcoholism and binge drinking.

Caravan Holiday In Wales Once inside, the nanoparticle, which the researchers call a "immunolipoplex," will deliver its payload - the p53 gene whose protein helps to signal cells to self-destruct when they have the kind of genetic damage characterized by cancer and by cancer therapies.

Manish Aghi, M.D., Ph.D., of the Massachusetts General Hospital in Boston, and colleagues paired temozolomide with an oncolytic, or cancer killing, genetically engineered form of the herpes simplex virus called G207. They tested both agents together and separately in cancer cells and in mice with gliomas. Their laboratory studies on human cancer cells found that the virus and the drug act synergistically in cancer cells to promote cell death. Mice with brain gliomas treated with both the virus and the drug survived more than twice as long as those treated with either agent alone.

Camping Holiday Wales More than half of all cancer patients have cancer cells that have lost normal functioning of the p53 gene, so-called "guardian of the genome," and the Georgetown researchers believe that restoring the gene will improve the tumor-killing ability of traditional treatments.

However, the vast majority of lung cancer patients are diagnosed when the disease is more advanced than stage I. In a trial studying patients with more advanced disease, supplementation with 300, 000 IU per day for one year followed by 150, 000 IU per day for another year did not reduce lung cancer recurrences.60 Moreover, another trial that studied smokers and workers exposed to asbestos found that daily supplementation with 25, 000 IU of vitamin A plus 50, 000 IU of synthetic carotene (which can act as a vitamin A precursor in the body) for four years led to a slight increase in the risk of getting lung cancer compared to no treatment.61.

Accommodation Holiday Wales "We are excited about the promise this nanoparticle has shown in animal tumor models, and are anxious to offer it to patients," said Chang, Professor in the Department of Oncology and Co-director of the Molecular Targets & Developmental Therapeutics Program at Georgetown.

Holiday Last Minute Wales The federal Food and Drug Administration granted approval for the trial to begin in late July. The work is being sponsored by grants from the National Institutes of Health and private foundations. Additional support comes from SynerGene Therapeutics, a biotech research firm with which Chang collaborates.

Catering Holiday Self Wales John Marshall, M.D., Director of Developmental Therapeutics and GI Oncology at Georgetown, will serve as the trial's principal investigator.

Holiday Wales Walking The researchers believe that immunolipoplex represents an advance over the viral "vectors" that have been used to deliver gene therapy, because these liposomes do not produce the kinds of immunologic response seen when disabled viruses are used to carry the payload. They also say that the nanoparticle is of a small uniform size and consistency, and has been proven to work in animals bearing tumor.

Family Holiday Wales In preclinical research, Chang and long-term research colleague Kathleen Pirollo, Ph.D. have found that these nanoparticles substantially improve the tumor-fighting power of both chemotherapy and radiation therapy. These agents work synergistically with traditional therapies because the newly restored p53 protein helps push cancer cells that are now damaged to self-destruct.

Holiday Riding Wales "We believe this approach will make it difficult for the cancer cells to become resistant to therapy," Chang said. "As a result, cancers treated with these liposomal formulations should be less likely to recur after therapy is complete."

Adventure Holiday Wales For example, use of these p53-loaded liposomes in combination with radiation therapy eliminated prostate and head and neck tumors in mice, which then survived cancer-free for more than 200 days - until they all died of old age. Similar promising results were seen when the nanoparticles were combined with chemotherapy to treat animal models of melanoma and aggressive breast cancer.

Holiday Park South Wales Among the solid tumors approved for testing in the clinical trial are head and neck, prostate, pancreatic, breast, bladder, colon, cervical, brain, melanoma, liver and lung cancers.

Cottage Holiday Wales Georgetown University Medical Center

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