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Three Valuable Patents, Potential FDA Filing (OTC:PWRM)


Power3 Medical Products, Inc.

(Public, OTC:PWRM)

The following company analysis has been contributed by a StocksHaven Investments affiliate and member, Michael Sklar. He has been studying the markets for several years now with a focus in undiscovered Bio-Pharm companies.

About

Power3 Medical Products, Inc. (Power3) is primarily engaged in commercializing its intellectual properties in the area of diagnosis and treatment of breast cancer, Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease. In the area of neurodegenerative diseases and breast cancer, Power3 has completed research and clinical validation studies involving over 1,500 patient samples. Power3 uses biostatistical analysis to monitor appropriate panels of biomarkers for diagnostic sensitivity and specificity for disease, normal and disease controls. By testing patient body fluids and tissues, including blood serum (for breast cancer and neurodegenerative diseases), and bone marrow aspirates (for leukemia patients), the Company has discovered protein biomarker patterns in over 1,500 patient samples that cover a range of diseases.


Three Valuable Patents, Potential FDA Filing

Power3 Medical is a breakthrough proteomics company specializing in the identification of disease footprints in the areas of chemotherapeutic drug resistance and the early detection of breast cancer and neurological diseases opposed to late stage detection.

They have recently filed for 3 utility patents due to their advances in early stage breast cancer research and are expecting to complete phase II clinical validation trials of their blood serum diagnostics for Alzheimer’s and Parkinson’s disease (NuroPro AD and PD), in the fourth quarter of 2009, followed by completion of filing with the FDA. The medical testing industry is huge and extremely profitable.

Proteomics is the study and analysis of proteins, the fundamental building blocks of the human body. By studying proteins, scientists can understand more fully the functioning of a healthy body and identify the proteins associated with specific diseases. Proteins are not only the building blocks for life; in them, evidence can be found for serious diseases such as cancer, neurodegenerative diseases and other life threatening diseases. The research platform is centered on the study of proteomics, the science of protein interactions within living cells. With a combined 50+ years of proteomic experience, the Company has identified 334 protein biomarkers with the following potential medical applications:

  • Breast Cancer
  • Alzheimer’s Disease
  • ALS (Lou Gehrig’s Disease)
  • Parkinson’s Disease
  • Leukemia
  • Gastrointestinal Disease
  • Metabolic Syndrome
  • Chemotherapeutic Drug Resistance

These discovered and patent-pending biomarkers solve critical challenges facing pharmaceutical and diagnostic companies and are currently being used to design tests to diagnose diseases and discover targets for new drugs to treat the diseases.

Each validated biomarker, pattern, new diagnostic test, or drug target, may have a potential market value from $10 – $100 million plus.

Filing for 3 Utility Patents
On August 20th 2009 Power3 Medical announced that they filed for 3 utility patents due to their significant advances in the technology for their BC-SeraPro serum protein based blood test for diagnosis of EARLY STAGE breast cancer. The significance of these testing methods opposed to mammogram an biopsies is that they are NON-INVASIVE and EARLY DETECTION is through quick blood work rather than detecting tumors that can take many years to form. Currently the standard test for breast cancer is having a mammogram done, however, mammograms usually only pick up tumors that have been growing for 3+ years. BC-SeraPro serum protein based blood test immediately tests for a protein that only cancerous cells release. The FDA has determined that clearance or approval is not necessary for this test by the U.S. Food and Drug Administration because it is used for clinical purposes.The CLIA certification that they have is sufficient for this test to be legally marketed and performed.

In the United States, there were 216,000 cases of invasive breast cancer and 40,000 deaths in 2004. Worldwide, breast cancer is the second most common type of cancer after lung cancer(10.4% of all cancer incidence, both sexes counted) and the fifth most common cause of cancer death. In 2004, breast cancer caused 519,000 deaths worldwide (7% of cancer deaths; almost 1% of all deaths)

Taken from the recent press release:

“In the US, roughly 40,000 women die of the disease because the cancer is caught too late. In fact, nearly 1/2 of all cancers are missed as false negatives, and 75% of the biopsies of suspected breast cancer performed are false positive and therefore could have been avoided if there was a more accurate test that could be made readily available,” said Ira L. Goldknopf, Ph.D., president and chief scientific officer of Power3. “We now have made strides towards this goal through refinements in our blood test for early stage detection of breast cancer.”

As disclosed in the patent applications, Power3 has identified a group of 22 blood serum proteins with abnormal concentrations in women with breast cancer. Using the company’s BC-SeraPro platform, Power3 used these protein biomarkers to distinguish women with breast cancer from those with benign abnormal breast conditions and with normal breasts with sensitivities and specificities in the 80-90% range, in retrospective banked and prospective newly drawn samples from patients and controls. The biomarkers also distinguish between women with purely invasive primary breast cancer and women who also have ductal carcinoma in situ, which is often missed in mammograms. In addition, following the “Principals of Omic Medicine” that Dr. Goldknopf is promoting at international scientific meetings in the US and China, the company has disclosed methods for making biomarker specific antibodies for development of a user friendly commercial test for breast cancer.

“We are enthusiastic about the increased value of BC-SeraPro with these 3 exemplary patent filings. Although we are striving to commercialize with our tests, we also recognize that this work has potential to alleviate much suffering,” commented Ms. Helen R. Park, CEO of Power3. “Thus we will be publishing our results in the near term.”

A recent independent article was published entitled  “The Rationale for a Blood Test to Detect Early Breast Cancer” By Alan B. Hollingsworth, MD. He is the Medical Director of Breast MRI of Oklahoma, LLC, Medical Director of Mercy Women’s Center and Mercy Cancer Resource Center. It can be found here [ source ]

Potential FDA Filing 4thQ 2009

Taken from their press release concerning  the Positive phase I results and the  completion of  phase II clinical validation trials of its blood serum diagnostics for Alzheimer’s and Parkinson’s disease (NuroPro AD and PD), in the fourth quarter of 2009, followed by completion of filing with the FDA :

A breakthrough, which involved the successful diagnoses of different forms of Alzheimer’s, including high-risk patients, was achieved during the initial phase of clinical validation trials of the Company’s NuroPro® AD blood test. Prospective clinical validation trials of the NuroPro® AD for newly drawn samples, phase one for which is now complete, confirmed previous results recorded by Power3. The NuroPro AD test was developed to help clinicians diagnose patients with Alzheimer’s, as well as to distinguish those with Alzheimer’s from normal individuals and patients with other neurological disorders. The NuroPro test, developed by Power3, utilizes a panel of blood serum protein biomarkers to determine the probability that a patient has Alzheimer’s. The tests are intended to solve a critical challenge facing physicians, clinicians, and patients toward an objective, early stage and accurate diagnosis of actual disease. “In the US, there are an estimated 5.1 million individuals with Alzheimer’s disease,” said Power3’s President and Chief Scientific Officer, Dr. Ira L. Goldknopf. “The annual treatment per patient is currently in excess of $30 thousand for Alzheimer’s.” “Roughly half of the Alzheimer’s disease patients possess a gene variant that indicates a higher risk of developing Alzheimer’s disease than the general population. However, roughly 15% of normal individuals also possess this gene variant. There are also other genetic risk factors for Alzheimer’s disease,” continued Dr. Goldknopf. “Therefore, unfortunately, positive genetic tests do not inform the patient that they have the disease. They merely let them know they have a higher risk for developing it.” These latest results are from the completion of the initial phase of clinical validation trials of Power3’s NuroPro® AD tests. These tests are being conducted with newly drawn blood serum samples from 50 Alzheimer’s disease patients, together with 50 age matched normal controls, as provided by Dr. Marwan Sabbagh, Medical Director of the Banner Sun Health Research Institute, Sun City, Arizona. These initial results also confirm that the test distinguishes patients with different forms of Alzheimer’s disease, including high-risk patients, from normal individuals, including high risk individuals without disease. “This feature of the NuroPro AD test also increased the sensitivity for detection of Alzheimer’s, without genetic testing. The fact that these results were obtained using fresh blood serum from patients, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for the clinical usefulness of these findings,” added Dr. Goldknopf. Power3 is conducting the independent validation of both their Alzheimer’s (NuroPro AD) and Parkinson’s (NuroPro PD) tests with key clinical centers. The second phase of these prospective trials, as well as the launch of the CLIA-certified testing services, are both slated to commence sometime in late 2009. According to Helen R. Park, CEO of Power3, “Progress thus far of the Company’s clinical validation trials confirms our belief that Power3’s NuroPro AD will significantly help physicians make diagnoses and recommend appropriate follow-up and treatment options for their patients, based on the presence of disease. This is a huge advance over only being capable of informing a patient that his or her risk is high……..

Power3 expects to complete phase II clinical validation trials of its blood serum diagnostics for Alzheimer’s and Parkinson’s disease (NuroPro AD and PD), in the fourth quarter of 2009, followed by completion of filing with the FDA.

Business Overview

Power3 Medical’s business focus is the development of commercial applications for their proprietary technologies. The scientific team is on the leading edge of the proteomics industry through their discovery of protein footprints, pathways, and mechanisms of disease. These discoveries are being used to develop screening and diagnostic tests for the early detection and treatment of disease. The protein biomarkers, drug targets, and diagnostic tests are targeted toward markets with critical unmet needs in areas such as breast cancer, neurodegenerative disease and drug resistance in cancer. The Company is in a strong competitive position with over 190 identified biomarkers and a state-of-the-art proteomics laboratory.

The Company’s current IP portfolio offers potential revenue sources in the following areas:

  • IP licensing to diagnostic companies engaged in the development of early detection/screening tests
  • IP licensing to pharmaceutical companies engaged in drug targeting
  • Biomarker Sales
  • Exclusive Laboratory Analysis Agreements

All of these business operations have the potential to generate significant and stable revenues in the form of royalties, licensing fees, milestone payments and marketing agreements.

Power3 quickly and accurately identifies patterns of proteins associated with disease and applies them to screening, diagnostics and drug targets. Once validated through clinical trials, the Company benefits financially from investing partnerships or licensing arrangements for these protein biomarkers and their applications, including upfront payments, licensing fees, milestone payments and royalties. Each validated biomarker, pattern, new diagnostic test, or drug target, may have a potential market value from $10 – $100 million plus.

Author Bio

Michael Sklar is 27 and has been studying the markets for several years now with a focus in undiscovered Bio-Pharm companies. He is a Graduate Gemologist and in the Diamond and Colored stone trade. He has been a collector of timepieces for several years, and is active in the international watch enthusiast community. When not researching companies he enjoys spending time with family and friends.

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Disclosure: M. Sklar has a position in PWRM

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