Replies to post #1191 on NightHawk Biosciences Inc (NHWK)

[Golf4Food]

Thanks for info... HTBX up this morning ;)

[pix]

Are this the results?

[dia76ca]

We have to wait to see what the results are from each arm of the Bladder cancer trial. All we know is that the "...composite RFS across all arms was 84.6%" and that the combination of BCG and HS-410 had a "synergistic effect". So the results could look like this...

BCG plus placebo.................RFS 75%
BCG plus low dose HS-410....RFS 85%
BCG plus high dose HS-410...RFS 95%

This would give a composite RFS across all arms of 85% assuming that the "synergistic effect" meant that the combination arms had a better result than the placebo arm.

We should also note the 6 month complete response rate in CIS patients of 87.5%...this is remarkable!

[jboatswain]

HS-410 + BCG Combo and Mono


78 patients with intermediate (n=5) or high-risk (n=73)
BCG-naïve or recurrent: naive (never treated with BCG before); recurrent (treated with BCG before)
NMIBC split: 50% low-risk + 20% high-risk + 30% intermediate-risk
Intermediate/high-risk: high-grade Ta; T1; CIS (from HTBX docs)
Intermedia-risk: recurrence main problem
high-risk: progression main concern; progression rate as high as 45%

High-grade bladder cancer commonly recurs in the bladder and also has a strong tendency to invade the muscular wall of the bladder and spread to other parts of the body. High-grade bladder cancer is treated more aggressively than low-grade bladder cancer and is much more likely to result in death. Almost all deaths from bladder cancer are due to high-grade disease.

Now you can see that HTBX is mainly targeting. The critics of the abstract are bringing in the average RFS that includes low-risk, low-grade NMIBC.

Look at what Ta, T1 and CIS refer to:





RFS from a large EORTC 30962 trial:



1 year RFS from the above: 57.2%, lets round it to 60%, compare that with "Composite RFS across all arms (prior to the unblinding event at 1-year) was 84.6%"

Carcinoma in Situ (CIS):

- CIS has a high risk of progression to muscle-invasive disease which exceeds 50% in some studies
- 6-month complete response rate in CIS patients of 87.5%. (from the abstract)
Complete response = no evidence of disease. With BCG, you look for evidence at 3 months. Sounds like it look 6 months for CIS, instead of the usual 3 months.

Whenever there is CIS, it increases the risk of recurrence. This could be concomitant (CIS + T1/Ta; CIS+T1+Ta).

Since HTBX is going for high risk patients, some with CIS, it is kind of hard to predict the historical RFS with BCG. That's why urologists are given a table to calculate weights to predict recurrence.

Here is the table:


Here are estimated RFS based on adding weights you can get based on the type/grade/risk bladder cancer.


HS-410 Mono arm:

We gonna get 6 month top line data soon. Hopefully on Nov 30, as it is mentioned in the abstract. It is investigated by the same lead investigator Dr Gary S.

You can see the 3 months interim data here: