Clinical Milestones Abound for PharmaCyte Biotech in 2015
Late last week, PharmaCyte Biotech, Inc. (OTCQB – PMCB - $0.138 – Spec Buy) announced that it was on track to commence clinical trials in the second half of 2015, milestone events that many investors believe will take the Company’s profile and valuation to a new level. After all, it is no secret that biotech investors tend to gravitate to companies on the cusp of trial initiations. The reasoning behind these moves is simple. The initiation of any trial, preclinical or late stage, can be a harbinger of potential product development success, depending upon the trial’s outcome. At the least, the commencement of a trial is an affirmation that a biotech company’s technology or approach has merit and may be deserving of future material consideration by peers and investors alike.
With three separate clinical trials for the treatment of advanced pancreatic cancer and the symptoms associated with it as well slated to begin in a matter of months, PharmaCyte Biotech’s moves are bound to generate a great deal of attention, since it is so rare that a small biotech would launch three separate clinical trials in such short order.
The most highly anticipated event is a Phase 2b trial in Australia where PharmaCyte Biotech's pancreatic cancer treatment will be compared "head-to-head" with the best available chemotherapy (Abraxane(R) plus gemcitabine) for advanced pancreatic cancer, using its Cell-in-a-Box(R) live cell encapsulation technology, and placing the capsules with the live cells inside them near the site of the cancerous tumor. The patient will be given an inactive cancer drug, ifosfamide, intravenously at one-third the normal dose. When the blood carrying the ifosfamide comes in contact with the encapsulated cells the ifosfamide is converted into its cancer-killing form.
Two additional clinical trials will be conducted in the U.S. by Translational Drug Development (TD2). These trials will determine the effectiveness of PharmaCyte Biotech's treatment in reducing the severe pain that occurs in patients with advanced pancreatic cancer and slowing the accumulation of malignant fluid (ascites) that accompanies the development of pancreatic and other solid cancerous tumors in the abdomen.
Although not seemingly as high profile as the Phase 2b trial, these two trials are landmark events in their own right. These preclinical trials for abdominal cancers using the Company’s platform technology were designed, in part, by the leading authority on pancreatic cancer, Dr. Daniel Von Hoff, and conducted by America’s leading Contract Research Organization that specializes in preclinical and early-mid phase clinical trials in oncology. Having such distinguished authorities associated with these trials affirms the potential value and efficacy of the Company’s technology and could result in future, fast-tracked clinical trials.
In an era when small biotech companies may only launch one trial a year, having three, high profile, abdominal cancer trial events to look forward to this year could put PharmaCyte Biotech on the map.
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Senior Analyst: Robert Goldman
Rob Goldman founded Goldman Small Cap Research in 2009 and has over 20 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray's Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.'s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.
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