PharmaCyte Biotech, Inc. - PMCB STOCK NEWS

PharmaCyte Biotech, Inc. (NASDAQ: PMCB) has announced a detailed analysis of the integration site of the cytochrome P450 2B1 gene in its pancreatic cancer product candidate, CypCaps™. Previous studies indicated the gene was located on human chromosome 9. The new findings confirm the structure of the transgene sequence and demonstrate genetic stability in cell growth. PharmaCyte aims to develop cellular therapies for cancer and diabetes using its Cell-in-a-Box® technology, which has been effective in previous clinical trials.

PharmaCyte Biotech (NASDAQ: PMCB) provided an update on its efforts to lift the FDA's clinical hold on its treatment for locally advanced pancreatic cancer. Following an Investigational New Drug Application, the FDA requested additional studies. PharmaCyte has completed several studies and is actively engaging with experts and organizations to compile required data. Challenges include global supply chain issues affecting study timelines. Key updates include the addition of regulatory expertise, successful completion of product stability studies, and commencement of various biocompatibility studies.

PharmaCyte Biotech (NASDAQ: PMCB) announced its participation as a presenting company at the virtual H.C. Wainwright BioConnect Conference from January 10-13, 2022. CEO Kenneth L. Waggoner will discuss the company's business and product pipeline during the presentation, available on-demand starting January 10, 2022. Additionally, PharmaCyte plans to release an update on its clinical hold by the FDA for its Phase 2b trial targeting locally advanced pancreatic cancer. More information is available on their website.

PharmaCyte Biotech (NASDAQ: PMCB) announced findings from a recent study confirming that the capsule material in its CypCaps pancreatic cancer product is non-toxic to encapsulated cells. The evaluation showed the capsule material is bio-inert, supporting treatment for locally advanced, inoperable pancreatic cancer. Conducted in compliance with international standards, the study used mouse fibroblast cells to assess cytotoxicity, yielding positive results. This adds to PharmaCyte's goal of developing effective cancer and diabetes therapies using its unique Cell-in-a-Box technology.

PharmaCyte Biotech (NASDAQ: PMCB) has completed a significant 36-month stability study of cells from its Master Cell Bank, crucial for its treatment of locally advanced pancreatic cancer (LAPC). This study, required by the FDA to lift a clinical hold on its CypCaps product, confirms that the cells are stable and viable when stored in liquid nitrogen. The ongoing research will continue to assess the maximum shelf life of these cells. PharmaCyte plans to include findings from this study in its Complete IND Submission to the FDA.

PharmaCyte Biotech (NASDAQ: PMCB) reported its financial results for the second quarter ending October 31, 2021. The company has approximately $87 million in cash on hand and completed a $15 million public offering and a $70 million registered direct offering. Key operational highlights include advancements in its cancer and diabetes programs, stability of CypCaps™ after 18 months, and positive biocompatibility study results. Total stockholder equity rose by $86 million from July 31, 2021, while operating expenses increased due to Nasdaq uplisting and R&D investments.

PharmaCyte Biotech, Inc. (NASDAQ: PMCB) announced the successful completion of a detailed analysis of the cytochrome P450 2B1 gene integration site from its augmented HEK293 cell clone, a significant step toward lifting the FDA's clinical hold on its Investigational New Drug Application (IND) for treating locally advanced pancreatic cancer. CEO Kenneth L. Waggoner expressed satisfaction with the challenging sequencing assay's completion, which confirms the cells' integrity. This progress is crucial as the company moves closer to clinical trials for its novel cancer therapy.

PharmaCyte Biotech (NASDAQ: PMCB) has announced a pivotal study targeting malignant ascites associated with locally advanced, inoperable pancreatic cancer. This study will evaluate the efficacy of the Cell-in-a-Box technology combined with ifosfamide to delay malignant ascites production. The research, overseen by Dr. Matthias Löhr, aims to replicate promising results from previous studies. Currently, no approved therapies exist for delaying malignant ascites, highlighting the potential impact of PharmaCyte's innovative approach.

PharmaCyte Biotech (NASDAQ: PMCB) announced that the capsule material of its CypCaps pancreatic cancer product does not cause skin irritation, supporting its Investigational New Drug (IND) application to the FDA. CEO Kenneth L. Waggoner noted that this data reaffirms the safety of CypCaps, moving them closer to a clinical trial for locally advanced, inoperable pancreatic cancer. A third-party study showed no toxicity or skin reactions in New Zealand white rabbits after intracutaneous injection of the capsule extract. PharmaCyte focuses on cellular therapies for cancer and diabetes using its Cell-in-a-Box technology.