Specific Conjugate Particle (SCP) therapy is a nanotechnology where we combine two differentand independently acting moietiesinto one hybrid synergistic compound. Often one moiety is naturally occurring, and the efficacy and safety of both are proven. Key features of SCP technology are that it significantly increases the solubility of hydrophobic compounds (by an average of 10-fold), and the potency of the new composite is greater than the sum of each moiety.
We can produce SCPs in both an oral and parenteral form , and in general concerningthe oral route,SCPs are stable and do not aggregate at extremes of pH such as in the stomach. We have studied and confirmed the site of gastrointestinal uptake and subsequent tissue distribution of SCPs including larger molecules of up to 60 nm in diameter (such as SCP vaccines) through animal studies using correlative instrumental neutron activation analysis and electron microscopy. To test the robustness of the platform and the feasibility of making a broad range of SCP compounds, we have successfully produced SCP forms of 106 medicationsthat constitute a broad range of size and type of moiety.
Our initial efforts focused on developing a pipeline of oncology compounds to overcome the challenge of low solubility and the limitedcapacity of conventional chemotherapeutic agents to penetrate cancer cells especially after primary treatment modalities such as surgery, radiation, and prior chemotherapy.
To date, we have completedfourclinical trials with SCP compounds containing Doxorubicin, Paclitaxel, Cisplatin, Epothilone, and Methotrexate, where the indications were cervical cancer , soft tissue sarcoma , glioblastoma multiforme and carcinogenic pain. We enrolled 277 patients into those studies with 129 subjects receivingSCP compounds. The progression-free survival rate was 2-3 times greater, and adverse eventswere 2-3 times less frequent following therapy with SCP-drugs when compared to conventional chemotherapeutic medication.These superior results are statistically significant and may also be due to better penetration of SCPsinto cancerous tissues and through natural physiologic barriers (e.g. the Brain Blood Barrier), and an additional synergistic effect on non-chemotherapeutic inhibitors for cellular pathways that promotetumor cell resistance to conventional therapy. We have three ongoing clinical trials. Our plan is to pursue an expedited (505(b)( 2)) route to regulatory approval for these medications.
We are now increasing our pipeline of SCP medications to include indications such as reproductive care (in-vitro fertilization) and vaccines. We invite you to explore our site, where you will find additional information including summaries of our recent clinical studies.
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