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1
Outline ( 1
)
BRM has a molecular target-taxis diphasic broad spectrum
anti-cancer action, like chemotherapeutic drug, killing
cancer cells directly and enhancing immunity of the body
as well, thus lead to an improvement of the clinical
symptoms
2
Outline ( 2 )
Hundreds of study reports published in China indicate that BRM
mainly has following efficacies :
When BRM is used singly in treating cancers, it has obvious
therapeutic effect to many primary malignant tumours such as lung
cancer, hepatic cancer, gastric cancer, mastocarcinoma, etc, and
can enhance immune function of human body, improve patients’
survival quality and prolong their survival period ;
When BRM is used in combination with chemotherapy , radiotherapy and
intervening therapy, it can increase the clinical curative effect by about one
time and remit toxic and side effects caused by radio/chemotherapy.
3
Preoperative use of BRM may facilitate the liquification and
4
(1) A Survey to the Clinical
Trial
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1. About China phase Ⅲ clinical trial
6
1. About China phase Ⅲ
clinical trial
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( 1) BRM used solely in the treatment of primary
lung cancer
8
Phase Ⅲ Clinical Trial on
Treatment of Primary Lung Cancer
Comparison of Therapeutic Effect
*compared with
chemotherapy P>0.05
9
( 2 ) BRM used solely in treatment of primary
hepatic cancer
Cancer Hospital, Chinese Academy of Medical Sciences conducted a BRM treatment of primary
liver cancer patients. The results showed that:
BRM effective rate of 11.43% of liver cancer, chemotherapy group (PAF program) effective rate
of 9.8% between the two groups no significant difference.
Test proved that BRM can significantly improve the symptoms of liver cancer patients and
improve the quality of life and immune function.
Tests also confirmed that, BRM without bone marrow suppression, liver and renal function no
obvious damage.
See only mild adverse reactions of nausea, fever, after stopping their own ease.
10
Phase Ⅲ Clinical Trial on
Treatment of Primary Hepatic
Comparison of Therapeutic Effect Cancer
Chemotherapy 91 1 5 6 20 20 9.80
PAF scheme
* Compared with
chemotherapy P>0.05
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( 3 ) BRM + Chemotherapy in the Treatment of NSCLC
12
Phase Ⅲ Clinical Trial on BRM +
Chemotherapy in Treatment of
NSCLC
Comparison of Effective Rate
13
( 4 ) Combination of BRM and surgery in the treatment of lung
cancer
The study of BRM preoperatively for the treatment of lung cancer was
carried out in Cancer Hospital, Chinese Academy of Medical Sciences
(CAMS) . the results showed:
The occurrence of large area necrosis of tumor tissue more than 25%
demonstrated by postoperative pathological examination in BRM group
being 62.22% (28/45), and that of the control group being 26.67% (8/30),
significant difference was present.
Among whom with necrotic area larger than 50% in the BRM group being
28.9% (13/45), and that of the control group being 13.3% (4/30), had
significant difference.
14
Phase Ⅲ Clinical Trial on BRM combined with
Surgical Operation in Treatment of Primary Lung
Cancer
Comparison of the necrosis area between the tumor specimen
of the two groups
Group Case Necrotic area Effective
rate ( % )
( necrotic area
<25% 25~50% 50~70% >25% )
BRM 45 17 15 13 62.22*
Control 30 22 4 14 26.67
15
( 5 ) BRM + Radiotherapy in Treatment of Malignant
Tumors
16
Phase Ⅲ Clinical Study on BRM +
Radiotherapy in Treatment of Malignant
Tumors
Group Case CR PR SD+PD Effective rate (%)
Control 86 16 36 34 60.47
17
( 6) Combined BRM intervention therapy in the
treatment of primary hepatic cancer and primary
lung cancer
This treatment in patients with primary lung cancer or primary hepatic cancer,
the results showed:
18
Phase Ⅲ Clinical Trial on Combined BRM
Intervention Therapy in Treatment of
Primary Hepatic Cancer and Primary
Lung Cancer
Group Scheme Case PR MR SD PD Effective
rate
(%)
Hepatic BRM+ 130 4 86 24 16 69.23*
cancer Chemotherapy
Sole 68 1 25 22 20 38.24
chemotherapy
Sole 76 2 20 43 11 28.95
chemotherapy
19
( 7 ) BRM Can Control Cancer Pain and Improve the Survival Quality
of Advanced Cancer Patients
BRM can effectively control cancer pains and improve survival quality of advanced cancer
patients :
By BRM therapy , the pain remission rate among 328 patients with cancer pain
reaches 80.49 %( PR of 56.1 %, CR of 24.39 %) .
By BRM therapy, among patients with different degree of pains (slight, moderate ,
severe ) , 100 % patients with slight pain can be controlled (62/62) , 86.18 % with
moderate pain ( 131/152 ) is remitted , and 62.28 % with severe pains is
( 71/114 )
20
Clinical Trial on Improvement of
Survival Quality of Advanced Cancer
Patients
Effect of BRM to survival quality score of Advanced Cancer Patients
0 5 10 15 20 25
Case 33 70 97 88 68 20
After therapy by BRM, 91.22% ( 343/376 ) of the patients see survival quality score
increase, and those whose score increased by 10 points accounting for
72.61% ( 273/376 )
21
Phase Ⅲ Clinical Trial of Cancerous Pain Control
of Advanced Cancer Patient
Relief degree of cancerous pain after BRM therapy
Pain Case Pain-relieving degree Remission
degree rate
0 1 2 3 4 ( 100% )
Slight 62 0 0 0 0 62 100
The overall effective rate of pain control after BRM therapy reaches 80.49% ( partial relief
56.10% , complete relief 24.39% ), and the pain-relieving effect can last about 1-7 days after
withdraw of BRM, and no habituation occur. Therefore, BRM can partially or totally replace
morphine or morphine like analgesics.
22
2. About China Phase Ⅰ Clinical
Trial
23
China Phase Ⅰ Clinical Trial
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Test Results of BRM Toxicity
I ( 2.4g/d ) 3 3 0 0
II ( 3.6g/d ) 3 3 0 0
III ( 4.8g/d ) 4 3 0 1
IV ( 5.4g/d ) 3 3 0 0
V ( 6.0g/d ) 2 2 0 0
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3. About China Phase Ⅱ
Clinical Trial
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About China Phase ⅡClinical Trial
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Summary of China Phase Ⅱ Clinical Trial
Conclusion
● The trial demonstrates the BRM effect in treatment of NSCLC.
29
2. New progress of domestic
and foreign basic research
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1. Previous Study Results
The study results of top research bodies such as Chinese
Academy of Medicine Sciences Tumor Hospital show that the
anti-tumors mechanism of BRM involves the following
aspects :
31
BRM 抗癌作用机理研究
32
Inhibit of BRM to the Activity of Protein
Kinase C
20
containing cell-dissolved products
82
1-
nM
-3
Ro
20
K
K
0K
00
er
uM
50
l
/m
l
/m
st
+1
+1
+2
+
ul
le
ul
e
l
50
e
ro
bo
e
0
id
id
id
id
T1
nt
pt
or
pt
T
pt
pt
Co
KL
KL
Pe
Ph
Pe
Pe
Pe
(-) (non-phosphopeptide)
(phosphopeptide)
(+)
33
BRM Inhibits the Activity of Metalloprotease-9(MMP-9)
20 nM Phorbol
0 0 10 35 50
20 nM Phorbol
0 0 10 35 50
MMP-9
BRM inhibits MMP-9
Activity (zymogram method)
MMP-2
34
BRM Inhibits the Attack of Tumor Cells
on Basement Membrane Matrix
Phorbol (20 nM) PHorbol (20 nM)+
BRM(1.2 ul/ml)
35
BRM Inhibits the Activity of Fatty Acid Synthase
(FAS).
。
36
BRM Inhibits the Activity of Fatty Acid Synthase
Blank control
BRM(2.4g)
14C acetate binding enters lipid
BRM(3.6g)
140
120
(% control)
100
80
60
40
20
0 hour
1 3 6 12 24 36 48 60 72