3 excellent questions .....who's man enough to call in, que up and when connected (remember the whole board will be listening) grill Punit ?
I listened to some of the Stifel Healthcare conf. earlier - The extension trial, began last March. At the 12:25 mark ..."it's expected to complete enrollment by the end of next year" .. 21 patients ! 1 patient per month? That's not good enough. Do not defend the company. It's bull. 2 patients a month, trial is enrolled this year.
The design of the PhIIB,- It will have an increased dosing frequency... . (guarantee #6)
As far as announcing a trial in a new indication , ....At the 6 min mark .. . .
" ...other indications we're interested in exploring beyond skin cancer and you'll see one or more of these trials come online in the next 12 months"
imo, question #3 , the answers are a watershed moment for Oncs. Glta
a section of the Oncs p.r. dated June 10, 2011 ,.they also discuss biomarkers. Hello PerkinElmer.
In this Phase I trial, the experimental regimen was safe and well tolerated, with minimal systemic toxicity. Local treated lesions were biopsied and showed that 76% of all samples had at least 20% necrosis of the tumor, with 34% of those lesions showing 100% necrosis (clearance of the tumor). Furthermore, patients with additional tumors beyond the treated tumor were followed to determine regression of distant untreated lesions. Results demonstrated that 10 (53%) of 19 patients with distant untreated lesions showed at least stable disease or objective (partial or complete) regression. In addition, 15% of these patients demonstrated 100% clearance of distant, untreated metastatic melanoma tumors; by comparison, only 0.25% of such tumors would normally be expected to clear on their own if left untreated. The observed tumor regression of untreated lesions suggested a systemic immune response to the localized treatment . .. .. . .
- 15% of these patients demonstrated 100% clearance of distant, untreated .............tumors.
- observed tumor regression . .. . . . .suggested a systemic response ......
The abstracts this week; looking for confirmation of data followed by spike in share price.
“This collaboration with Dr. Algazi and UCSF with support from Merck marks the first clinical trial to evaluate the combination of an anti-PD-1 antibody with an intratumoral therapy using electroporation. Over the course of the last year, OncoSec has continually stated the need to evaluate intratumoral therapies that have the ability to convert the anti-PD-1 non-responder population to responders. The design of this clinical trial . . ." said PD-1 ......Umm, err....said Punit Dhillon, CEO.
"The design of this clinical trial" ----- No Guessing Allowed ! Guti, you own the investigative journalism award, I'm counting on you .
1) the original 30 patient regimen
2) the 21 patient extension trial. (increased dosing schedule)
With today's news , 236 million shares can be put up for sale on the open market. Ouch. Surprisingly, yesterday's volume was less than 3 per cent of the float and we closed up 15%. Nice. Four more milestones, . .. .we close the year___ .75
- - - - - SYSTEMIC IMMUNE RESPONSE - - - - -
There will be a r/s announced at next summer's annual meeting. This spring shareholders will vote on officers and a r/s option, ie: 1 for 4, 1 for 6, etc. --- Ino did this last spring, now it's Oncs turn. The r/s option ALWAYS gets a yes vote. With rare exception. 300 MILLION fully diluted shares ! Punit will go with 1 for 10.
I'm out Dec./Jan ......next up . . - AERI - ph III trials, float of 12 Million shares.
Punit's reply set the stage. I knew they couldn't plan partnership announcement and 1st patient enrolled on the same day. No company could time that. He did say 1st enrollment Jan. is possible. That leaves us with a Partnership announcement first and the trial design (protocol, # of patients, etc.) in the same p.r.- . .. ..forget my earlier post, Oncs working on the 'fine print' with PD-1 supplier.
the (speculative) weasl.
i just listened to the call - Punit would make a great poker player : ) , the guessing is still front and center.
..ever the optimist = currently talking to the 3 PD-1 players, the highest bid wins(?)
Last March Oncs announced the 'expansion trial' , up to 21 patients ......'to evaluate an increased dosing frequency in an expansion of it's ongoing ph II melanoma trial'
Results from this 21 patient trial have not been released. From a common sense standpoint, Oncs must have the results in hand....otherwise why start the ph IIB ? The increased dosing schedule could show a much higher response (efficacy) than the original 30 patient trial.
The best case scenario - increased efficiency, the data secures a PD-1 partner, the trial protocol is set .. . and Merck funds the new ph II ........and we get cash up front......and we get large percentage of royalties ....and .... .share price busts through $1 .. . ...
it's called going out on a limb. . . . . . . . . . . . . .
1) trial begins without partnership
2) p.r. announcing 1st patient enrolled (start of ph2B) will not name supplier of PD-1.
the (village idiot?) weasl . . .. .. .answers soon enough.
- " the benefit was just barely statistically signicant with a P value of 0.049 "
- " Roche's AURELIA study is much larger and the data more reliable. Oxigene's data are derived from a small subset of 27 platinum-resistant patients. Given the small size of the phase II, I suspect the fosbretabulin results will regress further when phase III results are eventually reported."
"results will regress further when phase III results are ....reported."
A ph III using all OC patients is a fail - This is why the stock is selling down. Investors who tell themselves "market manipulation', "shorts are holding this down".....Good luck.
Approval is at least 3 yrs away, if at all. Looking closely at the ph II results, this is not a good investment. Not anymore......anything over $2 I sell......took a chance on readout .. . ..glta.
- post-hoc subgroup analysis- ...can't believe GOG didn't design trial with 'pre-specified subgroup' ....Oxgn should know better. .....They never realized there could be a difference in response ?...geeze
In the design and analysis of experiments, post-hoc analysis (from Latin post hoc, "after this") consists of looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely something will be found . .....Wiki.
- Subgroup analysis of GOG1862 Study Showed benefit . . . . . .
Oxgn has a headline at the top of the p.r. that investors run from, big money and retail. The term 'subgroup' is associated with 'data mining'.....used by small bio's looking to bolster the final data readout. The p value .049, for all patients just got under the stat sig requirement of .05 - Increasing the 'N' in a ph III will lower the final 'P' value. Wall street is well aware of that. Espr announced p= 0.001 in their ph II, stock doubled.
In a post-hoc subgroup analysis, data showed that patients who were platinum-resistant also had a statistically significant improvement in PFS with the combination. Among these 27 patients, median PFS was 6.7 months for those on bevacizumab and fosbretabulin compared to 3.4 months for those receiving bevacizumab alone (p=0.01
Oxgn must design a ph III using this subgroup in their primary endpoint. P=0.01 will not fail in the larger trial. Will they ? They better. Large pharma won't like the idea. They are greedy for $$$. Getting Z approved for 25% of the OC patient population .....BP won't like it , I don't care, too bad. Enrolling all ovarian patients is fine, the benefit of Z should not be withheld based on platinum status.
ps- the potential revenue and current market cap [45M] .., I have never seen such a discrepancy in bio.
for the first time could kei. be right ? "imo, this sunday's presentation is not a major catalyst"
that in itself is worthy of a pr ... .. . . [hey kei. , just kiddin]
if you guys don't mind.....a third possibility - (the ceo at the time of pr..... now gone)
Maybe,,,,Oxgn was told of the stat sig 2 sided .10 , and in there infinitesimal wisdom, got real stupid. The whole bio investing world looks for the 1 sided .05 as the stat sig standard.
Did Oxgn decide to 'dumb down' the .10 result, putting .05 in their p.r ...... ? The company should responded to the SA article.