The Industry Insider: March 2007

By Prachi Patel
Published: Tuesday, Aug 17, 2010

FDA OKs Ikonisys’ Bladder Cancer Test

Ikonisys Inc., a New Haven, Conn.-based developer of automated cell-based diagnostic products, announced in January that the FDA cleared the company’s bladder cancer diagnostic test oncoFISH™ Bladder for marketing in the US. The diagnostic application, together with the company’s robotic digital microscopy platform, aids in the detection of bladder cancer by  automated testing of cells found in urine specimens.

Ikonisys’ products automate a time-consuming laboratory technique called fluorescence in situ hybridization (FISH), which is used routinely to identify chromosomal abnormalities associated with various diseases. The oncoFISH bladder application looks for abnormalities in chromosomes 3, 7, 9, and 17 in the cells found in urine sediment. The goal of the test is initial diagnosis of bladder cancer in patients with hematuria (blood in the urine) and monitoring for tumor recurrence in patients who have been diagnosed with bladder cancer.

Petros Tsipouras, the Chariman and CEO of Ikonisys said that “oncoFISH bladder is expected to significantly reduce the time required to process test results while improving the accuracy of bladder cancer diagnosis.”

Good News From China for Peregrine

string of important announcements have recently come from Tustin, CA-based Peregrine Pharmaceuticals, Inc., a biopharmaceutical company developing targeted therapeutics for the treatment of cancer, positively confirming the value of the company’s proprietary technology in China’s growing market even as the company handles a domestic lawsuit.

On January 18, Peregrine reported that Shanghai Medipharm Biotech (Medipharm) has launched an iodine-131 labeled Tumor Necrosis Therapy (TNT) antibody for lung cancer treatment in the People’s Republic of China. Earlier in January, Peregrine  reported that it has filed a lawsuit alleging breach of contract against its licensee Cancer Therapeutics Laboratories, Inc. (CTL), a California company that licensed certain rights to Peregrine’s TNT platform for development and commercialization in China. Peregrine also simultaneously announced that it has established a wholly foreign-owned enterprise, Peregrine Beijing Pharmaceuticals Technology Development Ltd., in Beijing.

Peregrine’s TNT anti-cancer platform consists of therapeutic radioactive isotopes attached to monoclonal antibodies that are specifically designed to bind to a type of DNA that is exposed on the dead and dying  TNT compound targets tumors and delivers its anti-cancer radioactive agent to the center of the mass, killing the tumor from the inside out and avoiding damage to the surrounding healthy tissue. The TNT platform also includes the investigational drug Cotara®, which is undergoing phase II trials for treating malignant brain tumors (glioblastoma multiforme) in the US and India.

In 2003, Medipharm reported results of a clinical study of advanced lung cancer patients in China. After treatment with the TNT agent, 4% of patients underwent complete remissions, almost 31% has partial remissions involving more than 50% tumor shrinkage, 55% experienced no change in their tumor masses, and about 10% showed progressive disease. These  encouraging results prompted a market launch of the treatment in China.

But the Chinese company is in a sublicense agreement with CTL, which had licensed certain rights to Peregrine’s TNT  technology, and is now being sued by Peregrine under various alleged breaches of contract. The lawsuit was filed in the Superior Court of the State of California for the County of Orange against CTL and cites breaches of contract that include: failing to provide sufficient clinical data to Peregrine regarding the TNT agent; failure to account for an alleged sublicense agreement with Medipharm despite repeated attempts by Peregrine to obtain evidence of such an agreement; and failure to provide any substantive accounting of revenue, equity and data obtained from the above purported sublicense agreement.

Following the CTL lawsuit, Peregrine is exploring options regarding other avenues for the technology’s commercialization in China. The company plans to pursue development and commercialization on its own through its new wholly owned subsidiary in Beijing.

Introgen Sees Advances on Two Fronts

Biopharmaceutical company Introgen Therapeutics Inc., located in Austin, TX, has reported positive news on two of its targeted molecular therapeutic products for the treatment of cancer.

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