RE:Ph 1b patients #5 and #6 still cancer free after 2 yearsIn fact, both ph. 1b patients #5 and #6 have now reached their 3y+ milestone, as we speak, as the statement below was dated of August 2021 and that p#6 reached 540 days on Sept. 30, 2019, so initially treated around April 8, 2018.
It's impossible that the FDA pass over such a treatment and not grant us Breakthrough designation and Accelerated Approval program, especially that this is for a late stage cancer where patients have no options, as per Dr. Kulkarni stated in hte latest news release.
Over the next few weeks, ImmunityBio will be granted FDA approval but they still rely on BCG and they have something like 12 treatments. If our next round of data looks good on the optimized patients group (we still have 11 pending patient results to come, out of 15), then we will be a much better option than ImmunityBio.
May 23, 2022 -
where 71% of patients who had failed on previous therapies showed an over 50% increase in both response and median duration compared to the FDA-approved alternatives Valrubicin and Pembrolizumab BCG+N-803 BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, & 18 months.
An additional 6 week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.
Theralase treatment is only 2 doses! Imagine if we hit higher efficacy %.
________________________
ScienceFirst - (6/22/2022 9:05:27 AM)
Ph 1b patients #5 and #6 still cancer free after 2 years
« … with patients five and six demonstrating CR with no presence, recurrence or progression of the disease at up to 24 months post treatment."
All this, with one dose!
The holy grail of oncology;
- high efficacy,
- low number of treatments (1 in our case)
- no side effects,
- total destruction of the late-stage solid tumor.
You cannot ask for anything better than that.