Company USA
Unmet Needs
Cancer is the leading cause of death in the U.S. for men and women, combined, under age 65. Lung, breast (women), prostate (men), and colorectal cancer diagnoses account for ~55% of new cancer cases and are the leading causes of cancer-related deaths. In addition, brain and oral cancer, while having relatively low incidence rates, lack effective treatment protocols and have generally poor outcomes. Resistance to current chemotherapeutic drugs remains one of the primary causes of suboptimal outcomes in cancer therapy.
The company's Solutions
The company has developed seven prototype products to (a) treat persons diagnosed with oral cancer (squamous cell carcinoma), metastatic breast cancer, and adult acute myelogenous leukemia; (b) diagnose cancer; and (c) enhance the efficacy of radiation therapy. As a whole, these prototype products are expected to enter human clinical studies over the next 12-24 months.
The Market
The worldwide market for novel anti-cancer agents introduced since 1990 was in excess of $10 billion in 2002; sales of the off-patent drugs for which the company is developing new proprietary formulations were approximately $1 billion in 2002.
Cancer Product
The compound in the company's lead product is a proven anti-leukemic agent for the treatment of acute leukemias. Leukemia is a cancer of the bone marrow and blood characterized by the uncontrolled accumulation of immature blood cells. It is primarily a disease of the elderly, with a median age at diagnosis of 68 years. Acute leukemia progresses rapidly resulting in accumulation of immature, functionless cells in the marrow and blood; that is, the marrow often can no longer produce enough normal platelets, red blood cells and white blood cells.
The company is developing its lead product for use in remission induction therapy in adult acute myelogenous leukemia (AML) in relapsed, MDR1+, elderly AML patients. Elderly AML patients are biologically and therapeutically distinct from AML in younger adults, and they are intrinsically resistant to chemotherapy and have inferior outcomes. Many elderly AML patients are not offered and/or refuse standard induction and post-remission therapy. Thus, an efficacious, relatively non-toxic approach would be welcomed by patients and leukemia specialists.
Therapeutic Vaccine
Unmet Need
Approximately 40 million people worldwide are infected with HIV. Globally, there were nearly 5 million new HIV infections in 2003 and nearly 3 million deaths. To date, no prophylactic or therapeutic vaccine has demonstrated effectiveness. Current antiretroviral therapies used to treat HIV work to prevent the virus from multiplying. While antiretroviral drugs have been shown to slow the progression HIV in infected individuals, they are expensive, require complex daily dosing regimens, and are prone to resistance.
Product
The company has utilized its Engineering technology to develop a dendritic cell-targeted HIV-1 therapeutic vaccine containing the conserved proteins Tat (1-72) and Gag p24. This novel therapeutic vaccine has demonstrated effective in-vivo immune responses in mice. Specifically, neutralizing antibodies to key epitopes on the Tat protein were generated. These neutralizing antibodies have been shown to inhibit Tat-induced long terminal repeat (LTR)-transactivation which is critical for HIV replication. Previous literature reports have shown that long-term non-progressors (LTNP) (e.g., HIV-infected individuals that do not progress to AIDS) have cellular immune responses and neutralizing antibodies to key Tat epitopes.
Thus, the company's data is highly encouraging and suggest that therapeutic immunization of HIV-infected patients with a highly conserved Tat protein may significantly delay or perhaps avoid the progression to AIDS. Moreover, this product would avoid the longer development path of a conventional prophylactic vaccine while affording significant advantages over existing antiretroviral drugs used in the current standard treatment protocol -- “highly active antiretroviral therapy”
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