The Problem: Best in class S-Phase cytotoxics (e.g. gemcitabine, irinotecan) can kill 100% of cells that are in the S-Phase of the cell cycle. However, less than a third of cancer cells are in the S-Phase during chemotherapy.

The Opportunity: Boosting the number of cancer cells in the S-Phase from less than a third to an eventual goal of 100% would provide a market transforming technology and a major advance in the treatment of cancer. FDA approved drugs to do this already exist for many cancers, with some drugs being repurposed from other areas of medicine.

The Product: TS - CCSC protocols modulate tumor specific mutations and characteristics to achieve tumor specific S-Phase enrichment and synchronization relative to successive administrations of S-phase cytotoxic chemotherapeutics, while simultaneously inhibiting tumor regrowth between administrations of S-Phase cytotoxic. The TS-CCSC Protocol approach is a 3 step process that is repeated in cycles:

Example: A Cornell Medical School study found that around half of prostate cancers are driven by an estrogen activated cell surface receptor (fusion mutation). Under a TS-CCSC protocol, after an initial administration of an S-Phase cytotoxic to depopulate the tumor, 1) a GnRH antagonist and aromatase inhibitor would be used to zero out indigenous estrogen levels for 4 weeks to aggregate the cancer cells in the G1 Phase, 2) exogenous estrogen would then be administered to flush the cancer cells into the S-Phase and 3) an S-Phase cytotoxic would be administered daily to kill the cancer cells. The approach effectively makes the tumor specific to a non tumor specific S-Phase cytotoxic.

Overcoming Prior Art Failures: The enormous therapeutic potential of CCSC is commonly acknowledged, however prior art attempts at CCSC failed because of inadequate aggregation periods and lack of targeted aggregation. Our patents overcome these reasons for failure.

Cancers Targeted / Primary Markets: The 3 issued US patents cover TS - CCSC for endocrine dependent (ED) cancers, cancers driven by HER2 overexpression, and cancers driven by HER1 (aka EGFR) overexpression. Estimates of the prevalence of these mutations vary widely and do not typically specify the exact nature of the mutation (e.g. overexpression or inappropriate expression), making accurate projections difficult, however using prevalence alone indicates ~ 900,000 new prospective US patients annually. Conservatively assuming only 25% of the prospective patients are subsequently characterized as ideal responders would translate into 225,000 US patients annually.

Value Proposition: The value proposition for the 225,000 ideal responders would be Best Standard of Care at a fraction of the cost of expensive proprietary drug regimens.

Market Potential: A $ 50,000 annual regimen price for ideal responders translates into $ 11 Bil. in revenue.

The Proposed Business Model: The proposed “TS-CCSC Chemotherapy Centers” service model would allow participating oncologists to make more money, reduce overall cancer treatment costs, and provide funding for ongoing TS-CCSC development into new cancers. The business model effectively usurps money from expensive proprietary big pharma drug regimens and as such the cancers initially targeted would be those where TS-CCSC can displace expensive proprietary drug regimens. Publication and promotion of TS-CCSC clinical results, as well as patient recruitment, will be handled by TS-CCSC Chemotherapy Centers, with participating oncologist services built into the regimen price

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DISCLAIMER AND IMPORTANT NOTICE: The Compositions and Methods presented on this website are all in preclinical stages. They are based only on our understanding of the proposed underlying mechanisms of action and on any available coincidental corroborative empirical evidence, any of which may in fact turn out not to be correct, or may be prevented from functioning as envisioned because of other factors or mechanisms of action not contemplated or considered, or may even cause harm because of factors or mechanisms of action not anticipated. The process of obtaining FDA approvals has not been started in any of the areas disclosed on this website. The disclosures here are purely for scientific information exchange purposes, representing one scientific point of view, and are not intended to suggest, or be used for, any proposed medical treatments.

© 2010 Mark Zamoyski & NexGen Biomedical, Inc.