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Acute Myeloid Leukemia (AML) Therapeutics Pipeline Poised to Grow With Update Pharma's Rediscovery of UPI-928  
8/13/2013 8:46:38 AM

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RENO, Nev., Aug. 13, 2013 /PRNewswire/ -- Update Pharma, Inc. ("Update") announced that the company will make an oral presentation entitled "Re-Discovering UPI-928" at the 3rd World Conference on Cancer Science and Therapy on October 21, 2013 in San Francisco, CA.

Dr. John Rothman, CEO, will give an overview of the history of UPI-928 and recent data which supports the re-development of the small molecule, which was lost to the world following extensive clinical development. An anthracene with a unique structure related to, but different from, anthracyclines, UPI-928 lacks the dose-limiting cardiotoxicity that has historically limited the use of these drugs. UPI-928 has shown a clinical activity profile similar to anthracyclines, and thus has broad potential utility in the clinic.

In the 1980's UPI-928 was developed in 44 phase 1, 2 and 3 clinical trials, including 33 clinical trials at the National Cancer Institute, and was approved for marketing in France for the treatment of acute myeloid leukemia (AML). However, the pharmaceutical company that developed the agent was sold at about the time of the approval, and the international pharmaceutical company that acquired the portfolio did not have a market presence in oncology. And so development was stopped and UPI-928 was never launched. The acquiring pharmaceutical company was, in turn, sold shortly thereafter to a 3rd pharmaceutical company. Thus, despite a safety profile that was superior to related drugs and an extensive body of peer-reviewed literature documenting clinical activity in a number of indications, UPI-928 was never marketed and was eventually forgotten.

Beyond its cytotoxic activity, more recent data has shown that UPI-928 also has significant immunologic and genomic mechanisms of action which contribute to the clinical utility of the agent. These include, for example, the ability to activate macrophages sufficient to eliminate tumors in an allogeneic model and the ability to bind DNA in a manner that displaces telomerase binding proteins and blocks the action of telomerase, enabling immortal cells to regain a mortal phenotype. This multi-factorial attack on cancer may ultimately make UPI-928 suited for combinatorial regimens in which chemotherapeutic agents are combined with immunologically active and/or genomically active agents.

Update has filed extensive for extensive patent protection on UPI-928 based upon new mechanisms of action, new formulations, and methods of use that include combinatorial regimens.

Dr. Rothman commented, "This is a unique situation, and one I never expected to encounter. It is unheard of to find a drug with such extensive clinical development and a large body of published peer reviewed clinical trials that document a tolerable safety profile and good clinical activity, including a marketing approval; and yet not no-one has marketed the agent. Obviously, UPI-928 is greatly de-risked, allowing Update to potentially develop this agent much more quickly than would otherwise be the case. Because UPI-928 has documented activity against a range of tumor types, including leukemia, lymphoma, ovarian cancer, and refractory breast cancer we believe UPI-928 has the potential to also be re-developed in other important indications. AML represents our initial development focus as the agent has already been approved for marketing in France for this indication. It is particularly attractive that UPI-928 appears to be less toxic than related existing front line therapies," said Dr. Rothman.

About UPI-928

A major international pharmaceutical company originally developed UPI-928 based on preclinical data that revealed a high degree of activity in animal models and a safety profile that was superior to related agents. From the early 1980's through the early 1990's over 40 phase 1, 2 and 3 clinical trials were conducted with this agent around the world, including extensive study at the National Cancer Institute (NCI).

About twenty years ago it was approved in France. However, following the sale of the parent company and the subsequent sale of the purchasing company, the drug was never marketed, despite having been shown to possess a tolerable safety profile and therapeutic activity in various cancer indications, including leukemia, lymphoma, ovarian cancer and refractory, metastatic breast cancer. UPI-928 is an unusual agent with several mechanisms of action, including direct cytotoxic actions, immunologic mechanisms, and genomic effects.

About Acute Myeloid Leukemia (AML)

AML is generally a disease of older people, characterized by remission and relapse. It is devastating with survival of ~ 1-1.5 years following first line treatment and ~ 6 months after second line treatment.

According to the World Health Organization, acute myeloid leukemia is expected to be more prominent in the developed world due to genetic and environmental factors. Radiation exposure is the primary cause of all the types of acute myeloid leukemia. Worldwide, a total of 62,226 new cases were recorded in 2010, with 95,211 predicted new cases for 2015 and 129,837 predicted new cases in 2020.

"The Acute Myeloid Leukemia (AML) therapeutics market was USD 239.3 million in 2011 and this market is forecasted to reach USD 731.1 million in 2018. Future AML therapeutics market shows unprecedented growth at a CAGR [compound annual growth rate] of 17.3 % from 2011 to 2018 while in the past, growth rate was only 2.9% from 2005 2010."

Acute Myeloid Leukemia (AML) Therapeutics Market - Global Industry Size, Share, Trends, Analysis And Forecasts 2012 2018. Transparency Market Research (http://www.transparencymarketresearch.com/acute-myeloid-leukemia-therapeutics-market.html)

About Update Pharma Inc.

Update Pharmaceutical company, Inc. is a clinical-stage small molecule company focused on developing overlooked or underutilized anti-cancer drugs. Our lead compound UPI-928 was originally developed more than 20 years ago. It has demonstrated clinical activity and good tolerability in acute myeloid leukemia (AML) and other oncology indications including refractory breast cancer, myeloma, and ovarian cancer.

Forward Looking Statements

Certain statements in this Press Release are "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risk factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include the risk for the Company to complete its development work, as well as the risks inherent in commercializing a new product (including technology risks, market risks, financial risks and implementation risks, and other risks and uncertainties affecting the Company), as well as other risks that have been disclosed by us and are customarily disclosed in SEC filings of publicly traded pharmaceutical companies. We disclaim any intention or obligation to revise any forward-looking statements, including, without limitation, financial estimates, whether as a result of new information, future events, or otherwise.

For further information, please visit www.updatepharma.com; or contact John Rothman, PhD, CEOat Email or 908-236-9513.

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SOURCE Update Pharma, Inc.



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