Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA
This is a Phase I Safety Study which investigates the role of PolyMVA as a supplement in
grade IV astrocytoma patients. The primary endpoint of this study is safety/tolerability.
This supplement, PolyMVA, is a uniquely formulated combination of minerals, vitamins, and
amino acids. The principle ingredient is the Palladium Lipoic Acid Complex (PdLA). There
is no free alpha-lipoic acid or free palladium in Poly MVA; they are bound together (Garnett
1995, Krishnan and Garnett 2005). PolyMVA is both water and lipid soluble. It is uniquely
arranged in a liquid crystal polymer structure, allowing it to store a great deal of energy,
and thus serve as a semi-conductor. The overall function of this polymer is that it
provides a unified redox reaction (accepts and donates charge), and acts as a highly
effective energy-transferring molecule. It is able to rapidly and efficiently transfer
electron charge to DNA, protecting non-cancerous cells from the oxidative damage of
radiation and chemotherapy.
Over the past years neuroscientists from our institution have used tissue culture techniques
to study the effects of PolyMVA (PdLA) on the apoptotic cell death cascade in cancer cells.
The work was predicated on the Nobel Prize winning discovery by Dr. Otto Warburg that
cancerous tumors are oxygen deficient and rely upon anaerobic metabolism for energy
production. Malignant cells have thus adapted to function in a hypoxic environment;
however, since anaerobic metabolism produces less energy per unit of fuel, tumor cells are
less efficient at energy production than normal healthy cells. PolyMVA (PdLA) takes
advantage of this metabolic situation. PolyMVA (PdLA), by transferring excess electrons to
malignant cells (which are functioning in a limited oxygen environment), is responsible for
the selective generation of free radicals within the mitochondrial membrane of malignant
cells. Free radical generation in this region facilitates cytochrome c release, activation
of the apoptotic cascade, and, ultimately, cancer cell death.
Furthermore, electrochemistry data and ischemia data from our institution both have
elucidated that shuttled electrons do not go directly to DNA, but pass via the mitochondria.
(This route was determined by competitively blocking the efficiency of PolyMVA (PdLA) with
free alpha lipoic acid, which works at complex I of the mitochondria.) Therefore,
electrons, en route to DNA, are shunted down the electron transport chain. The result:
enhanced cellular energy in a non-malignant cell. (Clinically, this is a process which
would not only benefit cancer patients who, as a result of toxic therapeutic regimens and
cancerous invasion, are energy-depleted; but this would also benefit normal healthy subjects
who experience fatigue, or, who are simply looking for an energy boost.)
Poly MVA not only functions as an energy-transferring molecule, but also as a free radical
scavenger (it is able to quench radical species). It is the combination of these
activities, which may benefit cells exposed to ischemic conditions. During an ischemic
insult, Poly MVA has the ability to shuttle electrons from the plasma cell membrane to the
mitochondria, and thus stabilize the vulnerable electron transfer chain. Additionally, its
liquid crystal polymer activity has the ability to quench any radicals generated upon
reperfusion. This non-toxic novel supplement may therefore serve as a potent anti-ischemia
Eight teaspoon daily dosage of PolyMVA in grade IV astrocytoma patients is safe and
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Number and Severity of Adverse events as a Measure of Safety and Tolerability
Adverse Events will be recorded throughout the course of the study and scaled for severity according to CTCAE v. 4.02. AE's will also be scaled for relatedness to the study compound and will be adjudicated by a DSMB. MRIs will be obtained at baseline, 26 weeks ans 34 weeks. We will look for disease progression according to MacDonald criteria. Blood work and urinalysis will also be obtained at every visit. Tolerability will be based upon subject questioning.
Candice Perkins, MD
Stony Brook University Medical Center
United States: Food and Drug Administration
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