$PMCB Valuing PharmaCyte Biotech's New Treatment Option for Pancreatic Cancer
BALTIMORE, MD / ACCESSWIRE / March 9, 2016 / The current gold standard of care for patients with advanced, inoperable pancreatic cancer is the combination therapy of Abraxane® + gemcitabine, which was approved by the U.S. Food and Drug Administration (FDA) in late 2013. Another treatment, which is not used as widely, is FOLFIRINOX, a four-drug combination therapy. These treatments offer varying degrees of efficacy but what happens to the patients when they no longer respond to these therapies? With limited options currently available, PharmaCyte Biotech (PMCB) is set to launch a new, mid-stage clinical trial in 2016 to specifically address what is clearly an unmet medical need and potentially increase the lifespan prospects for these late stage pancreatic cancer sufferers.
Positive results from this landmark trial would move PharmaCyte toward the front of the pack of cancer treatment providers, substantially enhance the value of the Company and attract the attention of major pharmaceutical companies. After all, a successful trial could be the trigger to change the way advanced inoperable pancreatic cancer is treated. It would finally give patients, who no longer respond to the premier combination therapy, a viable option. PharmaCyte's pancreatic cancer treatment (Cell-in-a-Box®+ low-dose ifosfamide chemotherapy) seeks to satisfy this critical unmet medical need by acting as a consolidation (and post- Abraxane® + gemcitabine or FOLFIRINOX) therapy.
Huge Addressable Market
A recent report issued by Research and Markets suggests that the size of the pancreatic cancer therapeutic markets in just the major developed countries will approach $3 billion in the next 5 years. However, the near term addressable market for PharmaCyte's therapy in the U.S. alone is substantial. A typical current price tag for pancreatic cancer therapy for the roughly 43,000 patients diagnosed with the disease each year ranges anywhere from $50,000 - $75,000. More than 60% of this patient group, or roughly 25,000 patients, will no longer respond to the premier combination therapy (Abraxane® + gemcitabine or FOLFIRINOX) and require a new, or consolidation therapy. Therefore, should PharmaCyte ultimately receive FDA approval for its treatment, the Company's initial target market size would range from $1.25 billion to $1.8 billion, depending upon pricing for the Company's therapy. Clearly, there is tremendous underlying value in PharmaCyte and its novel therapy.
The Trial
PharmaCyte has designed a Phase 2b clinical trial that will include a hard-stop at 6 months to evaluate the data. The primary endpoints of the trial will essentially mirror some of the primary endpoints of other treatments that have received FDA approval, such as Abraxane®. These include progression-free survival (PFS) and the side effects experienced from the combination treatment that occurs in the patients. PFS is the time that elapses from the first day of treatment until the disease gets worse and will be measured and determined at 6 and 12 months. The occurrence of any side effects will be monitored throughout the trial.
The trial design also includes a series of measurable secondary endpoints. These include:
- Onset of pain and need for pain medications
- Whether inoperable tumors become operable as a result of treatment;
- Change in tumor size; and
- Patient overall quality of life during the treatment.
The Company's consolidation therapy approach is poised to emerge as a win-win for the Company and patients alike. This positioning, along with an innovative trial design, enable PharmaCyte to launch and complete this clinical trial at a substantially reduced cost and shorter time period relative to typical studies since it will be conducted with fewer patients and in key sites in the U.S. and abroad. In addition, by measuring pain as one of the secondary endpoints, the Company eliminates the need to launch costly separate trials or studies to track the unbearable and untreatable pain that is associated with pancreatic cancer in 20-25% of patients. Finally, because the design of the trial allows for the release of interim data relatively quickly, it only enhances the value of the therapy to the Company and prospective patients.
Impact of Potential Approval
Positioning its innovative treatment as the next or last stage therapy for the difficult patient treatment group may be the fastest route to PharmaCyte's FDA approval, as there is no truly effective therapy for patients at this stage that can materially extend survival rates and improve their quality of life. Measurements will also be taken to determine if PharmaCyte's treatment can convert an inoperable tumor to an operable one. If tumor shrinkage data proves encouraging, it could have a materially favorable impact on a trial's outcome, let alone the quality of life and lifespan of pancreatic cancer patients, and the overall valuation of the Company among cancer treatment leaders.
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Goldman Small Cap Research Rob Goldman, Analyst 410-609-7100 rob@goldmanresearch.com
Mr. Caprino served as President & Co- Founder of Secure Info Imaging a manufacturer of hand-held data capturing devices. Prior to Secure-Info Imaging, served as President and Founder of Easyfeed.com. Easyfeed.com was a Southern California full service ASP, offering, E-commerce Solutions, Web Hosting, Specialized Business Software solutions, Wireless Internet & high speed Telco Internet Solutions for the commercial banking industry. From 1985 through 1990 Mr. Caprino was President and Chief Executive Officer for Data Tech Memories, a high capacity Winchester Disc Drive manufacturer utilizing a unique design that Mr. Caprino was instrumental in developing. In 1981 Mr. Caprino led the team, which was awarded the largest OEM contract for Entry Level Computers from International Business Machines (IBM) in Boca Raton Florida, a $120 Million Contract. Mr. Caprino built factories in both Boca Raton, Florida and Singapore.
Mr. Caprino received his Electronic Science Degree from Don Martin School of Radio Science. ROY GIVENS | Co-Founder & Chief Technical Officer
Mr. Givens served as CEO and President of Pantrol Controls in Spokane, Washington. Mr. Givens Roy successfully led Pantrol Controls from $250,000 to over $15 million in annual sales and 60 employees. Pantrol was Washington State’s top 10 minority owned businesses and was voted Washington State’s fastest growing small business. Mr. Givens has developed many new products including pellet stove control boards, custom control panels and service entrance panels for cell phone towers.
Mr. Givens received his Technical Degree at Spokane Community College and received his Business Degree from Boise State.
GREG CERVANTES | Director of Business Development & Government Affairs
Cervantes collectively has served over 25 years in Government Affairs and Business Development. The former Mayor for the city of Coachella, he served as a Deputy Director for the United States Congress under the leadership of United States Representative and former United States Ambassador, Esteban E. Torres. He later served as Executive Director of Government Affairs for the Cabazon Band of Mission Indians and District Director for the 56th Assembly District and Majority Leader for the California State Assembly, V. Manuel Perez. Cervantes currently serves as Special Advisor to President Tony Sanchez, Jr. of the Seminole Tribe of Florida, Inc. Cervantes also serves alongside the former Secretary of the Interior, Ken Salazar, as a Government Affairs Consultant to Wilmer Hale, Law Firm.
Cervantes earned his Graduate Degree from Georgetown University and his Undergraduate Degree at the University of California Riverside.
ROBERT FOSTER | Advisory Board Director
Foster served as mayor of Long Beach, Calif., from 2006 to 2014. He worked at Southern California Edison from 1984 to 2006, most recently as president of the utility, where he led California’s largest electric company through the 1999 energy crisis. During his tenure, SCE developed the biggest renewable, clean energy programs in the United States in solar, geothermal, biomass and wind. Before that, Foster was deputy executive director of the California Energy Commission, helping establish statewide energy efficiency standards, many of which are still in place today. Foster was appointed as the Environmental Committee Chair in 2008, elected to the Advisory Board in 2009 and elected to the Board of Trustees in 2010 for the U.S. Conference of Mayors. Foster was appointed by Gov. Arnold Schwarzenegger to the Board of Governors for CAISO in 2010 and was reappointed by Gov. Edmund G. Brown Jr. to a second three-year term in January 2013. Foster is a graduate of San Jose State University with a degree in public administration.
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