Faster Route To Approval and Reduced Clinical Trial Length Ahead for PharmaCyte
BALTIMORE, MD / ACCESSWIRE / November 30, 2015 / Goldman Small Cap Research, a stock market research firm specializing in the small cap and microcap sectors, announced today that it has published a new sponsored research article on PharmaCyte Biotech, Inc. (OTCQB – PMCB), a publicly traded, clinical stage biotechnology company focused on developing and preparing treatments for cancer and diabetes. To view the sponsored research article, along with disclosures and disclaimers, or to download it and previous reports, updates, and articles in their entirety, please visit www.GoldmanResearch.com.
In the article, analyst Rob Goldman notes that recent and pending events infer that the road to approval and marketing of its flagship pancreatic cancer treatment (Cell-in-a-Box(R) + low-dose ifosfamide chemotherapy), has been dramatically shortened, potentially leading to a banner year 2016 for PharmaCyte shareholders.
Goldman reported, “Earlier this month, PharmaCyte announced that upon the recommendation of the 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. This award follows a similar designation awarded by the FDA in 2014.”
Goldman further noted, “While granting Orphan Drug designation is no guarantee of approval for the providers, it appears that the odds are increased for these assignees’ offerings versus non-Orphan Drug designation treatments. In fact, the FDA Office of Orphan Products Development (OOPD) program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983.”
“Separately, management recently updated investors on its proposed Phase II clinical trial design roadmap. The design includes the selection of progression-free survival as the primary endpoint which should lead to a shorter than anticipated trial length plus an approach that positions the Company’s therapy with the fastest route to approval. Rather than used as a front-line therapy, the PharmaCyte treatment shall be positioned as an expansion of the current gold standard of care or as a consolidation therapy. Targeting the next or last stage therapy for the difficult patient treatment group may be the fastest route to 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,” continued Goldman.
According to Goldman, “Investors can expect a busy year of milestones for PharmaCyte in 2016 just for the pancreatic cancer trial alone. These include the approval of its GMP facility in Asia for both manufacture and processing — from which the Company will source live cells for its trial, and a pre-IND (Investigational New Drug) meeting with the FDA, ahead of the official IND filing. Once given the go-ahead by the FDA, the trial launch should commence during the second quarter with preliminary results released sometime in 2017. With major events on the near term horizon, it is not likely that this sub-$100 million mid-stage biotech will stay under the radar for long.”
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, daily stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.
This press release contains excerpts of our most recently published sponsored research report 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.
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About PharmaCyte Biotech:
PharmaCyte Biotech Inc. (OTCQB – PMCB) 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(R). 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. More information on PMCB can be found at www.PharmaCyteBiotech.com.
Contact:
Goldman Small Cap Research
Rob Goldman, Analyst
410-609-7100
rob@goldmanresearch.com
SOURCE: Goldman Small Cap Research
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