CypCaps (encapsulated live cells converting ifosfamide) / PharmaCyte - LARVOL DELTA

PharmaCyte Biotech Announces More Positive Tests Results for Its Pancreatic Cancer Clinical Trial Product Candidate to Satisfy FDA Requirements (Businesswire) - "This time the study evaluated the potential toxicity of the capsule component of our CypCaps™ clinical trial product candidate. We are pleased to announce that there was no evidence of toxicity in this animal study in any of the parameters examined and that the study confirms previous data that the capsule material is inert.'...The analyses revealed that none of the mice died or showed any clinical signs of toxicity or gross pathological changes as compared to control mice."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PharmaCyte Biotech to Accelerate Preparations for Start of Pancreatic Cancer Clinical Trial (Businesswire) - "PharmaCyte Biotech, Inc...announced that PharmaCyte has decided to accelerate preparations for the start of its Phase 2b clinical trial in locally advanced, inoperable pancreatic (LAPC) using its CypCaps^TM clinical trial product...'we are ideally situated to begin the work necessary to enroll the first patient now to run parallel with the work being done to get the clinical hold lifted.'....The work to enroll the first patient includes finalizing the (i) clinical trial protocol; (ii) pharmacy manual; (iii) investigator’s brochure; (iv) angiography manual; (v) informed consent; and (vi) drug product label."

New P2b trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PharmaCyte Biotech Successfully Completes 24-Month Stability Study of Its Clinical Trial Product Candidate (Businesswire) - "PharmaCyte Biotech, Inc....that it has successfully completed a 24-month product stability study required by the U.S. Food and Drug Administration (FDA) for its clinical trial product candidate, CypCaps™. The significance of this timepoint is that CypCaps has now demonstrated that it has a shelf life of at least 24 months when stored at -80oC....Notably, over the entire 24-month period, there was no significant change in the number and viability of the encapsulated cells, or, most importantly, in the biological activity that is key to activating the anti-cancer mechanism PharmaCyte uses for its cancer therapy. The successfully completed stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data obtained from the study will form part of the updated package of information that will be provided to the FDA, together with data from additional studies requested by this regulatory agency."

Clinical • Oncology

PharmaCyte Biotech Reports Third Quarter Financial Results and Operational Highlights (Businesswire) - "PharmaCyte Biotech, Inc...announced today the financial and operational results for its third quarter ended January 31, 2022, and provided an overview of recent operational highlights (PharmaCyte’s Fiscal Year begins May 1 and ends April 30)....As of January 31, 2022, PharmaCyte’s cash balance and total assets were approximately $87 million."

Commercial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PharmaCyte Biotech Updates Status of Investigational New Drug Application to FDA (Businesswire) - "PharmaCyte Biotech, Inc...provided an update on PharmaCyte’s activities to lift the U.S. Food and Drug Administration’s (FDA) clinical hold on PharmaCyte’s treatment for locally advanced, inoperable pancreatic cancer (LAPC). After submission of an initial Investigational New Drug Application (IND), the FDA requested additional studies and information as a prerequisite for approval of PharmaCyte’s IND. A number of additional studies and assays have already been completed; several others are quite lengthy and are underway or are slated to begin soon. As each study and assay is completed, the results are being compiled and will make up PharmaCyte’s complete IND submission package to the FDA."

FDA event • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

PharmaCyte Biotech Successfully Completes 36 Month Master Cell Bank Stability Study (Businesswire) - "PharmaCyte Biotech, Inc...announced that it has successfully completed a 36-month stability study of the cells from its Master Cell Bank (MCB). These cells will be encapsulated and then used to treat locally advanced, inoperable pancreatic cancer (LAPC). This stability study is one of the items that the U.S. Food and Drug Administration (FDA) requires PharmaCyte to complete for its clinical trial product, CypCaps™, in an effort to lift the FDA’s clinical hold. This means that the cells used to produce the CypCaps have a shelf life of at least 36 months when stored in a vapor phase of liquid nitrogen."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Launches Malignant Ascites Program with Commencement of Pivotal Preclinical Study (Businesswire) - "PharmaCyte Biotech, Inc...announced today the commencement of a pivotal study to determine if the treatment PharmaCyte uses for locally advanced, inoperable pancreatic cancer—Cell-in-a-Box (CypCaps™) combined with the cancer killing prodrug ifosfamide—can also delay the rate of production and accumulation of malignant ascites. This is fluid that accumulates in the abdominal cavity from various cancers."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Releases More Positive Results From FDA-Required Biocompatibility Tests (Businesswire) - “PharmaCyte Biotech…announced today the results of a second U.S. Food and Drug Administration (FDA)-required test of biocompatibility of its CypCaps™ product for pancreatic cancer, which showed that the empty capsule material is 'non-hemolytic’…Two different methods were used for the evaluation: (i) a direct contact method where the capsule material was mixed with rabbit blood; and (ii) an indirect method where the capsule material was extracted with saline and mixed with rabbit blood. The hemolytic index of both the empty capsules and the extraction material was such that the Contract Research Organization concluded that the test item in both the direct contact method and indirect contact method is considered as ‘non-hemolytic.”’

Clinical data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Announces Positive Results of Biocompatibility Study for FDA (Businesswire) - "PharmaCyte Biotech, Inc...announced today the first test results of the biocompatibility studies of its CypCaps™ clinical trial product candidate....'We are pleased to report that we have received the results from the first of these studies showing that, as expected, the capsule material does not activate a major line of the human body’s innate defense - the complement system.'"

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Successfully Completes 1 Year Stability Study (Businesswire) - "PharmaCyte Biotech, Inc...announced today that it has successfully completed the twelve-months product stability testing required by the U.S. Food and Drug Administration (FDA) for its CypCaps™ final clinical trial product. This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer upon the FDA lifting the clinical hold on PharmaCyte’s Investigational New Drug Application....Upon analysis after 12 months in storage at -80oC, the unfrozen CypCaps™ product passed all of the specified tests, including cell viability, enzyme activity and cell potency as well as pH, label check, capsule appearance, and integrity."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Begins DNA Sequence and Stability Studies in Response to FDA Requests for its Clinical Trial Product (Businesswire) - “PharmaCyte Biotech…announced today that it has commenced additional studies to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps® product for pancreatic cancer and the stability of the sequences, in line with the requests provided by the U.S. Food and Drug Administration (FDA)…The site of integration of the DNA encoding of the cytochrome P450 enzyme; and (ii) the data on the stability of the cells, even before they are encapsulated using the Cell-in-a-Box® to produce the CypCaps® product.”

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product (Businesswire) - "PharmaCyte Biotech, Inc...announced today that it has commenced additional physical parameter testing of its CypCaps® 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’s encapsulated cells (CypCaps) to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC)..."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer