Welcome to PharmaCyte BioTech
An OTCQB Company
FDA Grants Orphan Drug Designation to Pharmacyte Biotech for Pancreatic Cancer Treatment
European Medicines Agency (EMA), the European Commission has granted the Orphan Drug designation to PharmaCyte’s subsidiary,
PharmaCyte Biotech Europe Limited, for PharmaCyte’s pancreatic cancer treatment
DR. DANIEL VON HOFF is TD2’s Chief Development Officer
Pharmacyte Biotech Key Members
Encapsulated Cells Expressing a Chemotherapeutic Activating Enzyme Allow the Targeting of Subtoxic Chemotherapy and Are Safe and Efficacious:
Data from Two Clinical Trials in Pancreatic Cancer
PharmaCyte Biotech, Inc.
23046 Avenida de la Carlota, Suite 600
Laguna Hills, California 92652
Office Number: 917.595.2850
Facsimile Number: 917.595.2851
Email: [email protected]
$122,386,272 a/o Dec 19, 2016
848,904,665 a/o Aug 29, 2016
1,490,000,000 a/o Aug 26, 2014
817,204,665 a/o Aug 29, 2016
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What is Cell-in-a-Box®?
The Cell-in-a-Box® technology, developed by Austrianova, is a means to protect, isolate, storeand transport living cells. The proprietary technology can be used for a variety of purposes.
In healthcare, it facilitates the safe implantation of cells, holding them isolated from the immune system and allowing long term production of therapeutic molecules in patients.
In biotechnology, the Cell-in-a-Box® technology protects cells in bioreactors and fermenters, while at the same time simplifying purification of bioproducts produced from the cells and reducing production cost.
The technology can also be applied to probiotics, cosmetics and agriculture, environmental protection and monitoring, as well as forming the basis of a powerful research tool.
The company’s proprietary cell packaging material, Gel8, used for the Cell-in-a-Box® technology, is derived from a naturally occurring material and is thus harmless to the environment, biologically inert and has been shown to be safe in humans.
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. PharmaCyte Biotech's treatment for pancreatic cancer involves low doses of the well-known anticancer prodrug ifosfamide, together with encapsulated live cells, which convert ifosfamide into its active or "cancer-killing" form. These capsules are placed as close to the cancerous tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. This "targeted chemotherapy" has proven remarkably effective in past clinical trials. In addition, PharmaCyte Biotech is working towards improving the quality of life for patients with advanced pancreatic cancer and on treatments for other types of solid cancerous tumors.
SMMG Radio Interview with COO Dr. Crabtree ~ 2013
Shareholder Update with CEO & COO via SMMG Interview ~ July 2014
The proprietary technology can be used for a variety of purposes.
In healthcare, it facilitates the safe implantation of cells, holding them isolated from the immune system and allowing long term production of therapeutic molecules in patients.
In biotechnology, the Cell-in-a-Box™ technology protects cells in bioreactors and fermenters, while at the same time simplifying purification of bioproducts produced from the cells and reducing production cost.
The technology can also be applied to probiotics, cosmetics and agriculture, environmental protection and monitoring, as well as forming the basis of a powerful research tool
Kenneth L. Waggoner, Chief Executive Officer and President:
Further highlights of Mr. Waggoner’s career include leadership and legal positions with several start-up companies during the last several years as well as working with Fortune 500 companies most of his professional career. During his tenure with Chevron, Mr. Waggoner served as the Vice President and General Counsel of its Global Downstream operations where he was responsible for the overall management of legal services to the North American, Latin American, Europe and Asian Products Companies. At Chevron he led a successful restructuring of the company’s international Legal Department following Chevron’s acquisition of Texaco.Kenneth L. Waggoner has almost four decades of experience in management, business, operations and law. Mr. Waggoner started his career as an attorney in private practice. Notably he was a senior partner with Brobeck, Phleger and Harrison, named one of the top two law firms worldwide that provide services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech and many others. He was the Managing Partner of Brobeck’s Los Angeles office. Mr. Waggoner was also a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. While at Brobeck, Mr. Waggoner was the Co-Chairman of Brobeck’s world-wide Environmental Law Group.
Mr. Waggoner received his Juris Doctorate. with honors in 1973 from Loyola University School of Law in Los Angeles.
Gerald W. Crabtree, Ph.D. – Chief Operating Officer and Director:
Dr. Crabtree is the Company’s Chief Operating Officer. Since 1985, Dr. Crabtree has been involved with various biopharmaceutical companies where he has alternatively supervised and coordinated the development of multiple drug candidates, prepared clinical protocols, investigator brochures, monographs, research and review articles and served as project manager for development of major oncologic agents. He is a Member of the American Society of Clinical Oncology and also is a past member of research grant review committees for the National Institute of Health and the American Cancer Society. Dr. Crabtree established and directed, from inception, a department that monitored and coordinated the development of oncologic and immunologic drugs from initial discovery through regulatory approval in a major pharmaceutical company and served as project manager for the development of the anticancer agent, Taxol®.
Dr. Crabtree received his Ph.D. in Biochemistry from the University of Alberta, Edmonton, Alberta, Canada and has published over 80 articles in peer-reviewed journals. He is a National Cancer Institute of Canada Research Fellow. In addition, he served as Department Head of Molecular Pharmacology for the Nucleic Acid Research Institute, and prior to that as Associate Professor of Medicine with the Roger Williams Cancer Center at Brown University. Dr. Crabtree has also served as Director of Project Planning and Management (Oncology/Immunology) at Bristol-Myers Squibb and as Vice-President of Research and Development at ETEX Corporation. Most recently, Dr. Crabtree served as Interim CEO of PhytoCeutica, Inc., where he assisted in preparation and review of FDA documents, clinical study protocols, investment acquisitions and contracts and business plans.
Walter H. Gunzburg – Chief Scientific Officer: Dr. Matthias Lohr as Chairman of Scientific Advisory Board: Matthias Löhr was appointed professor of gastroenterology & hepatology at Karolinska Institutet in 2007, incoming from the Univ. Heidelberg/dkfz. From the times of his MD thesis through PhD and lateron, he concentrated on several aspects of the pancreas, both in clinical medicine, translational and basic sciences. He is heading the Pancreas Research Team at Gastrocentrum and leading the KICancer Diagnose-related network for HPB tumors. For hte European Gastroenterologists (UEG), he is sitting in several committees at the EU in Brussels. He is also leading the Pancreas 2000 program, an educational program for future pancreatologists in Europe.
Prof. Walter H. Gunzburg is the co-founder, Chairman of the Board and Chief Technical Officer of Austrianova. As well as being a full Professor of Virology at the University of Vienna since 1996, he has had many years of experience in the biotech industry. He was a scientific advisor to the international vaccine company, Bavarian Nordic, from 1994-2001 and was involved in their IPO. He has also been an scientific advisor to the German biotech companies, Paktis and Liponova, as well as the U.S. biotech company, Tocagen Inc., all of which developed/are developing advanced medicinal treatments for cancer. He was also the Director of the Christian Doppler Laboratory for Gene Therapeutic Vector Development from 2003-2011. Currently, he is a board member of ViruSure, a virus and prion testing company located in Vienna that he cofounded.
Prof. Gunzburg has been actively involved in European ethics and regulatory affairs in the fields of cell and gene therapy as well as xenotransplantation for many years. He was a member of the German Medical Association's Central Commission for Somatic Gene Therapy. He has also interacted with a number of regulatory agencies including the US FDA, EMA, TGA, HSA and Thai-FDA and was on the review panel for the Paul Ehrlich Institute, Langen, Germany. Prof. Gunzburg continues to be an active researcher and has published more than 130 peer-reviewed publications in international scientific and medical journals such as Nature, The Lancet,Proceedings of the National Academy of Sciences USA and Cancer Research as well as co-authoring the first German language textbook on gene therapy. He is also a member of the editorial board of a number of international cell and gene therapy journals including Trends in Molecular Medicine, and continues to be an active reviewer for many top tier journals as well as grant funding agencies.
Thomas Liquard - Chairman of the Audit Committe
Thomas Liquard was appointed to the Board on April 27, 2015. Mr. Liquard has more than a decade of experience in the pharmaceutical industry, having held various commercialization, product development and leadership roles with big pharma and biotech companies. From 2013 to 2014, Mr. Liquard was COO then CEO of Alchemia Limited (Alchemia), a major Australian biotech company (ASX: ACL) with an FDA-approved sterile injectable and a late stage oncology platform. During that time, Mr. Liquard administered an AU$ 25 million budget and Alchemia had revenues of AU$ 15 million. While at Alchemia, Mr. Liquard rebuilt that company’s valuation which had lost 23% after the departure of the prior CEO, brought two major investors into the register, improved its stock price to a 52-week high and led all business development and corporate development activities.
Prior to joining Alchemia, Mr. Liquard spent seven years with Pfizer, Inc. (Pfizer) in New York, where he held various commercial roles of increasing scope and responsibility, including most recently as Senior Director, Portfolio Development Leader and Emerging Markets for the Established Products portfolio. In that role, Mr. Liquard drove business development (M&A, licensing, partnerships) and internal product development initiatives and managed more than 70 opportunities at various stages of execution. During his tenure at Pfizer, Mr. Liquard also spent three years as a key member of the company’s Established Products US Brands P&L Leadership Team where he engineered the group’s 505(b)(2) investment strategy, culminating in the $700M acquisition of NextWave Pharmaceuticals, Inc. (NextWave). He also led the NextWave pre- and post- acquisition integration efforts. In addition, Mr. Liquard worked as a Director within the New Product Planning and Portfolio & Decision Analysis groups at Pfizer from 2007 to 2010. There he was responsible for formulating investment decisions on business development opportunities and internal development programs across multiple therapeutic areas including oncology and metabolic diseases, including diabetes and central nervous system.
From 2004 to 2007, Mr. Liquard served as Senior Consultant to the Frankel Group, where he specialized in the life sciences. While at the Frankel Group, Mr. Liquard was lead consultant for global “war-gaming” in support of a $3.0 billion supportive care biologic, facilitated multiple competitive planning sessions in the United States, Europe and Canada and performed due diligence analyses on multiple potential in-licensing targets. Mr. Liquard holds an MBA from Columbia Business School and a Bachelor of Science degree from the University of Southern California.
Dr. Eva Maria (Lilli) Brandtner – Director of Diabetes Program Development
Following receipt of her Doctorate in Natural Sciences in the areas of Biochemical Microbiology and Molecular Genetics in 2001, Dr. Brandtner served as a Postdoctoral Scientist and Senior Postdoctoral Fellow at Austrianova Biomanufacturing AG in Austria where she was involved in the development of retroviral vectors for gene therapy. In 2007, Dr. Brandtner moved to Singapore and became Project Manager for work on the cell-based therapy of liver cancer at the same company. Shortly thereafter, Dr. Brandtner was promoted to Senior Scientist at Austrianova Pte Ltd (Austrianova) where she oversaw the development of numerous projects concerned with live cell Bioencapsulation. This was followed in 2010 by her promotion to Chief Scientist at Austrianova, responsible for all encapsulation projects in medicine and biology. Most importantly, while at Austrianova, Dr. Brandtner was intimately involved in all of the preclinical work done there that included the use of live cell encapsulation in developing a treatment for insulin-dependent diabetes. Due to family commitments, in 2012 Dr. Brandtner left Singapore to return to Austria where she is currently employed as Head of the Bioencapsulation Unit at the Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT).
Dr. Brandtner is co-inventor on two granted patents and is named on several additional patents that are in preparation. She has co-authored numerous research reports that have been published in reputable scientific journals and has presented research results at national and international scientific conferences and meetings. Dr. Brandtner is a member of the European Association for the Study of Diabetes (EASD), the Austrian Diabetes Association (ÖDG) and the European Society for Gene and Cell Therapy (ESGCT).
Dr. Manuel Hidalgo, Scientific Advisory Board:
In his role at the prestigious Beth Israel Deaconess Medical Center (BIDMC), Dr. Manuel Hidalgo oversees all BIDMC’s clinical cancer programs. Dr. Hidalgo’s groundbreaking work in experimental cancer therapy and tumor model development has led to key advances in the treatment of pancreatic cancer.
The BIDMC’s Cancer Center consists of multiple disciplines including medical oncology, surgical oncology, radiation oncology, radiology and pathology. Twenty-one specialty patient-care programs focus on, among others, pancreatic cancer, breast cancer, prostate cancer and biologic therapy. The Cancer Center, with 160 faculty members and more than $70 million in annual research support, is also home to the Cancer Clinical Trials Office, where hundreds of clinical trials provide patients with access to promising new therapies.
BIDMC is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and The Jackson Laboratory.
Dr. Hidalgo formerly served as the Director of the Clinical Research Program and Vice Director of Translational Research at the Spanish National Cancer Center. From 2011 to 2009, Dr. Hidalgo was Co-Director of both the program for Drug Development and Gastrointestinal Oncology at John Hopkins university in Baltimore, Maryland.
Dr. Hidalgo received his M.D. degree from the University of Navarra in Pamplona and his Ph.D. degree from the University of Autonoma in Madrid, Spain. Dr. Hidalgo completed his training in drug development at the University of Texas Health Science Center in San Antonio, Texas, where he worked closely with Dr. Daniel D. Von Hoff as an Assistant Professor of Medicine.
Dr. Hidalgo currently holds faculty positions at University CEU San Pablo and Johns Hopkins University.
Dr. Hidalgo has been an invited participate or speaker at almost 200 meetings or symposia and co-authored more than 175 scientific articles, 47 review articles, 9 editorials, commentaries and letters to the editors of scientific publications and 8 book chapters. He is currently a reviewer or editor for several major scientific publications and has been or is a member of several international cancer-related organizations. Dr. Hidalgo has received funding from major scientific organizations that include the National Institute of Health, the National Cancer Institute, the American Society of Clinical oncology (ASCO) and the American Association for Cancer Research (AARC). Dr. Hidalgo was the recipient of a Clinical Research Fellowship from the AACR and a Career Development Award from ASCO for his work on epidermal growth inhibitors such as Tarceva®.
Dr Hidalgo’s primary focus now is on the development of novel therapies for pancreatic cancer.
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