Protagonist Announces Results of Large-Scale Analysis of Current Treatment Patterns Revealing Significant Opportunity to Improve the Standard of Care for Patients with Polycythemia Vera Across Broad Population Categories
"This analysis shows that patients with polycythemia vera are often not receiving appropriate treatment, thereby potentially exposing these patients to life-threatening risks such as the risk of experiencing thrombotic events," commented Srdan Verstovsek, M.D, Ph.D., research co-author and Director of the
The large scale analysis with 4,264 patients analyzed indicated that only 22 percent of a representative population of patients had hematocrit values maintained below the NCCN recommended guideline level of 45 percent. A majority of patients in the high risk population received treatment with phlebotomy alone, and hematocrit levels were often above recommended levels, and nearly half (49 percent) of patients had hematocrit levels substantially above recommended levels (above 50 percent) at least once during the observation period. Consistent with inadequate hematocrit control, a high incidence of thrombotic events was observed in patients receiving treatment.
"Our interpretation of these results is that there is a significant unmet need for effective treatment options for patients with polycythemia vera," commented
A Phase 2 study of PTG-300 in patients with polycythemia vera is currently enrolling subjects. Additional information is available at http://ptg300pvstudy.com/.
About Polycythemia Vera
Polycythemia vera is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. There are an estimated 100,000 patients with polycythemia vera in the
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Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential benefits of polycythemia vera treatments. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with Janssen, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the
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