Novel Cancer Therapeutics--Overcoming Antigen Silencing

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Combining Immunotherapy and Tumor-Antigen Induction in Human Melanoma

To fast track CytoCure’s first therapeutic product the company has formed strategic alliances to implement a combination immunotherapy clinical trial that will use Interferon-beta to enhance expression of the tumor antigens on the malignant melanoma cells in vivo.  A consortium of  major academic medical centers in Australia has agreed to provide patients and laboratory assessment facilitites for this combination immunotherapy / interferon-beta trial in melanoma. This clinical trial will qualify for approval by the United States Food and Drug Administration (US-FDA).

The Malignant Melanoma Market Place

Because of its resistance to conventional therapy, novel therapeutics represent the best hope for patients with advanced disease. During the 20th century, the incidence of melanoma rose at an alarming rate. In 2000, approximately 80,000 people were diagnosed in the seven major pharmaceutical markets. Australia and New Zealand have by far the world’s highest incidence of malignant melanoma. Factors influencing pharmaceutical sales will include the increase in malignant melanoma incidence, a trend toward more aggressive treatment of the disease, and combined drug and immunotherapy products such as those being developed by CytoCure. Health expenditures on melanoma in the United States alone  are soon expected to exceed 5 billion US$, with major expenditures on patients whose disease cannot be controlled by currently available therapies. Although initial implementation of therapies will likely focus on patients with demonstrated metastatic disease, the prospective treatment of patients with no demonstrable disease as prophylaxis against recurrence could expand the targeted population exponentially. If approved for the treatment of melanoma, this combination therapy could qualify for “orphan” drug status for treatment of diseases with less than 200,000 cases per year, providing an exclusive market for 7 years in the United States. The European Union has also developed an orphan drug program for treatment of diseases that affect less than 5 in 10,000 population.

Beyond Melanoma

Therapies of Additional Tumors: While the initial studies by CytoCure scientists have focused primarily on malignant melanoma, CytoCure has evidence that other tumor types will similarly turn off the expression of their antigens. Cancers such as renal cell carcinomas have also proved amenable to active immunotherapeutic intervention. Furthermore, a wide variety of tumor antigens expressed in cancers of the breast, colon, prostate, ovary, uterus, stomach, pancreas, lung, brain as well as lymphomas and leukemias, have been described which can be used as targets of active immunotherapy if the expression of these antigens can be assured and enhanced. Some of the same antigens that are targeted in melanoma are also expressed on brain tumors, and CytoCure's studies indicate that brain tumor cells are likewise able to enhance antigen expression in response to  many of the same agents that CytoCure has shown are active in malignant melanoma.