{"id":3860,"date":"2020-05-01T07:40:38","date_gmt":"2020-05-01T07:40:38","guid":{"rendered":"http:\/\/maadhouze.com\/?p=3860"},"modified":"2020-05-01T07:40:38","modified_gmt":"2020-05-01T07:40:38","slug":"neuraptive-therapeutics-announces-fda-clearance-of-ind-application-for-ntx-001","status":"publish","type":"post","link":"https:\/\/theblogonline.com\/?p=3860","title":{"rendered":"Neuraptive Therapeutics Announces FDA Clearance Of IND Application For NTX-001"},"content":{"rendered":"

\u2022 <\/span>NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves<\/span><\/span><\/em><\/p>\n

\u2022 <\/span>Neuraptive<\/span><\/span> will conduct a Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Patients with Acute Single Transected Peripheral Nerve Injuries of the Upper Extremities<\/span><\/span><\/em><\/div>\n


\nNeuraptive<\/span><\/span> Therapeutics, Inc. (<\/span><\/span>Neuraptive<\/span><\/span>), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs in the treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has cleared <\/span><\/span>Neuraptive’s<\/span><\/span> Investigational New Drug (IND) application for NTX-001 in patients with acute single transected PNI. <\/span><\/span><\/p>\n

“We are pleased to have received clearance for the company\u2019s first IND, and are excited to initiate the trial later this year,” said Evan <\/span><\/span>Tzanis<\/span><\/span>, Executive Vice President and Head of Research and Development. “We look forward to working with investigators as we advance <\/span><\/span>Neuraptive\u2019s<\/span><\/span> NTX-001 into the clinic for the treatment of peripheral nerve injuries.” <\/span><\/span><\/p>\n

Peripheral nerve injuries resulting in surgeries are common, occurring in more than 600,000 patients annually in the United States, with approximately 80% of nerve injuries occur in the upper extremities. <\/span><\/span>Neuraptive\u2019s<\/span><\/span> Phase 2 study will evaluate the safety and efficacy of NTX-001 versus the current standard of care in upper extremity injuries. NTX-001 is being developed in the U.S. via the FDA 505 (b) (2) development pathway, in which the components contained in the product are present in existing, approved drug products, allowing for the potential of a more streamlined development program. <\/span><\/span><\/p>\n

“Current interventions do not prevent the irreversible degeneration that occurs within 48 to 72 hours following injury. We believe that NTX-001 has the potential to diminish or prevent this degenerative process so that nerves recover more quickly, and patients can avoid disabilities that commonly result from these types of nerve injuries,” said Ivan Gergel, MD, Executive Chairman of the Board of <\/span><\/span>Neuraptive<\/span><\/span>. “We are hopeful that NTX-001 can be a revolutionary treatment for physicians to offer their patients undergoing PNI repairs.”<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

\u2022 NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves \u2022 Neuraptive will conduct a Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Patients with Acute Single Transected Peripheral Nerve Injuries of the […]<\/p>\n","protected":false},"author":1,"featured_media":3861,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2456],"tags":[2569,2570,2568,2571,2572],"class_list":["post-3860","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","tag-fda","tag-ind-application","tag-neuraptive-therapeutics","tag-ntx-001","tag-peripheral-nerve-injuries"],"_links":{"self":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3860"}],"collection":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3860"}],"version-history":[{"count":1,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3860\/revisions"}],"predecessor-version":[{"id":3862,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/posts\/3860\/revisions\/3862"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=\/wp\/v2\/media\/3861"}],"wp:attachment":[{"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/theblogonline.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}