The Industry Insider: March 2007

THEINDUSTRYINSIDER

FDA OKs Ikonisys’ Bladder Cancer Test

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konisys 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

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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

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iopharmaceutical 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.

First, the company was invited to present biomarker data on its ADVEXIN p53 tumor suppressor therapy, which is now undergoing phase III clinical trials for head and neck cancer treatment, at an international cell and gene therapy conference.

Introgen’s ADVEXIN therapy combines the p53 tumor suppressor gene with a nonreplicating adenoviral gene delivery system. The company has previously reported that for recurring head and neck cancers, the therapy leads to tumor responses and median survival rates comparable to those obtained with other more toxic therapies. The new expanded biomarker studies show that recurrent head and neck cancer patients with the abnormal p53 biomarker had the most survival benefits when treated with ADVEXIN and least likely to benefit from conventional therapies. Patients with tumors abnormally expressing the p53 biomarker had a median survival of11.6 months, while the other patients had a median survival of 3.5 months. Further, tumor control was seen in 75% of the patients with the abnormal biomarker; in patients without the biomarker, 18% experienced tumor control. Introgen is currently seeking to register the therapy in the US and Europe and plans to use the updated biomarker studies to help in obtaining licensure.

The other good news came for the company’s INGN 241 therapy in a preclinical study done at the MD Anderson Cancer Center, which showed INGN 241 in combination with Avastin® resulted in complete lung cancer tumor inhibition and regression.

Like the ADVEXIN therapy, INGN 241 also employs a tumor suppressor gene called the mda-7 gene, which induces cell death. The new study published in Molecular Therapy showed that the combination of INGN 241 and Avastin blocked the formation of new blood vessels in a tumor very effectively—tumors completely regressed within the first four weeks of therapy. In contrast, when the animals were treated only with Avastin, they experienced minor tumor regression and the tumors were not eradicated.

INGN 241 is currently being tested in phase III clinical trials combined with radiation therapy for the treatment of head and neck tumors.

Debiopharm Procures Cancer Therapy from Kirin Brewery

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ebiopharm will gain exclusive rights for the development and commercialization of Debio-0719, an LPA inhibitor. The drug, which was discovered by Kirin Brewery, has applications as a therapy for local and metastatic cancer. Kirin will maintain these rights in Asia, and relinquish the rest to Debiopharm.

Kirin Brewery signed a deal with Debiopharm, a biopharmaceutical development company that specializes in oncology. The deal is an exclusive research and development and commercialization agreement for Debio-0719, a local and metastatic cancer therapy. Under the terms and agreements, Debiopharm will be responsible for all aspects of the development of Debio-0719. After the development, Debiopharm maintains the rights to out-license the therapy to sales and marketing partners, excluding Asia where Kirin will keep both development and commercialization rights. Kirin will also be eligible for milestone payments, as well as royalties based on Debiopharm’s sales.

Debio-0719 is an inhibitor of Lysophosphatidic acid (LPA) signaling. LPA plays an important role in controlling tumor growth through signal transduction pathways, which makes it a significant target against cancer. Debio-0719 is currently being tested in preclinical trials against local and metastatic cancer.

Debiopharm has successfully developed and marketed two cancer therapies. Decapeptyl® is a luteinizing hormone releasing hormone agonist, which can be used to treat sex hormone-dependent diseases, including prostate cancer. The company has also developed Eloxatin®, an anticancer chemotherapeutic. The drug is a part of the platinum complex series, which targets testicular, ovarian, bladder, and lung carcinomas.