CURAXIS Pharmaceuticals - (CURX)
About Us
Curaxis Pharmaceutical Corporation is a specialty pharmaceutical company dedicated to finding cures for major age-related diseases. Our initial focus is Alzheimer’s Disease (or AD).
Our lead product is a patented treatment that has shown the potential for treating and halting the progression of this devastating disease. Today, over 5,300,000 Americans suffer with Alzheimer’s Disease.
It is estimated that more than $100 billion is spent annually in the United States to treat and care for those with this ailment. Sadly, these numbers are growing every day as the situation for many patients and their families grows desperate, despite the millions of dollars spent annually to find the answer to effectively treating this disease.
Curaxis Pharmaceutical is moving to guide our patented treatment through the necessary clinical trials in order to make it available for patients as quickly as possible. Management believes this product represents a major new development in the battle against Alzheimer’s Disease. Currently, no medications or treatments halt or materially slows the progression of this disease. Our research results provide a very strong scientific explanation for the age-related onset of the disease, as well as its progressive nature.
Curaxis’ strategy is to initiate enrollment and dose the first patient in a Phase II clinical trial in women with mild to moderate Alzheimer’s disease in 2010. This major step for our Company will signify the next stage in the development of Curaxis Pharmaceutical and a major milestone towards commercialization of our premier product to treat Alzheimer’s Disease.
CURX On Alheimers Disease
The 2011 Curaxis Pharmaceuticals Corp Annual Meeting of shareholders will be held on November 8th 2011. Please click here to download the proxy materials and to vote.
https://www.iproxydirect.com/index.php/CURX
Curaxis Pharmaceutical Corporation is a specialty pharmaceutical company dedicated to finding cures for major age-related diseases. Curaxis' initial focu s is Alzheimer's Disease (or AD). The lead product is a patented treatment, Memryte, that has shown the potential for treating and halting the progression of this devastating disease.
The Problem
Washington DC, May 19, 2010, A new report from the Alzheimer’s Association, “Changing the Trajectory of Alzheimer’s Disease: A National Imperative” shows that in the absence of disease-modifying treatments, the cumulative cost of care for people with Alzheimer’s from 2010 to 2050 will exceed $20 trillion in today’s dollars.
The new report is not all bad news, however, as it shows that Medicare and Medicaid can achieve dramatic savings - and lives could be significantly improved - with even incremental treatment improvements.
Harry John’s, President & CEO of the Alzheimer’s Association said, “ Today, there are NO treatments that can prevent, delay, slow or stop the progression of Alzheimer’s disease. While the ultimate goal is a treatment that can completely prevent or cure Alzheimer’s, we can see that even modest improvements can have a huge impact.”
Market Need - Curaxis Solution
Currently marketed Alzheimer's drugs target the symptoms of Alzheimer’s disease by enhancing some patients’ cognitive function and general behavior, but generally are not thought to slow progression of the disease.
Only about 50% of patients taking AChEIs (acetylcholinesterase inhibitors - current theory) experience a modest improvement in cognitive function. According to the Alzheimer’s Association, for those patients who show improvement, the benefit typically lasts for only six months to one year.
Based on preclinical and clinical results achieved to date, Curaxis believes that Memryte may substantially slow the progression of Alzheimer's disease and represent a significant clinical improvement over current drugs.
Corporate Office
Curaxis Pharmaceutical Corp.
1004 Chagford Way
Raleigh NC 27614
United States
Curaxis’ Theory
Curaxis’ scientific theory is novel yet consistent with current theories of Alzheimer's Disease (AD) and the major hypotheses regarding the cause(s) of Alzheimer’s disease.
Alzheimer's disease (AD) is a neurodegenerative disease that ultimately leads to death in afflicted individuals. Previous estimates suggest that there are 4.5 million people with AD in the U.S. alone, many of whom remain undiagnosed. A consensus report published in The Lancet in December of 2005 (1) stated new statistics about the current prevalence of AD and how it will increase in the future. This report estimates that the number of AD patients will double every 20 years to 42.3 million cases by the year 2020 and to 81.1 million cases by the year 2040. A more conservative estimate of AD prevalence published in Alzheimer's and Dementia in 2005 (2) predicted that the annual cost of AD to Medicare and Medicaid alone would exceed a trillion dollars per year by mid-century and AD will consume 4 of every 10 Medicare dollars.
AD research encompasses many therapeutic approaches that hold promise, but no researcher or company has demonstrated to date that they have an approach that will act in a "disease modifying" role, i.e., addressing the root cause of AD. Current Phase III AD trials are few in number and are generally designed only to demonstrate modest decreases in the rate of cognitive decline among AD patients. Several theories exist regarding appropriate biological targets to use in evaluating new therapies for AD. Many therapies under development depend on the theory that ß-amyloid accumulation (diagnostically known as amyloid plaques) is the cause of AD (3) and that removing it will benefit AD patients. Others examine the depletion of estrogen associated with menopause as a trigger for AD in aging women (4), while another theory suggests that sustained or higher testosterone levels may provide benefit to men with AD (5).
Neurofibrillary tangles associated with the phosphorylation of the protein "tau", long time diagnostic hallmarks of AD, are also being investigated (6). Other scientists, including those at Curaxis, believe that dysregulation of the cell cycle in neurons may promote the neuronal cell death that leads to AD and that other AD-associated events result from that dysregulation (7, 8, 9). However, no consensus exists about the cause of AD or how to slow or stop its progression.
AD is a multifaceted disease that has many biochemical and physiological aspects that provide credence to each of the AD-associated theories mentioned above. Since AD is, first and foremost, a disease of aging and is likely multifactorial, it is reasonable to hypothesize that a biochemical change associated with aging might be the trigger for AD. It would also follow that if one identified the major trigger of AD, then it might be able to explain other aspects of AD. Curaxis’ scientific evidence to date supports the hypothesis that luteinizing hormone (LH) may be associated with several of the pathological processes that result in AD, and Curaxis’ scientific theory is congruent with many mainstream theories regarding how AD arises and how to effectively treat this disease.
This Video is Patrick Smith Of Curaxis Pharmaceutical Corporation - Alzheimer Disease
Lists him as CEO but he is no longer the CEO, but it explains Alzheimer's and the company Brilliantly!
Milestones
Curaxis is committed to its mission of delivering a treatment for halting the progression of Alzheimer's Disease. The Company has made significant strides toward that goal. Some of the more recent accomplishments include:
June 2011 - The Company announced changes to its Board of Directors (the “Board”) and its executive management team to better position the Company for its next phase of growth and development.The new Board has a wealth of experience and comprehensive knowledge of life sciences, operations and strategic management in the area of pharmaceuticals. In addition, the newly appointed Board members have significant experience in the necessary industry arenas to execute the Company’s business plan on an accelerated basis.
July 2010 - The Company announced completion of its reverse merger (the "Merger") with Auto Search Cars, Inc. ("Auto Search"). As a result of the Merger, the company will concentrate exclusively on clinical development of Curaxis' drug pipeline.
October 2009 – Curaxis adds to the management team and board in order to guide the Company through all required development processes. Resources include internal and external experts in basic scientific research, drug development, manufacturing, clinical research and regulatory affairs.
2007 – Curaxis discovers genetic-specific differences in male and female AD brains relevant to treatment methodology.
2007 – Curaxis demonstrates that high doses of Memryte stop or slow tumor growth in numerous cancer cell lines.
2006–2007 – Curaxis demonstrates that Memrye stops tau phosphorylation and oxidative stress.
2006 – Curaxis discovers autocrine-paracrine signaling in neurons and many cancers. Management files applicable patents.
2005 – Working with Durect Corporation, Curaxis initiates first use of its proprietary implant with a unique delivery profile for use in treating Alzheimer’s disease.
2004 – Curaxis files for patents using Memryte and acetcholine inhibitors and NMDA receptor agononists.
2004 – Curaxis initiates an open label extension study for women who complete the one-year, double blind, placebo controlled Phase II trial.
2004 –Our Research Labs in Research Triangle Park commence studies in order to focus on further exploring Curaxis’ basic scientific hypothesis in a number of specific therapeutic targets.
2004 – Curaxis demonstrates that Memryte stops cell cycling-division and apoptosis.
2003 – Curaxis successfully initiates a one-year, double blind, placebo controlled Phase II clinical trial in men, designed to further demonstrate the efficacy and safety of a patented product in the treatment of Alzheimer's Disease.
2003 – Curaxis successfully initiates our double blind, placebo controlled, one year Phase II clinical trial in women to demonstrate the efficacy and safety of a patented product in the treatment of Alzheimer's Disease
The Company continues to build relationships and collaborate on additional research with a network of leading Alzheimer's researchers across the United States and in Australia. These efforts continue to generate important new data that supports our hypothesis and offers a strong scientific case for use of Curaxis’ patented treatment.
Curaxis’ research findings have been published in a number of respected, peer-reviewed journals. Most recently, we reported in the The Journal of Biological Chemistry, a link between the marked increases i n serum LH following menopause/andropause and Aß secretion and deposition in the aging brain.
Working with DURECT Corporation, a leading drug development company, Curaxis has completed initial development of a unique dose and delivery formulation for a patented Alzheimer's treatment.
In collaboration with recognized epidemiologists, Company researchers supported an epidemiological study that offers compelling data and findings, that further support the hypothesis and provides additional evidence of the potential efficacy of Curaxis’ proposed Alzheimer's treatment.
**All research and development of the Company prior to 2009 was carried out under the name Voyager Pharmaceutical Corp. Historical references and literature concerning Voyager Pharmaceutical, its research, developments and operations represent the legacy development of Curaxis Pharmaceutical.
Pipeline
Our therapeutic platform is based on the hypothesis that many diseases of aging may be caused by age-related dysregulation of the hypothalamic-pituitary-gonadal (HPG) axis.
This platform is built on the premise that hormones associated with this axis are beneficial early in life, when they promote growth and development, but are harmful later in life when the mechanism for feedback is compromised, thereby leading to disease processes, including pathologies associated with Alzheimer’s disease and various cancers.
We believe our discovery of a duplicate HPG axis at the cellular level in brain tissue from Alzheimer’s patients and in multiple tumors will enable us to develop significant new treatments for Alzheimer’s disease as well as many cancers.
Our Alzheimer’s Disease Program
Leuprolide acetate, a peptide hormone, has been widely used over the past twenty years for the treatment of a number of hormone-related disorders, most notably prostate cancer and endometriosis and precocious puberty, and has a well-established safety profile. Voyager has conducted extensive preclinical and clinical studies exploring the use of leuprolide acetate for the treatment of Alzheimer’s disease in mild-to-moderate patients.
The results to date are very encouraging and point especially to a potentially significant new treatment for women with Alzheimer’s disease.
Women represent approximately two-thirds of Alzheimer’s patients.
Men present greater challenges in the use of leuprolide to treat Alzheimer’s disease because leuprolide suppresses their production of testosterone, which could necessitate patient self-administration of supplemental testosterone and which can lead to wide swings in testosterone blood serum levels.
Therefore, in the near-term, we plan to concentrate our development efforts on the use of leuprolide acetate to treat women, although we will continue our efforts to better understand mechanisms that might lead to optimum outcomes in men.
Our Oncology Program
We have conducted an extensive preclinical research program in the use of leuprolide acetate to treat a number of cancers, including hor mone refractory prostate cancer, brain cancers, kidney cancer, pancreatic cancer and non-small-cell lung cancer.
Our work in oncology is based on new insights into the growth of cancer cells that have been discovered by our scientists. In particular, our scientific findings relating to autocrine-paracrine signaling and the replication of the hypothalamic-pituitary-gonadal axis (the HPG axis) inside of cancer cells point to a previously unknown mechanism that drives the growth of cancer cells and an entirely new method of attacking those cancer cells; i.e., using high doses of leuprolide acetate to eliminate the gonadotropins that may be driving the growth of those cells.
Our preclinical testing of this new treatment approach has produced extremely encouraging results. In both in vitro and in vivo experiments, we have demonstrated a potentially important new therapy for the treatment of a number of cancers.
We plan to use the same compound for our various cancer Phase II clinical trials as we are using for clinical trials of VP4896. Since we have completed Phase I safety trials of VP4896, we believe that we will be able to commence our clinical programs for various cancers with Phase II clinical trials instead of Phase I safety trials. However, the FDA will have to agree to the commencement of these clinical programs with Phase II clinical trials when we submit our Investigational New Drug Applications, or INDs, to the FDA.
Disease Indication Development Status
Hormone refractory prostate cancer Ready for initiation of proof of concept clinical trials
Adult brain cancers (Glioblastoma, stage III, IV) Ready for initiation of proof of concept clinical trials
Renal cell carcinoma Ready for initiation of proof of concept clinical trials
Pancreatic cancer Ready for initiation of proof of concept clinical trials
Non-small cell lung cancer Preclinical testing to continue
History
Curaxis’ history dates to an insight from the mid-1990’s concerning how changes in various hormone levels impact our health as we age. Most everyone knows that, as we age, our hormone levels change. In particular, it is well known that as we age, levels of estrogen decline precipitously in women, leading to menopause, and levels of testosterone gradually decline in men, leading to andropause. However, while a great deal of research has previously been devoted to the effects of declining estrogen and testosterone on our health, including our mental abilities, Curaxis has taken this research in a broader direction.
Specifically, Curaxis was founded in 2001 (as Voyager Pharmaceutical Corp.) to take a step back from a singular focus on estrogen and testosterone to examine the entire HPG axis, which regulates production of estrogen and testosterone throughout our lives. Curaxis’ initial hypothesis was that changes in the levels of hormones in this axis other than estrogen and testosterone play a key role in various diseases of aging. During 2001 and the years that immediately followed, Curaxis devoted substantial research to testing this hypothesis. Also during 2001, Curaxis was awarded a broad patent covering its unique approach to the treatment of Alzheimer’s.
As a result of Curaxis’ research, it became increasingly clear that one hormone of the HPG axis, called luteinizing hormone or LH, may play a central role in the pathologies that lead to Alzheimer’s as well as other diseases of aging, including many cancers. Levels of LH increase dramatically as women enter menopause and increase substantially in men as they age and testosterone production declines. In numerous preclinical studies, Curaxis’ research showed that these increased levels of LH were likely a key contributor to developing Alzheimer’s.
CURX Partners
Curaxis has engaged a very impressive infrastructure of scientific/technical, medical and legal advisers as strategic partners. This allows the Company to leverage talented individuals who provide key knowledge, expertise and support. A selection of these partnerships is represented by:
• Our collaboration in discovery research with leading Alzheimer's research teams led by George Perry, PhD, Mark A. Smith, PhD http://www.cwru.edu/med/pathology
• Leading patent and FDA legal support from Covington & Burling http://www.cov.com
• Clinical and FDA regulatory support from Bert Spilker & Associates (http://www.bertspilker.com);
• Drug development and delivery support from DURECT Corporation (http://www.durect.com);
• Website and marketing communications support by Sage Communications, LLC. (http://www.cwru.edu/med/pathology)
Case Western Reserve University - Department of Pathology
World-class research is conducted in the Department of Pathology with major emphasis on the following areas and more: cancer biology, infection and immunity, neurobiology/neuropathology, tissue injury and healing, and biomaterials biocompatibility. These emphasis areas are reflected in the three tracks of the Pathology Graduate Program: the Cancer Biology Training Program (CBTP), the Immunology Training Program (ITP) and the Molecular and Cellular Basis of Disease Training Program (MCBDTP). The Pathology Graduate Program provides extensive opportunities for PhD or MD-PhD training in these areas. A separate program leads to the MS degree.
Covington & Burling LLP
Covington & Burling LLP represents clients in cutting-edge technology, litigation, white collar defense, transactional, governmental affairs, international, life sciences and other matters. In responding to the needs and challenges of our clients, our lawyers draw upon the firm’s expertise and experience in a broad array of industries to provide solutions to difficult, complex, and novel problems and issues, whether in litigation, transactions, or regulatory proceedings.
Bert Spilker & Associates
The mission of Bert Spilker & Associates (BS&A) is to provide clients with the highest quality, most cost-effective, and timely pharmaceutical consulting services available. To achieve this goal, Bert has assembled a group of over 150 independent associates who are available to assist him in most aspects of drug discovery, drug development and strategy setting. BS&A strives to build long-term relationships with clients based on knowledge of his clients culture, research, products and services.
Sage Communications Advertising and Public Relations
Sage Communications is a full-service, integrated marketing firm that provides advertising, public relations, and strategic marketing services to clients from across the street to across the globe, from emerging start-ups, to major Fortune 500 companies. Throughout our history, our mission has remained the same: Align marketing strategy to directly impact our clients' bottom line. We are located in Tysons Corner, VA
CURX Recent News
RED HOTT
The 2011 Curaxis Pharmaceuticals Corp Annual Meeting of shareholders will be held on November 8th 2011.
Quote: Curaxis Pharmaceutical Corporation is a specialty pharmaceutical company dedicated to finding cures for major age-related diseases. Curaxis' initial focu s is Alzheimer's Disease (or AD). The lead product is a patented treatment, Memryte, that has shown the potential for treating and halting the progression of this devastating disease.
The Problem
Washington DC, May 19, 2010, A new report from the Alzheimer’s Association, “Changing the Trajectory of Alzheimer’s Disease: A National Imperative” shows that in the absence of disease-modifying treatments, the cumulative cost of care for people with Alzheimer’s from 2010 to 2050 will exceed $20 trillion in today’s dollars.
The new report is not all bad news, however, as it shows that Medicare and Medicaid can achieve dramatic savings - and lives could be significantly improved - with even incremental treatment improvements.
Harry John’s, President & CEO of the Alzheimer’s Association said, “ Today, there are NO treatments that can prevent, delay, slow or stop the progression of Alzheimer’s disease. While the ultimate goal is a treatment that can completely prevent or cure Alzheimer’s, we can see that even modest improvements can have a huge impact.”
Market Need - Curaxis Solution
Currently marketed Alzheimer's drugs target the symptoms of Alzheimer’s disease by enhancing some patients’ cognitive function and general behavior, but generally are not thought to slow progression of the disease.
Only about 50% of patients taking AChEIs (acetylcholinesterase inhibitors - current theory) experience a modest improvement in cognitive function. According to the Alzheimer’s Association, for those patients who show improvement, the benefit typically lasts for only six months to one year.
Based on preclinical and clinical results achieved to date, Curaxis believes that Memryte may substantially slow the progression of Alzheimer's disease and represent a significant clinical improvement over current drugs.
Aug 17, 2011 Curaxis Pharmaceutical Corporation Management Working Through Transition Phase and Evaluating Alternatives
Jun 27, 2011 Curaxis Pharmaceutical Corporation Announces Key Changes to Its Board of Directors and Management Team in Progression Toward Clinical Trials
May 10, 2011 Curaxis Pharmaceutical Corporation Chief Executive Officer Comments on Recent NIH Research
May 5, 2011 Curaxis' Memryte Named One of the Top 100 Drugs in Development Today by R&D Directions
Mar 24, 2011 Curaxis Pharmaceutical Corp. CEO Patrick S. Smith Comments on Recent Prana Research
Mar 10, 2011 Curaxis Pharmaceutical Corp. CEO Patrick S. Smith Comments on Recent New York Times Article "Drug Firms Face Billions in Losses in '11 as Patents End"
Feb 14, 2011 Curaxis Pharmaceutical Corp. to Meet With Ticino Business Development Office in Lugano, Switzerland
Feb 9, 2011 Curaxis Pharmaceutical Corp. Announces New Listing on the Frankfurt Stock Exchange
Feb 7, 2011 Curaxis Pharmaceutical Corp. CEO Patrick S. Smith Comments on Recent Alzheimer's Association Report
Feb 3, 2011 Curaxis Pharmaceutical Management on Roadshow in Europe to Access Capital & Pursue Strategic Partners
CURX Core Management Team
Timothy R. Wright - Chairman and Interim Chief Executive Officer
A seasoned executive with over 25 years of life sciences experience, Timothy Wright has comprehensive operating and strategic management experience, which encompasses pharmaceuticals, medical device, diagnostics and pharmaceutical services. Prior to joining Curaxis as Chairman of the Board and interim Chief Executive Officer, Mr. Wright was a Senior Vice President and President of the pharmaceuticals division at Covidien (Mallinckrodt). He previously served as President of Global Operations at Elan BioPharmaceuticals and spent 17 years at DuPont Merck Pharmaceuticals, where he was classically trained in the pharmaceutical industry. He brings significant global operating and product launch experience and has served on the boards of four public and four private global life sciences companies.
Judith S. T. Geaslen - VP Finance
Judith S. T. Geaslen has been the Company’s Vice President of Finance and Chief Accounting Officer since August 2009 after serving as Corporate Controller and Accountant since July 2004. From March 1999 to April, 2000, Ms. Geaslen served as Vice President and Corporate Controller at Wilmington Trust Corporation, a financial holding company engaged in providing a range of banking and other financial services through its banking and other subsidiaries, and from 1994 to 1999, served as Vice President and Manager of the Asset Review Division. From September 1984 to September 1994, Ms. Geaslen was employed by Ernst & Young, a registered public accounting firm, mostly recently serving as Audit Senior Manager. Ms. Geaslen is a graduate of Saint Mary’s College, Notre Dame, Indiana.
CURX Contact Info
Curaxis Pharmaceutical Corp
1004 Chagford Way
Raleigh, NC 27614
Website: http://www.curaxispharma.com
Phone: 888-919-2873
Email: jgeaslen@curaxispharma.com
twitter: http://twitter.com/#!/curaxispharma
facebook: http://www.facebook.com/pages/Curaxis-P ... 4304105704
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