Pharmacyte Biotech Inc Stock Price, News & Analysis

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.

PharmaCyte Biotech (NASDAQ: PMCB) announced positive results from a third test of its CypCaps product for pancreatic cancer, confirming that the capsule material is non-mutagenic. This aligns with their ongoing commitment to meet FDA data requirements and supports the safety of their product. The third-party study adheres to OECD standards and emphasizes the device's safety profile. The company continues to develop therapies for cancer and diabetes using their Cell-in-a-Box technology, positioning itself for future advancements in treatment.

PharmaCyte Biotech (NASDAQ: PMCB) announced positive results from its second FDA-required biocompatibility test of the CypCaps™ product, revealing that the capsule material is non-hemolytic. This test confirms earlier findings that the biocompatibility of the capsule does not cause blood cell destruction. Conducted by a third-party organization, the results align with PharmaCyte’s goal of developing cellular therapies for pancreatic cancer and diabetes using its Cell-in-a-Box® technology, enhancing prospects for clinical advancement.

PharmaCyte Biotech (NASDAQ: PMCB) announced the initial results of biocompatibility studies for its CypCaps product, a component in its pancreatic cancer treatment. The study confirmed that the cellulose sulphate capsules do not activate the complement system, a key part of the human immune response, ensuring safety for patients. Conducted by a third-party GLP lab, this study is part of ongoing research to evaluate the CypCaps' effectiveness and compatibility. Further results from additional studies are expected in the coming weeks.

PharmaCyte Biotech (NASDAQ: PMCB) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference, taking place virtually from September 13-15, 2021. CEO Kenneth L. Waggoner will present and engage in meetings with institutional investors. He emphasized the company's milestone of having sufficient capital for ongoing development of its cancer and diabetes cellular therapies, which utilize the proprietary Cell-in-a-Box® technology. The presentation will be available on-demand from September 13, 2021, at 7:00 a.m. EDT.

PharmaCyte Biotech (NASDAQ: PMCB) announced that its clinical trial product, CypCaps™, remains stable and active 18 months post-storage at -80ºC, affirming a minimum shelf life of 18 months. This positive stability data will contribute to PharmaCyte's updated submission to the FDA aimed at lifting the clinical hold on its Investigational New Drug application (IND) for the treatment of inoperable pancreatic cancer. The ongoing study confirms product integrity and viability, supporting the company’s goal to advance to a Phase 2b clinical trial.

PharmaCyte Biotech (NASDAQ: PMCB) has announced an expansion of its product pipeline to include diabetes and malignant ascites programs, following the successful closing of two public offerings that raised approximately $90 million. CEO Kenneth L. Waggoner emphasized that this funding enables the company to lift the clinical hold imposed by the FDA and proceed with a clinical trial for locally advanced, inoperable pancreatic cancer (LAPC). The additional capital allows PharmaCyte to broaden its development efforts, having previously focused solely on LAPC.