Fact Sheet
October 2010

 

This Fact Sheet provides a broader research perspective and background guiding the genesis and development of IntraTherapies Neurosystemic Medicine and Epigenetic Cancer Therapeutics initiatives.
 

IntraTherapies Institute is initiating multi-site treatment programs for its oncology platform defined as IECT-IntraTherapies Epigenetic Cancer Therapeutics. The program utilizes known FDA approved compounds redirected to clinical targets previously unaddressed or unrecognized in the domains of age-related degenerative disorders within the construct of human senescence, and late stage cancer therapeutics.
 

IntraTherapies involvement with epigenetics originated in 2001 with a platform of neurometabolic / neuroendocrine regulating compounds intended to modulate the pathophysiologies of age related degenerative disorders and also confer neuroprotective benefits over time. Epigenetics refers to the reversible, heritable changes in gene regulation that occur without a change in DNA sequence. These changes, known as gene expression, can be addressed and regulated by pharmacologic processes. IECT developer Nathan Sassover identifies this as DNA-PGP: DNA Programmable Genetic Pharmacology. He has further unified IntraTherapies integrative approach within a personalized medicine framework he defines as Epigenetic Neurobiology.

The clinical pathways focusing on neurosystemic therapeutic and preventive protocols has evolved under the guidance of inventor and IECT developer Nathan Sassover and protocol designer, IntraTherapies Medical Advisor, Dr. Brent Treiger, MD, a research oncologist with a diverse fifteen year drug development background. Dr. Treiger is the developer of the ovarian cancer drug, Doxal. The impetus for launching the IECT cancer treatment program follows initial highly encouraging outcome in a clinical study of one Advanced Breast Cancer patient. Following eight weeks of outpatient treatment, PET /CT scan radiology reports confirmed significant tumor reduction, further corroborated by radiology oncologists clinical reports, as well as hematology analysis confirming improved cancer blood titers.

In the same time period, October 2008 - January 2009, parallel initial studies in a male patient with advanced Metastatic adenocarcinoma of the colon, also yielded encouraging meaningful reduction in key cancer titer blood levels as evidenced by hematology lab data confirmed by the attending physician administering the protocol during the eight week period.

Following these indicative outcomes, IntraTherapies has focused on deeper clinical inquiry related to possible relevance of IECT as a pathway-specific protocol for other solid tumor and hematologic cancers.
 



The IntraTherapies oncology platform is defined as :

IECT-IntraTherapies Epigenetic Cancer Therapeutics:
Clinical Protocols based on Molecular Cancer Genetics and DNA Programmable
Genetic Pharmacology to Inhibit the Growth, Replication and Proliferation of Human
Cancer Cells.

An eight month research initiative was focused on developing a basis for intervention in a total of six (6) solid tumor categories which serve as the basis for a broader Cancer Epigenetics Program with the objective of validating evidence-based safety / efficacy across the accepted ASCO (American Society of Clinical Oncologists) standards of PFS - Progression Free Survival / OS-Overall Survival, and QOL-Quality of Life measurable criteria.
 

The company has also established its IECT clinical management team which brings the requisite hematology / oncology experience to the task of initiating and administering this epigenetic treatment platform which utilizes known FDA approved compounds.

IECT- IntraTherapies Epigenetic Cancer Therapeutics Protocols target six solid tumor cancer lines and two hematological malignancies.

Advanced Stage III and IV Breast Cancer
Metastatic (Stage IV) Colon Cancer
Metastatic (Stage IV) Castration-Resistant Prostate Cancer (CRPC)
Advanced (Stage III and IV) Non Small Cell Lung Cancer (NSCLC)
Advanced (Stage III and IV) Ovarian Cancer
Metastatic (Stage IV) Renal Cell Carcinoma (Kidney Cancer

Hematologic Malignancies:
MDS - Myelodysplastic Syndrome - CML AML Leukemia

The multi-city cancer epigenetics program was initiated with World Cancer Institute, intended as a public forum and informational resource focusing on preventive and integrative cancer therapeutics, based on scientifically validated research within known medical research centers and corresponding publication of scientific studies in globally recognized peer-reviewed medical journals and professional medical associations and clinical presentations.
 

IntraTherapies primary objectives with the IECT programs presented here are to advance the clinical potential of DNA Demethylation and other Epigenetic cancer interventional and preventive modalities and techniques utilized singly or in conjunction with metronomic very low dose chemotherapy, further optimized by drug delivery methods which are easier to accommodate for patients with late stage cancers, where treatment outcomes are of diminishing effect in second, third and fourth line administration of conventional chemotherapy.

Provide a daily treatment regimen with functional transparency, clinically verified efficacy with evidence-based reduction in patient toxicity levels. In parallel, utilize clinically validated QOL instruments to assess long term quality of life factors attending extended treatment of late stage cancer patients without compromise of safety.

Within a majority of healthcare settings, it is an established statistically recognized fact that 80% of chemotherapeutic pharmaceutical and biopharmaceutical interventional treatments are not effective. In conjunction with World Cancer Institute, the broader objective is bringing a clinical focus and new pathways of currently accessible treatment to the most medically challenging condition known to mankind… human cancer.

Often times a clinical initiative can find itself well timed - in tune with an emerging consensus, a turning point which can have the unintended ‘side effect’ and benefit of serendipity. Such is the case with the Obama administration’s view of the importance of advancing the creation of research programs to treat and hopefully cure cancer, while, in the President's words, "…bypassing the ‘choke point’ of clinical trials to bring important medical discoveries forward."

In summary, the enlarging healthcare crisis in the US and increased focus redefining the 'War on Cancer' after marginal outcome over the past thirty years, warrants greatly accelerated attention in addressing the global progression of all forms of cancer and the life science developments which are seeking avenues of medically validated prevention and intervention.