{"id":12625,"date":"2020-11-18T14:54:05","date_gmt":"2020-11-18T14:54:05","guid":{"rendered":"http:\/\/bioventuspub.wpengine.com\/bioventus-receives-authorization-to-proceed-under-investigational-new-drug-application-for-clinical-trial-of-placental-tissue-particulate-ptp-001-for-the-treatment-of-knee-oa\/"},"modified":"2020-11-18T14:54:05","modified_gmt":"2020-11-18T14:54:05","slug":"bioventus-receives-authorization-to-proceed-under-investigational-new-drug-application-for-clinical-trial-of-placental-tissue-particulate-ptp-001-for-the-treatment-of-knee-oa","status":"publish","type":"post","link":"https:\/\/www.bioventus.com\/fr\/bioventus-receives-authorization-to-proceed-under-investigational-new-drug-application-for-clinical-trial-of-placental-tissue-particulate-ptp-001-for-the-treatment-of-knee-oa\/","title":{"rendered":"Bioventus Receives Authorization to Proceed Under Investigational New Drug Application for Clinical Trial of Placental Tissue Particulate (PTP-001) for the Treatment of Knee OA"},"content":{"rendered":"<p><strong>DURHAM, NC<\/strong><strong> \u2013 November 18, 2020 \u2013 <\/strong><a href=\"http:\/\/www.bioventus.com\/fr\/\">Bioventus<\/a>, a leader in Solutions For Innovative Healing, received authorization to proceed under its investigational new drug (IND) application from the US Food and Drug Administration (FDA), allowing it to proceed to <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04632966?term=NCT04632966&amp;draw=2&amp;rank=1\">clinical trials of PTP-001<\/a>. PTP-001 (commercial trade name <a href=\"http:\/\/www.motys.com\">MOTYS<\/a>\u2122) is a placental tissue particulate comprised of amnion, chorion and umbilical cord from full-term, healthy births and is provided sterile in micronized form.<\/p>\n<p>Bioventus plans to evaluate the safety and efficacy of PTP-001 to treat osteoarthritis of the knee through an open-label, dose-escalation study. The study is expected to enroll 20 patients, 40-80 years of age and test two doses (low and high dose) of PTP-001 in two unique cohorts of 10 patients each. Each patient will receive a single injection of PTP-001.<\/p>\n<p>\u201cThis submission and open IND for PTP-001, the first for Bioventus, is a monumental milestone in the history of our young company. We are proud of our submission team and are ready to begin enrolling patients and administering PTP-001 in Phase 1 of our study,\u201d said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus.<\/p>\n<p>\u201cThis study will assess clinical safety of two doses of PTP-001, both at or higher than those often utilized today by physicians. Our goals are to begin to clarify the potential dose for PTP-001 and to determine whether PTP-001 could fulfill an unmet need for physicians and their patients with knee osteoarthritis,\u201d she added.<\/p>\n<p><strong>About Bioventus<br \/>\n<\/strong>Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit <a href=\"http:\/\/www.bioventus.com\/fr\/\">www.bioventus.com<\/a> and follow the company on <a href=\"https:\/\/www.linkedin.com\/company\/bioventus\/\">LinkedIn<\/a> and <a href=\"https:\/\/twitter.com\/BioventusGlobal\">Twitter<\/a>.<\/p>\n<p><strong>Media Contact:\u00a0<\/strong>Thomas Hill, &nbsp;,\u00a0thomas.hill@bioventusglobal.com<\/p>\n<p>Bioventus and the Bioventus logo are registered trademarks and MOTYS is a trademark of Bioventus LLC.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>DURHAM, NC \u2013 November 18, 2020 \u2013 Bioventus, a leader in Solutions For Innovative Healing, received authorization to proceed under [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-12625","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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