Drug research heavy in region

Mercer Business, Feb 01, 1997 by Fischer, Dorothy

Cancer is a most formidable enemy, an adversary whose very name is fearsome. Many of the strategies and weapons to be used in the war against its relentless onslaughts are being developed within Mercer County at medical research and development facilities.

Some have already gone to the front where they are clashing with the dreaded disease head-on. Cytogen Corporation of Princeton has two FDA-approved products on the market, both imaging agents.

OncoScint CR/OV is antibody-based and is used in the detection of colorectal and ovarian cancers. According to the American Cancer Society, these will least 165,000 Americans this year, a grim number to add to the total of 1,361,000 victims already diagnosed.

This product seeks out and attaches to a particular antigen expressed on the surface of these malignant tumors. Attached to the antibody is an imaging isotope. Externally, a gamma camera scans the patient's torso and detects and records the gamma rays from the isotope. This results in an image that specifies the location and extent of the cancer.

Marketed since 1993, OncoScint CR/ OV detects disease that is beyond the scope of standard diagnostic modalities. It plays a major role in diagnosing new patients, as well as those with suspected recurrences. Thus, it contributes to earlier identification and also provides a more informed assessment for future treatments.

Cytogen's second commercial product, ProstaScint, is also a diagnostic imaging agent utilizing monoclonal antibodies. Its target is prostate cancer, its weapon a more accurate detection of extent and locations. so an antibody, this product seeks out and attaches to a particular antigen on the surface of malignant prostate tumors.

The company was given FDA license to market ProstaScint in October of last year after clinical studies indicated its value in identifying extra-prostatic disease, particularly in the lymph nodes, a metatastic development that often goes undetected using other available strategies. During 1996 alone, over 300,000 men were newly diagnosed with prostate cancer.

Quadramet is a Cytogen-developed therapy agent for the treatment of bone metastasis. It completed Phase III human clinical trials and was filed with the FDA in August, 1995. This radiopharmaceutical drug was developed to address the severe, chronic pain associated with cancer that spreads to the bones.

It provides effective pain management without the use of narcotics and their subsequent, negative side effects.

Cytogen's product pipeline includes five other disease fighters, designed for dealing with specific forms of cancer, and one, ALT, which is aimed at chronic hepatitis. All are in various phases of clinical testing. One is an imaging agent while the rest are therapies. A blood screening product for prostate cancer patients is in a preclinical phase.

As its name indicates, the Liposome Company, also in Princeton, focuses on liposomes, microscopic manmade lipid spheres that can be engineered to entrap drugs, thus creating new pharmaceuticals with enhanced efficiency and/ or better safety. Drawing on its expertise with both lipids and liposomes, the firm develops products to target drugs, while also utilizing lipids as new drugs.

One of its recent products is Abelcet, an antifungal treatment for those suffering from systemic fungal infections, an ominous development that can be a major threat to those with weakened immune systems. Thousands of patients have been treated with Abelcet since its United States : debut in January, 1996.

Liposome products now in clinical trial stages include TLC C-53, a liposomal prostalandin designed to treat acute inflammatory and vaso-occlusive diseases, including acute respiratory distress syndrome (ARDS), a condition resulting from major body trauma. The United States has an annual count of 150,000 ARDS victims, with a 40 percent mortality rate.

Metastatic breast cancer is the target of another Liposome product, TLC D-99, which is designed to attack tumor cells while sparing healthy tissue. It also maintains or enhances efficacy while reducing toxidity.

The company has also begun formal development programs for another cancer therapy, TLC ELL-12, which is aimed at prostate cancer and lung carcinomas. Integra Life Sciences Corporation in Plainsboro was founded in 1989 with the goal of producing a new class of medical products, designed to enable the human body to rejuvenate its own functioning tissues and organs to replace those irreversibly lost through disease, surgery or accidents.

On March 1, 1996, their efforts were rewarded with FDA approval of Integra Artificial Skin. The company is also developing other products aimed at regenerating a variety of body tissues, including articular cartilage and peripheral nerves.

These products are known as Regen eration Templates, developed to be surgically implanted to serve as temporary structures that induce regeneration of functional tissues. They are absorbed into the body during the process.

Integra artificial skin has been heralded as "a total breakthrough." Its two-layer structure includes a dermal replacement layer, a porous woven collagen fiber designed to induce better regeneration of the patient' s natural tissue. The outer layer is a removable silicone membrane that acts as a temporary epidermal layer, which holds in moisture as the healing progresses.