Cancer research turns a corner

NCI taps Cornerstone Pharmaceuticals’ nanotechnology for evaluation of anti-cancer agents

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CRANBURY, N.J.—Cornerstone Pharmaceuticals says it has entered into an agreement with the National Cancer Institute (NCI) to collaborate on research involving the company's proprietary nanotechnology. The agreement marks the first collaboration of this kind between Cornerstone and the NCI.

As part of the collaboration, Cornerstone will apply its novel lipid oil nanoemulsion to a class of anti-cancer agents developed by the NCI's Center for Cancer Research Nanobiology Program. These agents, developed within the laboratory of renowned biologist Dr. Robert Blumenthal, can be turned into toxic compounds by targeted radiation and ultrasound. Cornerstone and NCI will evaluate the potential of these combined technologies in reducing tumors.

"From Cornerstone Pharmaceutical's perspective, the U.S. National Cancer Institute, over a period of decades, has established the infrastructure to research how cells become cancerous, how to identify new drugs and treatments, models that can be used to predict what will happen in man and the ability to conduct clinical studies in accordance with U.S. FDA guidelines," says Dr. Robert Shorr, CEO of Cornerstone Pharmaceuticals. "We believe that the researchers at the National Cancer Institute are world class with some of the most innovative and exciting discoveries in cancer research emerging from their laboratories."

Shorr notes that the specific investigators with whom Cornerstone is collaborating are recognized leaders in discovering molecules that can be used independently or combined with other treatment modalities to more effectively treat tumors.
"Cornerstone sees an important aspect of the Nanobiology Program's work is the ability to improve the penetration of tumors by drugs under development," he says. "The Nanobiology Program is pioneering approaches to improve cancer drug delivery. In its collaboration with NCI, Cornerstone intends to facilitate new research that will leverage NCI resources to benefit public health. We consider it a privilege to be working shoulder to shoulder with scientists of their caliber."

Cornerstone has been able to formulate multiple types of anti-cancer compounds in Emulsiphan, its novel lipid oil nanoemulsion. Shorr points out that Emulsiphan is designed to maximize drug concentration into tumor cells thereby enhancing the anti-cancer compound's selectivity and specificity, leading to a potentially safer and more effective cancer treatment. This is of particular importance for those tumors that may be located in a site not accessible to surgical intervention. Examples include, but are not limited to, tumors of the brain, liver, pancreas and gallbladder.

Dr. Yossef Raviv, who works in the laboratory at the NCI, discovered that a class of agents may become toxic when delivered to cancer cells and activated by an external energy source.

"The NCI and Cornerstone are interested in developing a nanoemulsion platform for the delivery of hydrophobic radiation and ultrasound sensitive compounds to tumors in vivo," Shorr adds. "This is an important step forward towards achieving the dream of safe and effective cancer therapy for the most difficult to treat cancer types."

Shorr points out that many approved drugs as well as newer cancer selective agents in use or in development today are difficult to solubilize and rely on diffusion after intravenous or oral administration to reach tumor cells. Often drugs may be metabolized and cleared from the body prior to reaching their target and as cells are distal from a tumor's vasculature, it is more difficult for a drug to reach a sufficient concentration to be useful.  
While technology continues to be evaluated for increasing the concentration of drugs in a tumor mass, Shorr notes that some of these may actually inhibit the uptake of a drug into tumor cells. According to Shorr, there are several advantages to Cornerstone's cancer selective nanotechnology platform, Emulsliphan.

"In Cornerstone's experience, some of the most useful anticancer agents are also the most difficult to dissolve and deliver to a tumor in a useful form," he says. "The scientific literature demonstrates that the majority of the active ingredients in chemotherapies administered to treat tumors never make it to the target within the cancer cell. Cornerstone's Emulsiphan drug delivery technology aims to overcome these challenges so that increasing the required effective dose doesn't deliver treatment at the expense of risking a patient's safety."

An entire formulation science has arisen around the solubilization of poorly soluble drugs, Shorr adds.

"How to make drugs become more specifically delivered to cancer cells and the site of their intended target has also been the subject of a tremendous worldwide research effort," he notes. "Aside from having a drug specifically delivered to the diseased cell and its intended target, there is the additional challenge of keeping drugs away from healthy cells and tissues that might otherwise be affected, to prevent unwanted side effects and morbidity. The challenge is to minimize the side effects of cancer chemotherapy and maximize drug tolerance and positive outcomes from cancer chemotherapy treatments."

Numerous delivery approaches are being actively explored by other players, as well as Cornerstone. In addition, delivery approaches have complicated manufacturing schemes that are difficult to bring to commercial scale or result in products that have limited shelf-life and therefore utility. Some delivery approaches also contribute to unwanted side effects.

"Many delivery approaches require chemical changes to be made to the drug in order to be compatible with the delivery technology," Shorr says. "Others help to make drugs more soluble, but do not contribute to more specific delivery."

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