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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.
About Goldman Small Cap Research: Founded in 2009 by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and microcap stock research reports, articles, stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.
This press release reflects our most recently published sponsored research article on PharmaCyte Biotech, Inc. The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research relied solely upon information derived from PharmaCyte Biotech Inc. (“the Company”) authorized press releases or legal disclosures made in its filings with the U.S. Securities and Exchange Commission http://www.sec.gov.
Separate from the factual content of our articles about the Company, we may from time to time include our own opinions about the Company, its business, markets and opportunities. Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.
A Goldman Small Cap Research report, update, newsletter, or article is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed is to be used for informational purposes only. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other agency. To download our research, view our disclosures, or for more information, visit www.goldmanresearch.com. In 2015, Goldman Small Cap Research was compensated by a third party (not PharmaCyte or anyone affiliated with PharmaCyte) in the amount of $22,000 for investment research services that includes the publication of research reports, updates, and a series of articles.
Goldman Small Cap Research
Rob Goldman, Analyst
410-609-7100
rob@goldmanresearch.com
SOURCE: Goldman Small Cap Research