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
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.
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.