Overview / Objective: The industry focus on best in class S-Phase cytotoxics has resulted in drugs capable of killing 100% of cells that are in the S-Phase of the cell division cycle. However, less than a third of cancer cells are typically in the S-Phase. We believe the next generation of advances in best of class cancer treatments will come from selectively boosting the S-Phase fraction in tumors from the current one third or less to an eventual ceiling of 100%. This is the objective of our best in class protocols.

Background: All proliferating cells progress through 4 distinct phases of the cell division cycle, termed G1, S, G2, and M. S-Phase cytotoxics kill cells that are in the S-Phase of the cell cycle. Legacy protocols for S-Phase cytotoxics were developed a half century ago and were designed to allow for recovery from systemic toxicity between administrations of chemotherapy. They were not designed to be curative.

The Problem: Best in class S-Phase cytotoxics, such as Pfizer’s Camptosar® or Eli Lilly’s Gemzar®, are capable of killing virtually all cells that are in the S-Phase, however, less than one third of cancer cells are in the S-Phase during chemotherapy when using legacy protocols. In addition to this low tumor kill rate, legacy protocols do nothing to prevent tumor regrowth between administrations of S-Phase cytotoxics and do nothing to insure synchronicity of successive administrations of S-Phase cytotoxic drugs relative to the progression of the cancer cells through the S-Phase of the cell cycle. Accordingly, only modest increases in median survival are obtained using a typical asynchronous legacy regimen.

Our Solution: Our protocols are designed to provide a way of indefinitely surviving cancer. We boost the percentage of cancer cells that are in the S-Phase (termed S-Phase enrichment) during the administration of the S-Phase cytotoxic (termed S-Phase synchronization) and we inhibit cancers cells from progressing through the S-Phase prior to the next administration of S-Phase cytotoxic. We use tumor specific mutations and characteristics to aggregate cancer cells in the G1-Phase (the phase just before the S-Phase) and then release the aggregated cells into the S-Phase prior to the administration of the S-Phase cytotoxic drug.

Cancer Markets Targeted: Because our protocols use tumor specific mutations and characteristics to achieve S-Phase enrichment and S-Phase synchronization relative to successive administrations of S-Phase cytotoxics, the cancers targeted by our protocols are defined by mutation profile rather than by the legacy categorization of cancers by the cell type from which the cancer arose. The following mutations / characteristics we have defined protocols for, and have either received patents for or have patent applications pending are:

• Endocrine Dependent Cancers - Patent Issued
Cancers: ~ 50% breast, prostate, uterine

• HER2+ Cancers - Patent Issued
Cancers: ~20% breast, 30% NSCLC (lung), ovarian

• HER1+ Cancers - Patent allowed and pending issuance
Cancers: ~ 55% NSCLC, ~ 50% glioblastomas (brain), ~50% pancreatic, ~ 15% breast, colon

• Cancers That Have Metastasized to Bone - Patent Pending
Metastatic Cancers: 67% prostate, 62% breast, 56% lung, 48% melanoma, 27% colorectal, 25% bladder, 21% cervix, 12% ovary, 10% kidney

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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.

© 2008 Mark Zamoyski & NexGen Biomedical, Inc.