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Ad-RTS-hIL-12 and veledimex didnt work for recurrent / metastatic breast CA, with only one of 12 having a response. As an aside, if the clinical trials webpage has not been updated & the trial is completed, its likely a negative trial. This was considered a Phase 2 study with a whole twelve patients. Let me repeat that.

Phase two. For breast cancer. Twelve patients. (1,2)

There are 40,000 patients that die each year from breast CA (3), so there are (probably) about that many stage 4 breast CA patients out there. They can only get 12 patients? They have another 40 patient trial that is not actively recruiting, so I suspect they gave up. (4) This tends to be a common theme for them, since they did it with melanoma as well. (5)

ZIOP is losing 15m quarterly, with 81m cash on hand, leaving them essentially nothing by the time their GBM results come in - a whole 48 patient trial that is not due until 2019. (6) There are 74,000 people worldwide each year, and all they can come up with for a trial is 48 patients since 2015? And we keep clinging to a single center, single arm P1 study with an N of 7 ??? and with 17 overall patients?? (7) Though yes, they are doing a multi-center trial (at a while 4 sites) – its still a P1 trial (with a whopping 48 patients!) which by definition, is looking at safety profile and not ORR, OS, or PFS. (8) …. The N of 48 is about 25% that of other studies looking at GBM.

Now, lets move onto the excitement of a point-of-care system with 2 day turn around... Sleeping Beauty! … Sleeping beauty is still asleep, as it hasnt even been used clinically yet! “The Company expects to advance towards a Phase 1 study evaluating the point-of-care in 2017. “ (9) Basically, all of the money they have spent on the prior studies needs to be repeated with the Sleeping Beauty system.

Not to mention that this is delivered by intra-tumoral injection- can these brain tumors even be reached? - who's going to inject them??? How the hell are you going to practice? will it be reimbursed? Will parents balk at the thought of having an unproven drug injected into their kids brain??? New drug, new delivery mechanism, unproven / low quality data.... This is worse than Afrezza!

Then there's this (10):

Intra-tumoral IL-12 RheoSwitch® programs:  
-  Updated clinical data from Phase 1 of Ad-RTS-hIL-12 + veledimex for recurrent GBM to be presented at ASCO 
-  Initiate pivotal clinical trial for recurrent GBM 
-  Initiate combination study of Ad-RTS-hIL-12 + veledimex with iCPI (anti-PD-1) for recurrent GBM during the first half  
-  Initiate Phase 1 study in the treatment of brain tumors in children during the first half 
  
CAR+ T programs: 
-  Continue CD19-specific CAR+ T second-generation clinical study, enrolling patients under shortened manufacturing
-  Advance CD19 third-generation mbIL15 towards a Phase 1 clinical study evaluating point-of-care 
-  Initiate a CD33-specific CAR+ T clinical study in adults and children for relapsed or refractory acute myeloid leukemia 
-  Advance CAR+ T-cell preclinical studies for at least one hematological malignancy under a shortened manufacturing process towards point-of-care
  
TCR programs 
-  Execute CRADA with NCI utilizing Sleeping Beauty to generate T cells targeting neoantigens for treatment of patients with solid tumor malignancies 
-  Advance development of process for delivering personalized gene-modified T-cell products against neoantigens  
NK cell programs  
-  Initiate a Phase 1 study of off-the-shelf (OTS) NK cells for elderly patients with acute myeloid leukemia not eligible for standard intensive chemotherapy 
GvHD (graft-versus-host disease) programs 
-  Advance preclinical studies
Too many shots on goal, not enough money to go around. This shows a lack of focus, and is an attempt to put lipstick on a pig that has failed in 2 other arenas (breast CA & melanoma) already.

Then there is the dilutional issue with intrexon. (11,12)

Too many moving parts, not enough data, not enough focus, intrexon seems like a shady business partner....

ZIOP is a penny stock, it just doesnt realize it yet.



(1) https://www.fool.com/investing/2016/08/30/ziopharm-has-a-dat...

(2) https://clinicaltrials.gov/ct2/show/NCT01703754?term=veledim...

(3) https://www.cancer.org/content/dam/cancer-org/research/cance...

(4) https://clinicaltrials.gov/ct2/show/record/NCT02423902?term=...

(5) https://clinicaltrials.gov/ct2/show/NCT00815607?term=ziophar...

(6) https://clinicaltrials.gov/ct2/show/NCT02026271?term=veledim...

(7) http://ir.ziopharm.com/releasedetail.cfm?ReleaseID=999896

(8) https://clinicaltrials.gov/ct2/show/NCT02026271?term=ziophar...

(9) https://www.thestreet.com/story/14112280/2/ziopharm-oncology...

(10) http://ir.ziopharm.com/releasedetail.cfm?ReleaseID=1023789

(11) https://www.fool.com/investing/2016/07/11/heres-why-ziopharm...

(12) https://www.fool.com/investing/2016/07/06/intrexon-just-dilu...
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