Burzynski: Phase II Clinical Trials Preliminary Reports

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(as of 2/28/2013)
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2013 – Protocol # BT-06 children with high grade glioma
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19 – Patients Accrued
11 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
7 / 63.7% –
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# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
4 / 36.4%
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# and% of Patients Showing Complete Response
——————————————————————
2 / 18.2%
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# and % of Patients Showing Partial Response
——————————————————————
2 / 18.2%
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# and % of Patients Showing Stable Disease
——————————————————————
3 / 27.3%
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# and % of Patients Showing Progressive Disease
——————————————————————
4 / 36.4%
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2013 – Protocol # BT-07 patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy
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40 – Patients Accrued
24 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
6 / 25%
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# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
3 / 12.5%
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# and% of Patients Showing Complete Response
——————————————————————
2 / 8.3%
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# and % of Patients Showing Partial Response
——————————————————————
1 / 4.2%
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# and % of Patients Showing Stable Disease
——————————————————————
3 / 12.5%
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# and % of Patients Showing Progressive Disease
——————————————————————
18 / 75.0%
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2013 – Protocol # BT-08 patients with anaplastic astrocytoma
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19 – Patients Accrued
14 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
10 / 71.5%
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# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
4 / 28.6%
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# and% of Patients Showing Complete Response
——————————————————————
4 / 28.6%
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# and % of Patients Showing Partial Response
——————————————————————
0 / 0.0%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
6 / 42.9%
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# and % of Patients Showing Progressive Disease
——————————————————————
4 / 28.6%
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2013 – Protocol # BT-09 patients with brain tumors
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40 – Patients Accrued
28 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
22 / 78.6%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
9 / 32.2%
======================================
# and% of Patients Showing Complete Response
——————————————————————
4 / 14.3%
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# and % of Patients Showing Partial Response
——————————————————————
5 / 17.9%
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# and % of Patients Showing Stable Disease
——————————————————————
13 / 46.4%
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# and % of Patients Showing Progressive Disease
——————————————————————
6 / 21.4%
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2013 -Protocol # BT-10 children with brain tumors
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34 – Patients Accrued
26 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
14 / 53.9%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
6 / 23.1%
======================================
# and% of Patients Showing Complete Response
——————————————————————
2 / 7.7%
======================================
# and % of Patients Showing Partial Response
——————————————————————
4 / 15.4%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
8 / 30.8%
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# and % of Patients Showing Progressive Disease
——————————————————————
12 / 46.2%
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2013 – Protocol # BT-11 patients with brainstem glioma
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40 – Patients Accrued
28 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
21 / 75.1%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
9 / 32.2%
======================================
# and% of Patients Showing Complete Response
——————————————————————
5 / 17.9%
======================================
# and % of Patients Showing Partial Response
——————————————————————
4 / 14.3%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
12 / 42.9%
======================================
# and % of Patients Showing Progressive Disease
——————————————————————
7 / 25.0%
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2013 – Protocol # BT-12 children with primitive neuroectodermal tumors (PNET)
======================================
13 – Patients Accrued
11 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
7 / 62.7%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
4 / 36.4%
======================================
# and% of Patients Showing Complete Response
——————————————————————
3 / 27.3%
======================================
# and % of Patients Showing Partial Response
——————————————————————
1 / 9.1%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
3 / 27.3%
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# and % of Patients Showing Progressive Disease
——————————————————————
4 / 36.4%
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2013 – Protocol # BT-13 children with low grade astrocytoma, a type of PMBT
======================================
17 – Patients Accrued
14 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
12 / 85.7%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
7 / 50%
======================================
# and% of Patients Showing Complete Response
——————————————————————
6 / 42.9%
======================================
# and % of Patients Showing Partial Response
——————————————————————
1 / 7.1%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
5 / 35.7%
======================================
# and % of Patients Showing Progressive Disease
——————————————————————
2 / 14.3%
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2013 – Protocol # BT-15 adult patients with anaplastic astrocytoma, a type of PMBT
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27 – Patients Accrued
20 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
14 / 70%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
5 / 25%
======================================
# and% of Patients Showing Complete Response
——————————————————————
3 / 15.0%
======================================
# and % of Patients Showing Partial Response
——————————————————————
2 / 10.0%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
9 / 45.0%
======================================
# and % of Patients Showing Progressive Disease
——————————————————————
6 / 30.0%
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2013 – Protocol # BT-18 treatment of “mixed glioma,” a type of PMBT
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20 – Patients Accrued
13 – Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
7 / 53.9%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
4 / 30.8%
======================================
# and% of Patients Showing Complete Response
——————————————————————
3 / 23.1%
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# and % of Patients Showing Partial Response
——————————————————————
1 / 7.7%
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# and % of Patients Showing Stable Disease
——————————————————————
3 / 23.1%
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# and % of Patients Showing Progressive Disease
——————————————————————
6 / 46.2%
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2013 – Protocol # BT-20 patients with glioblastoma multiforme, which recurred after standard radiation and/or chemotherapy
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40 – Patients Accrued
22 – Evaluable Patients
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# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
16 / 72.6%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
2 / 9%
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# and% of Patients Showing Complete Response
——————————————————————
1 / 4.5%
======================================
# and % of Patients Showing Partial Response
——————————————————————
1 / 4.5%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
14 / 63.6%
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# and % of Patients Showing Progressive Disease
——————————————————————
6 / 27.3%
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2013 – Protocol # BT-21 adults with primary malignant brain tumors
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40 – Patients Accrued
23- Evaluable Patients
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# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
13 / 56.5%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
4 / 17.4%
======================================
# and% of Patients Showing Complete Response
——————————————————————
2 / 8.7%
======================================
# and % of Patients Showing Partial Response
——————————————————————
2 / 8.7%
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# and % of Patients Showing Stable Disease
——————————————————————
9 / 39.1%
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# and % of Patients Showing Progressive Disease
——————————————————————
10 / 43.5%
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2013 – Protocol # BT-22 children with primary malignant brain tumors
======================================
43 – Patients Accrued
27- Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
14 / 51.9%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
5 / 18.6%
======================================
# and% of Patients Showing Complete Response
——————————————————————
1 / 3.7%
======================================
# and % of Patients Showing Partial Response
——————————————————————
4 / 14.8%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
9 / 33.3%
======================================
# and % of Patients Showing Progressive Disease
——————————————————————
13 / 48.1%
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2013 – Protocol # BT-23 children with visual pathway glioma
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16 – Patients Accrued
12- Evaluable Patients
======================================
# and % of Patients Resolving or Stabilizing Disease = Complete Response + Partial Response + Stable Disease
——————————————————————
11 / 91.7%
======================================
# and % of Patients Showing Objective Response = Complete Response and Partial Response
——————————————————————
5 / 41.7%
======================================
# and% of Patients Showing Complete Response
——————————————————————
3 / 25%
======================================
# and % of Patients Showing Partial Response
——————————————————————
2 / 16.7%
======================================
# and % of Patients Showing Stable Disease
——————————————————————
6 / 50.0%
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# and % of Patients Showing Progressive Disease
——————————————————————
1 / 8.3%
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Phase II Study
Protocol CAN-1
35 evaluable brain tumor patients

Complete and partial responses
patients diagnosed with
glioblastoma multiforme
astrocytoma
oligodendroglioma
mixed glioma
medulloblastoma
malignant meningioma
——————————————————————
Antineoplastons A10 and AS2-1
17 / 48.6% – objective responses
11 / 31.4% – stable disease
(28 / 80.0)
(7 / 20%)
——————————————————————
largest group of evaluable patients had glioblastoma multiforme
——————————————————————
6 / 17% – complete and partial responses
4 /11% – obtained stabilization
4 /11% – developed progression of disease
(21 / 39%)
(14 / 61%)
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5/29/2013 Form 10-K
http://www.faqs.org/sec-filings/130529/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/
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