Briacell Therapeutics Corp T.BCT

RE:RE:Today's Release (good summary Vacc)

[WatchLearnEarn]

Oh, imagine that, the 1-Star Brigade is marching! D!CK!

WatchLearnEarn wrote: I've been in and out of many pharma stocks over the past 5 years and when I say "in and out" I mean "mostly in and waiting, waiting, waiting." That's the nature of this industry. Trials take forever and then whenever FDA or HC get involved it's like time literally stands still while they do whatever it is they're doing.

Timelines are always stated in the most optimistic, if-all-goes-exactly-as-planned terms, and it's a common scenario for companies to experience delays in reporting clinical results within the timeframes stated in news releases months before that point comes. So, even though the company say they're "on track to announce data on the first 10 patients in the first quarter of 2018" that could easily (and probably will) get pushed out to Q2.

So, we wait and watch the SP trend downward unless they have something positive to say in the meantime (JV? Patent? Innovative discovery? etc.) Of course any negative developments (PP? Share consolidation? Adverse trial event? etc.)  will hasten the SP decline.

Of course, I'm hoping for additional positive developments while we wait, but planning for negative, probably in the form of an imminent PP. The CEO PP in February 2017 brought in $1.3M. The prior PP in August 2016 brought in $1.7M and the previous one (well, two back to back) in April 2016 brought in $1.25M ($600k PP and $650k subscription by biotech fund.) That's 4 months and then 6 months in between financing events, but nothing now since Feb 2017 (10 months) and they're burning through cash like a California wildfire with the Briavax trial and BriaDX development. So, I'm expecting a PP announcement, like yesterday. It sucks to have to do a dilutive financing at such low SP levels but they need cash and hopefully the next one they do (after positive initial trial results) will be at a much higher valuation.

Don't even get me started on the reverse split that will undoubtedly accompany their intended uplisting to NASDAQ. 

tooez1 wrote:

Very Clearly presented announcement, directly stated......
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Press release from GlobeNewswire (a Nasdaq OMX company)

BriaCell Provides Clinical Update on its Lead Vaccine Candidate, BriaVax™

Monday, November 06, 2017
 

BriaCell Provides Clinical Update on its Lead Vaccine Candidate, BriaVax™

08:30 EST Monday, November 06, 2017

BERKELEY, Calif. and VANCOUVER, British Columbia, Nov. 06, 2017 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today released a clinical update on its ongoing Phase I/IIa study of its lead vaccine candidate, BriaVax™, in advanced breast cancer patients.

The Phase I/IIa study evaluates the safety and activity of BriaVax™ in patients with advanced breast cancer. To boost the anti-tumor effects of BriaVax™, the patients are pre-treated with low dose cyclophosphamide and post-vaccine interferon-α2b {Intron A; manufactured by Merck & Co., Inc. (NYSE:MRK)}. At the request of the FDA, the first three patients were dosed sequentially with a sufficient amount of time between patients to evaluate any potential safety issues from the vaccine. That portion of the study was completed in September 2017, and the study was opened to additional patients marking the beginning of the Phase IIa portion of the study.  So far, an additional 3 patients have been enrolled and dosed with BriaVax™, bringing the total number of patients dosed to date to 6. 

Recruitment continues to proceed as projected, despite the challenges presented in recruiting late stage cancer patients. The study remains on track to announce data on the first 10 patients in the first quarter of 2018. The development of BriaDx™, a companion diagnostic test to identify the patients for whom BriaVax™ treatment would be most effective, is proceeding in parallel to this study. BriaCell has generated intriguing preliminary data that appears consistent with the observations from the Phase I pilot study previously performed by Dr. Wiseman, BriaCell’s scientific founder.

Patients who develop progressive disease during the BriaVax™ phase I/IIa study are eligible to participate in the BriaVax™ roll-over combination study (listed in ClinicalTrials.gov as NCT03328026) which evaluates BriaVax™ in combination with either pembrolizumab [Keytruda; manufactured by Merck & Co., Inc. (NYSE:MRK)] or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company (NYSE:BMY)]. These FDA-approved immune checkpoint inhibitors are expected to boost the anti-tumor activity of BriaVax™ thereby providing additional clinical benefit to the patients. Enrollment in the roll-over study may commence as early as first quarter of 2018. 

BriaVax™ is currently being investigated in three (3) US-based clinical sites, recruiting patients for the Phase I/IIa and roll-over combination studies. The sites include: 1) Santa Rosa, St. Joseph Health-Sonoma County, CA, 2) Florida Cancer Care, Plantation, FL, and 3) The Everett Clinic and Providence Regional Medical Center, Everett, WA. These sites are working closely with Cancer Insight, LLC, BriaCell’s contract research organization. Additional sites are planned to be opened over the course of the coming months.