{"id":399059,"date":"2020-12-14T09:03:31","date_gmt":"2020-12-14T14:03:31","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399059"},"modified":"2020-12-14T09:03:31","modified_gmt":"2020-12-14T14:03:31","slug":"pharmacyte-biotech-begins-physical-testing-of-cypcaps-in-response-to-fda-recommendations-for-its-clinical-trial-product","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/pharmacyte-biotech-begins-physical-testing-of-cypcaps-in-response-to-fda-recommendations-for-its-clinical-trial-product\/","title":{"rendered":"PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product<\/b><\/p>\n<p>LAGUNA HILLS, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nPharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box<sup>\u00ae<\/sup>, announced today that it has commenced additional physical parameter testing of its CypCaps<sup>\u00ae<\/sup> product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA).\n<\/p>\n<p>\nThe FDA has asked that two additional methods be developed to determine the strength of PharmaCyte\u2019s encapsulated cells (CypCaps) to be used in the company\u2019s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). One method involves pressing down on the capsule and measuring either the pressure required for it to burst, or for it to deform. Since the CypCaps are very small, special machinery that can measure such tiny changes has to be used to demonstrate this. The necessary machinery is now being incorporated as a quality control test for the CypCaps.\n<\/p>\n<p>\nThe second method involves letting water flow into the CypCaps, effectively \u201cblowing them up.\u201d The point at which the capsules explode will be used as a quality control parameter.\n<\/p>\n<p>\nPrevious work has shown the pressures and water conditions used in these tests to be well outside of the normal conditions encountered by the capsules inside the human body, so these tests are designed to simulate hypothetical conditions.\n<\/p>\n<p>\nEarlier studies have shown that the capsules do not burst even when placed under very high pressure. Further, even in the very unlikely event that the capsule could break open, the cells inside will be recognized as foreign bodies by the immune system. Also, the encapsulated cells are primed for their suicide since they express the cytochrome P450 gene and thus would be killed by the low dose ifosfamide given as part of the treatment for LAPC.\n<\/p>\n<p>\nThus, these FDA mandated studies can be seen as additional release tests to ensure the reproducibility of the CypCaps.\n<\/p>\n<p>\nPharmaCyte\u2019s Chief Executive Officer, Kenneth L. Waggoner, said, \u201cWe are pleased to announce the development of these two new quality parameters and their incorporation into the quality testing as one of the additional studies requested by the FDA. In the meantime, PharmaCyte continues to work with its partners to address the other issues raised by the FDA that led to the clinical hold.\u201d\n<\/p>\n<p>\nTo learn more about PharmaCyte\u2019s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company\u2019s documentary video complete with medical animations at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.PharmaCyte.com%2FCancer&amp;esheet=52347595&amp;newsitemid=20201214005253&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.PharmaCyte.com%2FCancer&amp;index=1&amp;md5=9d81c97a1ef1ffa91de569b101a21787\">https:\/\/www.PharmaCyte.com\/Cancer<\/a>.\n<\/p>\n<p><b>About PharmaCyte Biotech<\/b><\/p>\n<p>\nPharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as \u201cCell-in-a-Box<sup>\u00ae<\/sup>.\u201d This technology is being used as a platform upon which therapies for several types of cancer and diabetes are being developed.\n<\/p>\n<p>\nPharmaCyte\u2019s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or \u201ccancer-killing\u201d form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient\u2019s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a \u201cbio-artificial liver\u201d and activate the chemotherapy drug at the site of the cancer. This \u201ctargeted chemotherapy\u201d has proven effective and safe to use in past clinical trials and we believe results in little to no treatment related side effects.\n<\/p>\n<p>\nPharmaCyte\u2019s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of the cell lines will be done using the Cell-in-a-Box<sup>\u00ae<\/sup> technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a \u201cbio-artificial pancreas\u201d for purposes of insulin production.\n<\/p>\n<p><b>Safe Harbor<\/b><\/p>\n<p>\nThis press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, our ability to satisfactorily address the issues raised by the FDA in order to have the clinical hold on our IND removed, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward- looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.\n<\/p>\n<p>\nMore information about PharmaCyte Biotech can be found at <span class=\"bwuline\"><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.PharmaCyte.com&amp;esheet=52347595&amp;newsitemid=20201214005253&amp;lan=en-US&amp;anchor=www.PharmaCyte.com&amp;index=2&amp;md5=12f6fceacf7fb96c239c6748da2190ba\">www.PharmaCyte.com<\/a><\/span>. Information may also be obtained by contacting PharmaCyte\u2019s Investor Relations Department.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201214005253r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20201214005253\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201214005253\/en\/<\/a><\/span><\/p>\n<p><b>Dr. Gerald W. Crabtree<br \/>\n<\/b><br \/><b>Investor Relations:<br \/>\n<\/b><br \/>PharmaCyte Biotech, Inc.<br \/>\n<br \/>Investor Relations Department<br \/>\n<br \/>Telephone: 917.595.2856<br \/>\n<br \/>Email: <a rel=\"nofollow\" href=\"mailto:Info@PharmaCyte.com\">Info@PharmaCyte.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> California United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> FDA Diabetes Clinical Trials Stem Cells Other Health Biotechnology General Health Pharmaceutical Health Oncology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201214005253\/en\/610543\/3\/PMCB_logoC100p.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product LAGUNA HILLS, Calif.&#8211;(BUSINESS WIRE)&#8211; PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box\u00ae, announced today that it has commenced additional physical parameter testing of its CypCaps\u00ae product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA). The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte\u2019s encapsulated cells (CypCaps) to be used in the company\u2019s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). One method involves pressing down on the capsule and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/pharmacyte-biotech-begins-physical-testing-of-cypcaps-in-response-to-fda-recommendations-for-its-clinical-trial-product\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product&#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-399059","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product - 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\/pharmacyte-biotech-begins-physical-testing-of-cypcaps-in-response-to-fda-recommendations-for-its-clinical-trial-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product LAGUNA HILLS, Calif.&#8211;(BUSINESS WIRE)&#8211; PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box\u00ae, announced today that it has commenced additional physical parameter testing of its CypCaps\u00ae product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA). The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte\u2019s encapsulated cells (CypCaps) to be used in the company\u2019s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). 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(OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box\u00ae, announced today that it has commenced additional physical parameter testing of its CypCaps\u00ae product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA). The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte\u2019s encapsulated cells (CypCaps) to be used in the company\u2019s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). 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