FDA Commissioner’s comments
C-SPAN
Today
THE WHITE HOUSE
WASHINGTON
DAVID KESSLER
FDA COMISSIONER
CANCER DRUG TREATMENT APPROVAL PROCESS
March 29, 1996
4:17 – 6:17
We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators
I’d be happy to take a few questions
QUESTION:
Yes I … Will uhh … FDA’s initiatives …
that you announced today expedite the current review of antineoplastons … treatments
ANSWER:
The … FDA’s initiatives … will allow …
the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
We will accept … less information … up front – we’re going to require further study AFTER … approval … because the science … has matured
The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works
QUESTION:
Will will patients uhh who have taken other forms of of … of cancer treat – treatments; chemo or radiation treatments … uhh be allowed to participate for trials of antineoplastons
ANSWER:
The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons
We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
6:17
2003 – 2007 Phase II preliminary
2003 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
recurrent diffuse intrinsic brain stem glioma
Phase 2
phase II
antineoplaston A10 and AS2-1
6 months median duration of treatment
of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis
from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than
Only mild and moderate toxicities were observed, which included
3 cases of skin allergy
2 cases of:
anaemia
fever
hypernatraemuia
single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting
2003
Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
2004 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
incurable recurrent and progressive multicentric glioma
antineoplaston A10 and AS2-1 (ANP)
9 – patients’ median age
6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location
16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP
1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later
10 patients are alive and well from 2 to >14 years post-diagnosis
Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described
2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
13 children with recurrent disease or high risk
6 (46%) survived more than 5 years
2005
Protocol – recurrent disease or
high risk
– Patients Accrued
– Evaluable Patients
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease
2006 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
Brainstem glioma carries the worst prognosis of all malignancies of the brain
Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years
Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials
39% – overall survival at 2 years
22% – overall survival at 5 years
17+ years maximum survival for a patient with anaplastic astrocytoma
5+ years for a patient with glioblastoma
39% – Progression-free survival at 6 months
5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients
18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG
14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy
Antineoplastons, A10 (A10I) and AS2-1 injections
5 months median duration
Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography
Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)
2006
Protocol – high-grade pathology (HBSG)
– Patients Accrued
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease
FDA Commissioner David Kessler
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