Current Clinical Trials
LSO has completed Aptocine treatment in a Phase 3 trial in hepatocellular carcinoma and in a Phase 3 trial in colorectal cancer metastatic to the liver. LSO has also completed treatment in Phase 1 and Phase 2 clinical trials in benign prostatic hyperplasia (BPH).
Aptocine™ at work
Emitting red light at a discrete frequency and intensity and for a fixed time period, the LEDs activate Aptocine, which in turn generates reactive singlet oxygen that creates a 2-cm by 4-cm “treatment region” around the LED array. An energized Aptocine molecule results in the production of singlet oxygen, which can kill target tissues with minimal side effects through vascular closure and apoptosis, or “programmed cell death.” Illumination with low-intensity light can continuously energize each molecule of Aptocine, resulting in a continuous supply of singlet oxygen molecules.
Aptocine™ Advantages
Aptocine has the potential to become a leading treatment of solid tumors, BPH, and other conditions due to its advantages over current treatments. These advantages include the following:
- Aptocine is a targeted treatment. Activation of Aptocine occurs only where light is delivered in sufficient quantity. In addition, Aptocine has been shown in preclinical and human studies to specifically concentrate in tumors. Immune system effects on untreated tumors appear to be restricted to cells that share specific antigens expressed by treated tumor cells.
- Aptocine may access a wide range of solid tumors throughout the body. Life-threatening tumors can be treated in areas of the body where surgery is not feasible.
- Aptocine’s direct cytotoxic and vascular-closure effects are independent of tumor-specific biochemistry and therefore its efficacy may not depend on the type of solid tumor treated, the growth stage of tumor cells, or specific receptors or antigens present on the tumor.
- Aptocine treatment is repeatable. LSO’s studies indicate tumors do not develop resistance to Aptocine as has been observed with other tumor therapies. Furthermore, Aptocine treatment kills tissue via apoptosis, thereby avoiding scarring and inflammation that can prevent re-treatment.
- Aptocine may stimulate the immune system to attack untreated tumors. Human Aptocine trials produced images that show destruction of large tumors not directly treated with Aptocine. Data from published preclinical research demonstrates that Aptocine yields tumor-specific clones of CD8+ T-cells that infiltrate and destroy distant, untreated tumors (Bromley 2009).
Aptocine may additionally exhibit cancer vaccine-like effects. In preclinical studies, Aptocine-destroyed tumor tissue appears to have stimulated the immune system. This may reflect the stimulation of an immune response to the specific antigens present in the tumor. Aptocine does not appear to depend on “guessing” at a single antigen. - Aptocine advantages over existing therapies for BPH may include minimal side effects, safety, and repeatability.
- Aptocine does not require expensive equipment, unlike radiation therapy, cytotoxic chemotherapy, biological therapies, laser-based therapies and thermal tissue destruction methods—where there is no or inadequate reimbursement for the equipment and supplies used. Aptocine is a drug with the included disposable light-emitting drug activator. All components needed for activating the drug are included in the Aptocine package. Thus, Aptocine is expected to have fewer non-reimbursed costs than other forms of cancer therapy.
- Aptocine is protected by a broad portfolio of intellectual property: LSO currently has 200+ issued patents and applications on file protecting the Aptocine technology.
References
- Bromley E, Owczarczak, Keltner L, Wang S, Gollnick SO: Characterization of an anti-tumor immune response after light-activated drug therapy using talaporfin sodium in a spontaneously metastasizing mammary tumor model. 2009 ASCO Annual Meeting. J Clin Oncol. May 20 suppl: abstract 3052.