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Chemopreventative effects of a topically applied black raspberry gel on oral premalignant tumors.

Chemoprevention, Naturally: Findings on Plant-derived Cancer Medicines

December 6, 2007
PHILADELPHIA – The next cancer-fighting therapeutic could be growing in your garden, according to research presented today, at the American Association for Cancer Research’s Sixth Annual International Conference on Frontiers in Cancer Prevention Research, being held from December 5 to 8 in Philadelphia, Pennsylvania.

For example, a black raspberry-based gel might offer a means of stopping oral lesions from turning into a particularly dangerous and disfiguring form of cancer. And new studies show that cancer prevention might come in drinkable form: green tea extract, a powerful antioxidant, shows efficacy against colorectal cancer; and a new berry-rich beverage, made from a combination of known plant-based antioxidants, could prevent or slow the growth of prostate cancer.
Chemopreventative effects of a topically applied black raspberry gel on oral premalignant tumors. Abstract no. B35:

Oral squamous cell carcinoma is a deadly cancer that, even when treated successfully, often leaves patients permanently disfigured. Other than radical surgery, there are few known treatments. Researchers at Ohio State University, however, report a Phase I/II trial demonstrating that a gel made from black raspberries shows promise in preventing or slowing the malignant transformation of precancerous oral lesions.

“Black raspberries are full of anthocyanins, potent antioxidants that give the berries their rich, dark color, and our findings show these compounds have a role in silencing cancerous cells,” said Susan Mallery, D.D.S., Ph.D., professor in the Department of Oral Maxillofacial Surgery and Pathology at Ohio State University’s College of Dentistry. “This gel appears to be a valid means of delivering anthocyanins and other cancer-preventing compounds directly to precancerous cells, since it slowed or reduced lesion progression in about two-thirds of study participants.”

According to American Cancer Society statistics, oral cancer is one of the deadliest of all cancers, with about 35,000 new cases each year in the United States and 7,500 deaths annually. These cancers generally begin as small, often unnoticed, lesions inside the mouth. “More than a third of untreated precancerous oral lesions will undergo malignant transformation into squamous cell cancer, but we do not have the capability to predict which lesions will progress,” Mallery said.

The National Cancer Institute-funded trial included 30 participants, 20 of whom had identifiable precancerous lesions, and 10 normal controls. Each of the participants was instructed to gently dry the lesion sites (or a pre-selected control site for the normal participants) and rub the gel into the area four times a day, once after each meal and at bedtime.

After six weeks, about 35 percent of the trial participants’ lesions showed an improvement in their microscopic diagnosis, while another 45 percent showed that their lesions had stabilized. About 20 percent showed an increase in their lesional microscopic diagnoses. Importantly, none of the participants experienced any side effects from the gel.

“The trial was designed to test the safety of the gel and detect any possible toxicity, but the next obvious step is a multicenter, double-blind, placebo-controlled Phase II study,” Mallery said. “Such a study would enable us to determine that the black raspberries are the active factor and not just the gel base or the act of drying and rubbing the lesions.”

The researchers also collected cell samples from the lesion sites of each participant before and after treatment in order to study the genetics and biology of the lesions. The majority of patients with precancerous lesions at the start of the trial showed elevated levels of COX-2 and iNOS, two proteins closely correlated with inflammation and malignant progression. Following treatment, Mallery says, levels of those proteins in the treated lesional epithelial cells decreased dramatically.

Mallery and her colleagues also examined samples for three tumor suppressor genes in order to determine what researchers call “loss of heterozygosity,” whether or not a cancer cell has lost one of its two copies of the gene. Such loss greatly increases a cell’s chances of losing the benefit of the tumor suppressor genes due to a second mutation or gene silencing event. Following the trial, the researchers noted that many lesions returned to normal, retaining both copies of each tumor suppressor gene. “We speculate that the chemopreventive compounds in black raspberries assist in modulating cell growth by promoting programmed cell death or terminal differentiation, two mechanisms that help “reeducate” precancerous cells,” Mallery said.

“Oral cancer is a debilitating disease and there is a desperate need for early detection and management of precancerous lesions,” Mallery said. “While screening can help detect the disease early – and survival rates are definitely improved the earlier the disease is caught – many of these precancerous lesions recur despite complete surgical removal. There are currently no effective chemopreventive treatments which could conceivably serve as either adjunctive or alternative approaches to surgery.”

According to Mallery, the development of black raspberries as potential cancer-fighters is the result of decades of research into identification of naturally derived chemopreventive compounds by Ohio State researcher Gary D. Stoner, Ph.D., an emeritus professor at Ohio State University’s College of Medicine and Public Health. Clinical studies stemming from his research are currently underway for oral, esophageal and colorectal cancer.

The gel looks deceptively like black raspberry jam, but it certainly does not taste like something you would want to spread on toast, Mallery says. The bioadhesive gel, which contains 10 percent freeze dried black raspberries, is devoid of many of the tasty sugars found in native berries.

The black raspberry gel was manufactured by the University of Kentucky’s Good Manufacturing Production (GMP) facility. NanoMed Pharmaceuticals is partnering with OSU investigators Mallery, Stoner and Peter E. Larsen D.D.S. and Russell J. Mumper, Ph.D., of the University of North Carolina, in product development.

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The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world’s oldest and largest professional organization dedicated to advancing cancer research. The membership includes nearly 26,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

American Association for Cancer Research. Found at: .

With Soaring R&D Costs and a Dearth of Blockbuster Drugs, Nanotechnology could yet Prove to be the Saviour of the Pharmaceutical Industry

(January 29, 2007) With Soaring R&D Costs and a Dearth of Blockbuster Drugs, Nanotechnology could yet Prove to be the Saviour of the Pharmaceutical Industry

Mumper to Recieve AAPs Drug Delivery Systems Award

Monday, October 09, 2006 – Russ Mumper, Ph.D., associate professor and vice chair of the University of Kentucky Department of Pharmaceutical Sciences at the UK College of Pharmacy, will be awarded the 2006 American Association of Pharmaceutical Scientists (AAPS) Lipids-Based Drug Delivery Systems Award sponsored by Gattefosse during the upcoming AAPS meeting in San Antonio Oct. 29-Nov. 2. The award recognizes outstanding research, pertaining to lipids and their role in drug delivery. <

Jay Named AAPS Fellow

Monday, October 09, 2006 – Michael Jay, Ph.D., professor of pharmaceutical sciences and director of the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky College of Pharmacy, will be conferred as Fellow of the American Association of Pharmaceutical Scientists (AAPS) at the organization’s annual meeting in San Antonio, Oct. 29 – Nov. 2.

NanoMed Pharma Moves To Kalamazoo, Mich. With Series A

VENUTREWIRE

Kalamazoo, Mich. (Thursday, July 6, 2006) — NanoMed Pharmaceuticals Inc., a developer of a nanoparticle manufacturing technology for treating patients undergoing chemotherapy, said that it has closed on a Series A preferred round of venture financing.

The sole investor in the round was the Southwest Michigan First (SWMF) Life Science Venture Fund, which invests in life science companies in the Kalamazoo, Mich. area.

With the funding, NanoMed will move its headquarters from Lexington, Ky. to the Michigan Technical Education Center in Kalamazoo, Mich. The company’s laboratories will be located in the Advanced Science & Technology Commercialization Center at the University of Kentucky.

NanoMed Pharmaceuticdals Profiled in Windhover’s “Start-Up”

(June, 2006)NanoMed Phermaceuticals Profiled in Windhover’s “Start-Up”

Nanoparticles Overcome Anticancer Drug Resistance

(June 12, 2006) Too often, chemotherapy fails to cure cancer because some tumor cells develop resistance to multiple anticancer drugs. In most cases, resistance develops when cancer cells begin expressing a protein, known as p-glycoprotein, that is capable of pumping anticancer drugs out of a cell as quickly as they cross through the cell’s outer membrane. New research from the University of Kentucky shows that nanoparticles may be able to get anticancer drugs into cells without triggering the p-glycoprotein pump.

NanoMed Pharmaceuticals Founder Work Cited by NCI Alliance for Nanotechnology in Cancer

(June 12, 2006) Too often, chemotherapy fails to cure cancer because some tumor cells develop resistance to multiple anticancer drugs. In most cases, resistance develops when cancer cells begin expressing a protein, known as p-glycoprotein, that is capable of pumping anticancer drugs out of a cell as quickly as they cross through the cell’s outer membrane. New research from the University of Kentucky shows that nanoparticles may be able to get anticancer drugs into cells without triggering the p-glycoprotein pump.

NanoMed Pharmaceuticals Receives Option to Exlusive License To Novel Product for Oral Cancer Chemoprevention

Phase I/Ia Study To Be Conducted at The Ohio State University’s College of Dentistry and the James Cancer Hospital and Solove Research Institute
LEXINGTON, KY AND KALAMAZOO, MI (December 13, 2005) – NanoMed Pharmaceuticals, Inc. today announced that, under an Inter-institutional Agreement with The Ohio State University, the University of Kentucky Research Foundation has granted the company an option for an exclusive license to a novel Bioadhesive Berry Gel for the chemoprevention and treatment of oral epithelial dysplasia – the precancerous lesions that can develop into oral squamous cell carcinoma (SCC). Despite focused efforts to improve therapy, five-year survival rates for patients with advanced stage SCC remain discouragingly low. Of the estimated 30,000 newly diagnosed cases of oral cancer in the U.S. each year, only half of those diagnosed will be alive in 5 years. Worldwide the diagnoses of head and neck cancer are much greater, with over 350,000 to 400,000 new cases being found each year.

NanoMed Pharmaceuticals Founder Cited by National Nanotechnology Coordination Office

(November 17, 2006) NanoMed Pharmaceuticals Founder Cited by National Nanotechnology Coordination Office

Testimony to the House Committee on Science

(November 17, 2005) Testimony to the House Committee on Science

Nanoparticles Referenced by NCI as Non-Toxic to Blood Cells

Common Nanoparticle Shown to Be Non-toxic to Blood Cells

(October 3, 2005) Though many kinds of nanoparticles, loaded with a variety of drugs and imaging agents, are making their way toward the clinic, questions about nanoparticle toxicity remain to be answered. Given that the majority of nanoparticles are intended to travel to tumors through the bloodstream, the effects of nanoparticles on blood cells are of particular concern to those developing nanoparticle-based therapeutic and imaging agents. Now, a series of experiments by researchers at the University of Kentucky have found no ill effects when blood cells are exposed to one common type of nanoparticle.

New Vaccine Technologies Carry and Deliver

(May 2, 2005) New Vaccine Technologies Carry and Deliver

NanoMed Pharmaceuticals Founder Co-Develops Novel Gel for Oral Chmoprevention

(April 9, 2005) NanoMed Pharmaceuticals Founder Co-Develops Novel Gel for Oral Chmoprevention

Good Things in Small Packages: Nanotech advances are producing mega-results in drug delivery

(July 2004) Good Things in Small Packages: Nanotech advances are producing mega-results in drug delivery

CRS Spotlight on NanoMed

(2003) CRS Spotlight on NanoMe