The American Cancer Society estimates that over 1.6 million new cases of cancer will be diagnosed in the United States in 2012 [REF 7]. The lifetime chance of developing cancer is 1:2 for men and 1:3 for women. Cancer strikes all ages, races and segments of our society. Despite significant advances in recent years, cancer is the second leading cause of death in the United States, responsible for almost 600,000 deaths annually. Additionally, traditional therapies for cancer do not specifically target the cancer cells and therefore cause significant debilitating side effects. In an effort to specifically target the cancer cells, biologists and drug developers have long sought to harness the patient's own immune system for the treatment of cancer. In recent years, progress has been made on this goal with the successful development and approval of Yervoy (ipilimumab) for advanced-stage melanoma and Provenge (sipuleucel-T) for the treatment of advanced-stage prostate cancer. These therapies work by stimulating or assisting the body's active immune response to fight the tumor. Active immune therapies cause the patient's immune system to adapt to the ever-present changes in the tumor. In contrast, passive monoclonal antibody therapies do not stimulate the patient's own immune defenses to combat the cancer and therefore mutating cancer cells can often evade these therapies. Immunotherapy approaches hold particular promise to treat the cancer while sparing normal tissues.
The Role of Galectin-3 in the Body's Immune Response to Cancer
A number of studies have suggested that galectin-3 impairs the active immune system's attack on cancer [REF 8, 9]. Specifically, these publications have shown that cancer cells secrete high levels of galectin-3, which serves to deactivate the body's immune response to the cancer cell.
GCS-100 for Cancer
By antagonizing galectin-3, GCS-100 disrupts this mechanism of immune evasion and has the potential to activate the patient's immune system to fight cancer. Preclinical studies of GCS-100 have shown that GCS-100 can reactivate killer T-cells directed at the cancer that have been silenced by galectin-3 [REF 9]. Because GCS-100's mechanism of immune activation is complementary to those of approved cancer immunotherapies Yervoy and Provenge, there is the potential that GCS-100 will work in synergy with them and similar agents. GCS-100 has been studied in over 100 cancer patient and has demonstrated activity in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and renal cell cancer (RCC). We believe that the safety profile of GCS-100 to date has been excellent, with mild-to-moderate, self-limiting rash as the principal side effect.
We plan on evaluating GCS-100 in combination with Yervoy in preclinical models. This work builds on previous studies in which GCS-100 was shown to be additive or synergistic with several chemotherapeutic and targeted anti-cancer agents. Following successful completion of this study, we plan on initiating a clinical trial in melanoma.
We are dedicated to developing safe and effective therapies for significant life-threatening diseases including organ failure and cancer. We are attacking these fatal disorders by targeting galectin-3, a member of the galectin family of proteins that is implicated in their pathology. Our lead product candidate against galectin-3, GCS-100, has been tested in more than 100 patients and is generally well tolerated. We have an experienced management team dedicated to accomplishing our corporate milestones, as well as sufficient cash to execute on these near-term activities. Please visit us at http://www.ljpc.com.
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