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[$Pistol Pete$]

$PMCB Pharmacyte Biotech Inc (OTCMKTS:PMCB) Has A Fast Track To Commercialization PMCB



Things are really starting to pick up pace at Pharmacyte Biotech Inc (OTCMKTS:PMCB). A look at the company’s share price doesn’t suggest as much, but operational developments do, and when markets shift to reflect what’s going on behind the scenes, the stock should run.

The longer this shift takes, the larger the disparity between PPS and fundamental development, and – by proxy – the larger the run.

What makes us think there’s a disparity?

Well, regular readers will likely be familiar with this company – it’s one we’ve ended up coming back to on a number of occasions. The company is a development stage biotechnology entity with a lead focus on oncology (for now, that is), and specifically, a focus on a therapy it coins Cell in a Box. It’s essentially a targeted cancer treatment, that uses an encapsulation to deliver a toxic compound direct to the region in which cancer cells reside. The treatment is then activated post-delivery, and because it’s already at the site where it’s required, it has little impact on healthy systemic cells, meaning it has a comparatively low (far lower, in fact) toxicity to these healthy cells than standard of care systemically administered chemotherapy agents.



As we noted late January, the cancer that Pharmacyte has in its scope right now is pancreatic cancer, the deadliest cancer in the US and one that is crying out for a new treatment to become available. A trial that pitches its asset against current standard of care chemo agents is set to begin near term, and it has the potential to be a game changer for PharmaCyte.

Why?

A couple of reasons, but primarily, the potential for it to allow the company to cut out around 90% of the time and cost normally associated with bringing a drug like this to market. Pharmacyte completed a pre IND meeting with the FDA earlier this year, and is currently putting together a protocol for the above mentioned study. The company has a very reputable and established CRO called TD2 on board, as detailed in this interview with said CRO’s CEO, and has trademarked the specific version of the Cell in a Box technology to be used in the trial as CypCap. A new Senior Strategic Advisor just came on board, a Dr. Leonard Makowka, and is putting together an IND as we speak. And here’s the important part. With all these elements in place, and if the IND that the company submits contains protocol that covers a few key points, then the exploratory trial that Pharmacyte is about to undertake could qualify as a pivotal study (read: a study that could underpin an NDA) on completion.

The criterias indicated by the FDA that the company needs the trial to fulfill are the drug showing promise, a high enough patient count, and primary endpoints of overall survival (OS) and safety rather than progression free survival (PFS) and safety. For us, that’s a simple enough task. Sure, the drug has to end up working, but look at it this way – if the drug didn’t work, the company would likely end up carrying it through a phase I safety study and into a phase II study, only to waste something like $15 million on the first and $40 million on the latter, before finding out it doesn’t work anyway. If the drug does work, with the above discussed pathway, it gets to market quickly and cheaply. If it doesn’t work, Pharmacyte hasn’t wasted $50 million or more finding that out.

Win win.

So what’s next?

It’s all about getting the IND past the FDA now. From the tone in the interview we linked to above (with TD2’s Stephen Gateley) it looks as though the ducks are in a line for a quick trial start once the FDA gives the protocol a green light.

Like we said last time, 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 early holders. If the drug performs, however, this dilution will be a footnote to the gains we see at trial completion.