{"id":394105,"date":"2020-12-07T07:33:08","date_gmt":"2020-12-07T12:33:08","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=394105"},"modified":"2020-12-07T07:33:08","modified_gmt":"2020-12-07T12:33:08","slug":"bellicum-reports-clinical-hold-placed-on-bpx-601-phase-1-2-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bellicum-reports-clinical-hold-placed-on-bpx-601-phase-1-2-clinical-trial\/","title":{"rendered":"Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1\/2 Clinical Trial"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">HOUSTON, Dec.  07, 2020  (GLOBE NEWSWIRE) &#8212; Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1\/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company. The clinical investigator and Bellicum classified the patient death as unrelated to BPX-601 and rimiducid.<\/p>\n<p>The company plans to work diligently with the FDA to address the agency\u2019s questions and fulfill the requirements for resuming the trial. The clinical hold does not affect the company\u2019s plans to initiate enrollment in the Phase 1\/2 clinical trial of BPX-603, a dual switch GoCAR-T<sup>\u00ae<\/sup>, in patients with HER2+ solid tumors by the end of the year.<\/p>\n<p>\n        <strong>About BPX-601 <\/strong>\n      <\/p>\n<p>BPX-601, the company\u2019s first GoCAR-T<sup>\u00ae<\/sup>\u00a0product candidate, incorporates iMC, Bellicum\u2019s inducible co-activation domain. iMC (inducible MyD88\/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, production of immunomodulatory cytokines and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for pancreatic and prostate tumors expressing prostate stem cell antigen (PSCA).<\/p>\n<p>\n        <strong>About Bellicum Pharmaceuticals<\/strong>\n      <\/p>\n<p>Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company\u2019s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum\u2019s GoCAR-T<sup>\u00ae<\/sup>\u00a0product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=x3Ts29WhRR-mWx87esEIjIZWKwGzeEdFkUdIXI-6zbaHjP-0jQU9ecKPP72_TBjXFuDYkPTA32wRmLHCUx5UqQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.bellicum.com<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as \u201cpredicts,\u201d \u201cbelieves,\u201d \u201cpotential,\u201d \u201cproposed,\u201d \u201ccontinue,\u201d \u201cdesigned,\u201d \u201cestimates,\u201d \u201canticipates,\u201d \u201cexpects,\u201d \u201cplans,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201cshould\u201d or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our efforts with the FDA to resume the BPX-601 clinical trial and our plans to initiate enrollment in the Phase 1\/2 clinical trial of BPX-603. Various factors may cause differences between Bellicum\u2019s expectations and actual results as discussed in greater detail under the heading \u201cRisk Factors\u201d in Bellicum\u2019s filings with the Securities and Exchange Commission, including without limitation our quarterly report on Form 10-Q for the three months ended September 30, 2020 and our annual report on Form 10-K the year ended December 31, 2019. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.<\/p>\n<p>Source: Bellicum Pharmaceuticals<\/p>\n<p>Investors:<br \/>Robert H. Uhl<br \/>Managing Director<br \/>Westwicke ICR<br \/>858-356-5932<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=eUFBalpxVNFvImzxLMfs5aJ6hBTvGw7kTSnRfIij9soBVPcsAN4ZczWLIe1Ilq503dzP5kG9cJL3aAWR8P5SrSQa2iyYutCiTAiRaixt7XU=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Robert.uhl@westwicke.com<\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA5NzE1NSMzODU3NDQwIzIwMTY2OTU=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/27569ed4-f82b-45bc-bf2c-2379d306a977\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>HOUSTON, Dec. 07, 2020 (GLOBE NEWSWIRE) &#8212; Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1\/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company. The clinical investigator and Bellicum classified the patient death as unrelated to BPX-601 and rimiducid. The company plans to work diligently with the FDA to address the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bellicum-reports-clinical-hold-placed-on-bpx-601-phase-1-2-clinical-trial\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1\/2 Clinical Trial&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-394105","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1\/2 Clinical Trial - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bellicum-reports-clinical-hold-placed-on-bpx-601-phase-1-2-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1\/2 Clinical Trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"HOUSTON, Dec. 07, 2020 (GLOBE NEWSWIRE) &#8212; Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1\/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company. The clinical investigator and Bellicum classified the patient death as unrelated to BPX-601 and rimiducid. 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(NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1\/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company. The clinical investigator and Bellicum classified the patient death as unrelated to BPX-601 and rimiducid. 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