Update on POH for G...
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Update on POH for GMB: Promising results from NeOnc Technologies, Inc.

Joined: 6 years ago
Posts: 1012
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Nearly 4 years ago, I discussed POH here https://www.cancertreatmentsresearch.com/perillyl-alcohol-poh/

Recently, NeOnc Technologies, Inc., published results on clinical trials where POH was used as an intranasal treatment for GMB patients indicating 67% response (POH dose of 192 mg/dose 4 times a day) :

NeOnc Technologies, Inc.’s phase one clinical trial is fully subscribed and is progressing with encouraging results. NTI is preparing to begin recruiting for Phase 2 which should begin in July 2019. The phase 1 study was a dose escalation study.

Cohort 1: 96 mg/dose 4 times a day (384 mg/day total)
• Brazilian dose 440 mg/day.
Cohort 2: 144 mg/dose 4 times a day (576 mg/day total)
Cohort 3: 192 mg/dose 4 times a day (768 mg/day total)
Cohort 4: 288 mg/dose 4 times a day (1152 mg/day total)

Key results
1. NEO100 has induced a radiographic reduction in size in recurrent GBM in a dose-dependent manner in several patients
2. NEO100: very well tolerated
• no significant adverse effects
3. Patients tolerate treatment regimen very well (compliance by patient log and self-reporting)
{Regimen is a 4x/day for 28 days}
4. Higher doses of NEO100 result in a higher response in patients over six months

• Cohort 1 – no response (0/3)
• Cohort 2 – 33% response (1/3)
• Cohort 3 – 67% response (2/3) – one has a complete radiographic response
• Cohort 4 - underway

Individual Cohort Results – note results between cohorts vary because dose escalated from cohort to cohort for toxicity assessment and improved therapeutic outcome evidenced with higher dose cohorts.

Cohort 1, Phase I
1. No significant adverse effects
2. All patients had a progression of tumor size after two months.
3. MRI scans from two of the patients demonstrated a change from solid to cystic tumor
4. 0 % response rate
• Two of the patients had repeat surgery
• A change in characteristics of the tumor,
• A decrease in Ki-67 for both tumors

Cohort 2, Phase 1
1. First patient-progressed after two months
2. Second patient-2 years of treatment
• still alive
• no seizures (prior to treatment 2-3 seizures per week, mostly partial but some generalized)
• tumor smaller on MRI
• the patient is continuing on therapy
3. Third patient-progressed after four months
4. 33% response rate after six months

Cohort 3, Phase 1
1. Cleveland Clinic-1 patient-one year out
• complete response
2. USC-1 patient –one year out
• no progression
• reduction in tumor size
3. USC 1 patient-3 months out-stable
4. 67% response rate over six months

Results-Cohort 4, Phase 1
• Three patients recruited
• Two at one month of treatment
• One just started treatment

Reference: https://www.facebook.com/neonctech/


Joined: 4 years ago
Posts: 93

The trial is recruiting https://clinicaltrials.gov/ct2/show/NCT02704858

Daniel liked
Joined: 4 years ago
Posts: 93

From the company's Facebook page they state, ''Phase 2 has three patients enrolled. Two are through 2 cycles and the third is through cycle 1. Very encouraging results.''

Joined: 4 years ago
Posts: 93

The PhII is ongoing, with data for both endpoints expected this year.


Also, a new paper. From it: ''Intranasal NEO100 was well tolerated at all dose levels and no severe adverse events were reported. PFS-6 was 33%, OS-12 was 55%, and median OS was 15 months. Four patients (33%), all of them with isocitrate dehydrogenase 1 (IDH1)-mutant tumors, survived >24 months.'' https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879254/