CURX ~Curaxis Pharmaceutical Corporation
Curaxis Pharmaceutical Corporation is an emerging specialty pharmaceutical company with a hormone drug product candidate for the treatment of Alzheimer's disease and multiple cancers. Curaxis' therapeutic platform is based on the hypothesis that many diseases of aging may be caused by age-related changes in the function of the hypothalamic-pituitary-gonadal (HPG) axis. The HPG axis is a hormonal endocrine feedback loop that controls development, reproduction and aging in animals. This drug development platform is built on the premise that hormones associated with this feedback loop 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.
CURX Security Details
Curaxis Pharmaceutical Corporation is a fully reporting SEC company, publicly traded on the OTC Market under the symbol, "CURX"
, and within the OTCQB market tier. As such, Business, operational and financial information on CURX is fully transparent and available to public view.
for more information.
Market Value1 $5,357,650 a/o Nov 03, 2011
Shares Outstanding 76,537,861 a/o Aug 11, 2011
Float 16,238,300 a/o Sep 15, 2010
Authorized Shares 480,000,000 a/o Aug. 12 2011
Par Value 0.0001
(per otcmarkets) Transfer Agent
Direct Transfer, LLC.
500 Perimeter Park Drive Suite D
Morrisville, NC, 27560
www.issuerdirect.com [email protected] 10Q reported Aug 12, 2011 period ending Jun 30, 2011 http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8096721
Shareholders of Record: 41 a/o Apr 15, 2010
SIC - Industry Classification: 2834 - Pharmaceutical preparations
Incorporated In: NV, USA
Year of Inc.: 2008 and On July 30, 2010, the Company entered into an agreement and plan of merger with Curaxis Pharmaceutical Corporation, a Nevada corporation formed solely for the purpose of a name change. Pursuant to the Short-Form Merger, the Company changed its name to Curaxis Pharmaceutical Corporation ("Curaxis" or the "Company")
In February 2011, the Company was granted approval and listed its stock to trade on the Frankfurt stock exchange ("FSE") under the symbol 8CX to expand its global capital markets access. Security Notes
Capital Change=shs increased by 91 for 1 split. Ex-date=01/12/2010. Rec date=12/09/2009. Pay date=01/11/2010 Company Notes
Formerly=Auto Search Cars, Inc. until 9-2010
Source: otcmarket.com, www.bloomberg.com, www.finance.yahoo.com
CURX Products & Services
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.
CURX 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.
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!
CURX 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.
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.
Developing A Focus
Having determined that high levels of LH represented a potential cause of Alzheimer's, Curaxis then focused on using leuprolide acetate, which eliminates or dramatically reduces LH levels, as a treatment for Alzheimer's. Curaxis' focus on LH followed two parallel paths.
First, in 2002, Curaxis entered into an agreement with Durect Corporation to develop a proprietary implant that would release leuprolide acetate at targeted levels over a two month dosing period. Work on development of this implant commenced in 2002 and culminated in 2005 with a successful Phase 1 trial of the safety and tolerability of the implant.
Second, because leuprolide acetate had been used for many years to treat other diseases, including prostate cancer, in early 2003 Curaxis commenced a Phase 2 clinical trial to treat mild-to-moderate Alzheimer's in women, using a commercially available dose of leuprolide. In addition, in late 2003 Curaxis commenced a Phase 2 clinical trial to treat mild-to-moderate Alzheimer's in men, again using a commercially available dose of leuprolide.
This parallel path enabled Curaxis to significantly shorten development for its Alzheimer's candidate. As a result, by mid-2005, Curaxis had successfully completed dosing in the Phase 1 trial of its proprietary implant developed with Durect, which Curaxis calls Memryte, and had also completed its Phase 2 trial of leuprolide in women. The results of both of these trials were encouraging and Curaxis began making plans for Phase 3 trials of Memryte. Based on FDA filings and a meeting with the FDA in August 2005, Curaxis launched its Phase 3 trials of Memryte in September 2005.
Also in September 2005, Curaxis (then Voyager Pharmaceutical) filed for its initial public offering, in order to raise sufficient funds for its Phase 3 trials. Based on the strength of its preclinical and clinical data and its management, it was anticipated that a successful IPO would follow later in 2005. Unfortunately, a leading contributor to the research and a significant shareholder of the company took medical leave at the height of these efforts. Complications associated with his illness and absence forced the company to withdraw from the IPO process.
The results of the Phase 2 clinical trial in men were obtained in mid-2005. However, although there were positive signals in those results, the results were confounded by the need to provide supplemental testosterone to men on active treatment in the trial.
During 2006, Curaxis renewed its efforts to obtain private capital to complete its Phase 3 trials. Although it enjoyed some success, it was unable to obtain the full amount needed and was forced to terminate the Phase 3 trials in late 2006. During the remainder of 2006 and 2007, Curaxis worked to obtain the maximum amount of data from these terminated trials. Although the data was incomplete due to the early termination of the trials, the date obtained provided further support for the use of leuprolide to treat mild-to-moderate Alzheimer's, particularly in women.
During 2008 and 2009, Curaxis has regrouped in its efforts to move forward with Memryte. Although Curaxis was unable to make progress in the clinical development of Memryte during this period, the field of Alzheimer's research was not static during this period. A number of Phase 3 Alzheimer's trials, which focused on a target called beta amyloid to treat Alzheimer's, failed to meet their endpoints during 2007-2009. Curaxis has long believed that a focus solely on beta amyloid as a target to treat Alzheimer's is incorrect and the failures of these trials support that view. Most importantly, Curaxis believes that the failure of these trials will broaden acceptance of other approaches to treating Alzheimer's, including Curaxis' approach.
In 2009, Curaxis entered into a series of agreements with Southridge Business Solutions Group ("Southridge") in order to restructure its balance sheet and establish a trading market for its common stock. Under the terms of those agreements, Southridge assisted Curaxis in negotiating settlements with its creditors to eliminate or substantially reduce and defer its trade debt. To date, Curaxis has realized reductions in excess of $6 million in liabilities as the result of the combined efforts. In addition, Southridge assisted Curaxis in securing a $25 million equity facility under which the Company can periodically, over a period of three years, sell up to $25 million of its common stock to an affiliate of Southridge. On December 8, 2010, the Company filed a Registration Statement on Form S-1 to register 13,000,000 shares of common stock to be reserved for issuance under the Equity Line Facility.The proceeds of the equity facility will be used, in part, to fund the next steps in the Company's clinical development plan.
In July, 2010, Curaixs completed a reverse merger into a public shell Corporation. As a result, the Company's common stock is now traded on the OTC Quote Board under the symbol "CURX." In addition, Curaxis began trading on the Frankfurt Stock Exchange under the ticker "8CX" on February 7, 2011.
On June 27, 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 all of the necessary industry arenas to execute the Company's business plan on an accelerated basis.
The Board is in the process of completing a comprehensive analysis of the financial position of the Company and is evaluating potential funding alternatives. In addition, the Board has been focused on several remaining transition items including, but not limited to, the efficient processing of capital transactions for pre-merger shareholders, the scientific evaluation of the Company's inventory of pre-clinical and clinical data and related intellectual property and, the development of strategic alternatives.
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.aboutsage.com) 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
Curaxis 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.
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.