Shares of PharmaCyte Biotech are climbing back up the charts after being on a downtrend for the past year. The stock hit highs of $.069 last December and drifted all the way down to $.01 a share over the summer.
Now, PharamaCyte Biotech looks to have bottomed as the tiny biotech continues to engage with the US FDA. In this article, we take a look at the bull case for PharmaCyte Biotech and why current levels present an attractive investment opportunity, especially when you consider the potential upcoming catalysts.
First up, here’s a little background info for those not familiar with the company. PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor.
Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment-related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of the cell lines will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
Investigational New Drug Application (IND)
On September 2nd, PharmaCyte Biotech submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
Once PharmaCyte (the sponsor) submitted its IND, the sponsor must wait 30 calendar days before initiating any clinical trial. During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the interactions with the FDA:
“We anticipated a number of engagements with the FDA to supplement key information related to our complex treatment. We are advancing a biologic, which is far more complex than developing a single-molecule drug. To our knowledge, the FDA has never had to assess a live-cell encapsulation technology such as ours. The FDA is fully engaged as it assesses the need for our product candidate to be safe and to comply with every cGMP regulation and FDA guidance. So far, we have had 5 opportunities to answer the FDA’s questions by supplying the regulatory agency with further clarification and supporting documentation, and we’re pleased with the process to date.”
Phase 2b clinical trial
The proposed multicenter, randomized, open-label Phase 2b clinical trial is intended to evaluate the efficacy and safety of CypCaps (genetically engineered human cells encapsulated using the Cell-in-a-Box technology) in combination with low doses of the chemotherapy prodrug, ifosfamide, as compared to chemoradiation therapy with capecitabine plus external beam radiation therapy (“EBRT”) or stereotactic body radiation therapy (“SBRT”) alone.
The study population will consist of approximately 100 patients. Patients will be randomized in a 1:1 ratio to either treatment with the study therapy or a comparator. The randomization will be stratified by previous treatment (Abraxane plus gemcitabine or FOLFIRINOX) and the control arm choice (capecitabine/EBRT or SBRT alone).
The primary objective will be determined by progression-free survival (“PFS”). The secondary objectives for this study are to determine if CypCaps plus low-dose ifosfamide will: (i) increase overall survival (“OS”); (ii) increase objective response rate; (iii) increase the rate of conversion of the pancreatic tumor from inoperable to operable; (iv) decrease the pancreatic cancer tumor marker CA 19-9; and (v) improve a patient’s quality of life. In addition, this clinical trial will assess the safety and tolerability of CypCaps plus low dose ifosfamide.
PharmaCyte Biotech Bottom Line
It’s all about getting the IND past the FDA now. From the tone in the recent press releases, it looks as though the ducks are in a line for a quick trial start once the FDA gives the protocol a green light.
However, it’s not all roses. We’re probably going to see a raise near term (cash is basically non-existent) and this is going to dilute shareholders. If the drug performs, however, this dilution will be a footnote to the gains we see at trial completion.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:PMCB or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.