A summary of all various publications abstracts on LCS101.

1. RESEARCH
PUBLICATIONS
ABSTRACTS
For Botanical formula
LCS101(Commercialized as Protectival)
Medical Research Ltd.
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2. Medical Research Ltd.
A Prospective, Controlled Study of the Botanical Compound
Mixture LCS101 for Chemotherapy-Induced Hematological
Complications in Breast Cancer
Neora Yaal-Hahoshen, AYair Maimon, B,ENava Siegelmann-Danieli, DShahar Lev-Ari,
BIlan g. Ron, AFani Sperber, CNoah Samuels, FJacob Shoham, GOfer Merimsky
A. Department of Oncology, Tel Aviv Sourasky Medical Center affiliated with the Sackler Faculty of Medicine,Tel Aviv
University, Tel Aviv, Israel;
B. Unit of Complementary Medicine, Tel Aviv Sourasky Medical Center
C. Breast Imaging Unit, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel;
D. Maccabi Healthcare Services, Tel Aviv, Israel;
E. Refuot Integrative Medical Center, Tel Aviv, Israel;
F.Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel;
G.Faculty of Life Sciences, Bar-Ilan University, Ramat Gan, Israel
ABSTRACT
Background. This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of
botanical compounds known as LCS101 in preventing chemotherapy-induced hematological toxicity in breast
cancer patients.
Methods.
Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either
LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2
weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants
receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and
nonhematological toxicities, as well as the tolerability and safety of the study intervention.
Results.
Sixty-five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo
treatment. Patients in the treatment group developed significantly less severe (grades 2– 4) anemia (p < .01) and
leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04)
when comparing grades 0 –2 with grades 3–4. This effect was more significant among patients undergoing a
dose-dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and
side effect rates were not significantly different between the groups, with no severe or life-threatening events
observed in either group.
Conclusion.
The addition of LCS101 to anthracycline and taxane-based chemotherapy is safe and well tolerated, and may
significantly prevent some chemotherapy-induced hematological toxicities in early breast cancer patients. These
results should encourage further larger and more extensive clinical trials.
The Oncologist 2011; 16: 1197-1202
http://theoncologist.alphamedpress.org/content/16/9/1197.long
In reply
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3360915/

3. Medical Research Ltd.
Effect of Chinese Herbal Therapy on Breast Cancer
Adenocarcinoma Cell Lines
Y MAIMON1,2 , V KARUSH3 , N YAAL-HAHOSHEN3 , R BEN-YOSEF3, I RON3, A VEXLER3
AND S LEV-ARI1,3
1 Unit of Integrative Medicine, Tel Aviv Sourasky Medical Centre, Tel Aviv, Israel;
2 Refuot Medical Centre, Ramat Aviv, Israel;
3 Department of Oncology, Tel Aviv Sourasky Medical Centre affiliated with The Sackler
Faculty of Medicine, Tel Aviv, Israel
ABSTRACT
Despite the widespread use of medicinal herbs to prevent and treat many diseases, including cancer,
there are insufficient scientific data on the safety and efficacy of the majority of herbal therapies. The
aim of this study was to assess the effect of a unique Chinese herbal therapy (CHT) from controlled
manufactured concentrated powders, on an in vitro model of breast cancer. Three breast
adenocarcinoma cell lines (MDA-231, MDA-453, T47D) were exposed to CHT for 72 h. Cell viability
was assessed by XTT (sodium 3′-[1-(phenylaminocarbonyl)-3, 4-tetra zolium]-bis(4-methoxy-6-nitro)
benzene sulphonic acid hydrate) assay. Apoptosis and cell cycle stage were determined by
fluorescence-activated cell sorting (FACS) analysis. CHT decreased cell survival in a dose-dependent
manner in all tested cell lines. FACS analysis of treated and non-treated T47D cells demonstrated that
the inhibitory effect of CHT was associated with an increase in apoptosis. A randomized clinical trial
is currently underway to investigate CHT as supplementary therapy for breast cancer patients
receiving chemotherapy.
The Journal of International Medical Research 2010; 38:2033-2039
http://imr.sagepub.com/content/38/6/2033.abstract

4. Medical Research Ltd.
Immunomodulatory effects of the botanical compound
LCS101: implications for cancer treatment.
Rachmut I 1; Samuels N 2 (†co-first author); Melnick SJ 3; Ramachandran C 4; Sharabi Y 1; Pavlovsky A
1; Maimon Y 5; Shoham J1 .
1. Faculty of Life Sciences, The Gonda-Goldschmied Center, Bar-Ilan University, Ramat-Gan, Israel.
2. Center fr Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
3. Department of Pathology Miami Children's Hospital, Miami, Florida, USA.
4. Research Institute, Miami Children's Hospital, Miami, Florida, USA.
5. Refuot Integrative Medical Center, Tel Aviv, Israel.
ABSTRACT
Objective:
To examine the effects of LSC101, a botanical compound, on adaptive and innate
immunity.
Materials and methods:
LCS101 preparations were tested for batch-to-batch consistency using HPLC. T cell
activation was quantified in murine spleen cells using 3H-Thymidine incorporation,
and cytokine production analyzed with ELISA. NK cell activity was tested on human
blood cells using flow cytometry, and cytotoxicity measured by MTT and apoptosis
using a FACS caliber. Effects on interferon-γ production in 5-FU/doxorubicin- treated
mice were tested with ELISA.
Results:
HPLC analysis demonstrated batch-to-batch consistency. T cell proliferation was
increased, and a dose-dependent activation of NK cells and macrophage TNFα
secretion were observed with LCS101 treatment. IFN-γ levels, reduced by 5-FU
treatment, were corrected in treated animals. No toxicity or compromised treatment
outcomes were associated with LCS101 exposure.
Conclusions:
LCS101 demonstrated significant effects on a number of immune processes.
Further research is needed in order to understand the molecular immunomodulatory
pathways affected by this compound, as well as clinical implications for treatment.
OncoTargets and Therapy 2013:6 1–9
http://www.dovepress.com/articles.php?article_id=12857

5. Medical Research Ltd.
Effect of the Botanical Compound LCS101 on
Chemotherapy-Induced Symptoms in Patients with
Breast Cancer: A Case Series Report
Noah Samuels 1, Yair Maimon ( co-first author) 2; and Rachel Y. Zisk-Rony 3
1. Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
2. Refuot Medical Center, Tel Aviv, Israel.
3. Henrietta Szold Hadassah-Hebrew University School of Nursing, Faculty of Medicine and Hadassah-
Hebrew University Medical Center, Jerusalem, Israel.
ABSTRACT
The treatment of breast cancer invariably results in severe and often debilitating symptoms that can
cause significant distress and severely impair daily function and quality- of-life (QOL). We treated a
series of 20 female breast cancer patients with the botanical compound LCS101 as adjuvant to
conventional chemotherapy. At the end of the treatment regimen, patients rated their symptoms. 70%
reported that they had either no or mildly severe levels of fatigue; 60% none to mildly severe
weakness; 85% none to mildly severe pain; 70% none to mildly severe nausea; and 80% none to mildly
severe vomiting. Only 20% reported severe impairment of overall function, and only 40% severely
impaired QOL. No toxic effects were attributed by patients to the LCS101 treatment, and 85% reported
that they believed the botanical compound had helped reduce symptoms. The effects of LCS101 on
clinical outcomes in breast cancer should be tested further using randomized controlled trials.
Integrative Medicine Insights 2013:8 1–8
https://journals.sagepub.com/doi/full/10.4137/IMI.S10841

6. Medical Research Ltd.
Selective anticancer effects and protection from
chemotherapy by the botanical compound LCS101:
Implications for cancer treatment
Zoya Cohen 1*, Yair Maimon 1*, Merav Yoeli-Lerner1 ,Peiying Yang2, Noah Samuels2 and Raanan Berger3
1. Tal Center for Integrative Medicine, Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel;
2, Department of General Oncology, The University of Texas M.D. Anderson Cancer Center,
Houston, TX, USA;
3. Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel
*Contributed equally
ABSTRACT
There is a need for new options for reducing the side effects of cancer treatment, without
compromising efficacy, enabling patients to complete treatment regimens. The botanical compound
LCS101 exhibits inhibitory effects on cancer cell growth, and reduces chemotherapy-induced
hematological toxicities. The aim of the present study is to examine the selectivity of the effects of the
compound, alone and in conjunction with conventional chemotherapy agents, on cancer cell
proliferation. The effects of LCS101 were tested on a number of cancer cell lines (breast, MCF7, MDA-
MB-231; colorectal, HCT116; prostate, PC-3, DU-145) and on non-tumorigenic normal human epithelial
cells (breast, MCF10A; prostate, EP#2). Cell viability was analyzed using an XTT assay and observed by
light microscopy. Necrosis and apoptosis were examined using FACS analysis and immunoblotting.
LCS101 selectively induced cell death in breast, colon and prostate cancer cell lines, as measured by
XTT assay. Light microscopy and FACS analysis showed changes indicative of a necrotic process.
LCS101 was also found to induce PARP-1 reduction in breast cancer cells, with no effect on non-
tumorigenic breast epithelial cells. While LCS101 increased cell death in cancer cells exposed to
doxorubicin and 5-FU, it showed a protective effect on non- tumorigenic human epithelial cells from
chemotherapy-induced cell death. A similar selective effect was observed with apoptosis-associated
PARP-1 cleavage.
The findings demonstrate that the anti-proliferative effects exhibited by the botanical compound
LCS101 are selective to cancer cells, and offer protection to non-tumorigenic normal epithelial cells
from chemotherapy agents.
International Journal of Oncology
Received August 10, 2014; Accepted September 25, 2014 DOI: 10.3892/ijo.2014.2711
Pubmed link
http://www.ncbi.nlm.nih.gov/pubmed/25333773
International
Journal of
Oncology

7. Medical Research Ltd.
Effect of the Botanical Compound LCS101 on
Cytotoxicity of Chemotherapy
Zoya Cohen1 , Yair Maimon1 , Noah Samuels1 and Raanan Berger2
1. Tal Center for Integrative Oncology, Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel
2. Department of Oncology, Sheba Medical Center, Tel Hashomer, Israel
ABSTRACT
Many oncology patients report using botanicals while undergoing chemotherapy. There are relatively
few studies on the interactions between “natural” products and chemotherapy agents, with implications
regarding safety and efficacy of the conventional treatment. LCS101 is a botanical formula which has
been shown to reduce the incidence of severe anemia and neutropenia, as well adverse events resulting
from chemotherapy regimens for breast cancer.
The formula has also been shown to increase the anti-cancer effects of doxorubicin and fluorouracil (5-
FU) on breast cancer cell lines, while protecting non-tumorigenic breast cells from cell death. The
present study set out to further examine the effects of LCS101 on chemotherapy, this time with
gemcitabine, cisplatin, paclitaxel and etoposide.
For this purpose, lung (A549), breast (MCF7), pancreatic (PANC-1) and bladder (T24) cancer cell lines
were exposed to incremental concentrations of each of the four chemotherapy agents, with and without
the addition of fixed dose of LCS101.
A sulforhodamine B (SRB) assay was used to assess cell viability. The addition of the botanical formula
was found to significantly augment the cytotoxic effects of each of the chemotherapy agents, this in all
four cancer cell lines.
Conclusion :
These findings further support those of previous research on potential interactions between LCS101
with chemotherapy. Additional research is underway to examine the implications of this and other
botanical formulas as an adjunct to conventional oncology treatments.
Journal of Cancer Science & Therapy 2018, 10:9
Link: https://www.hilarispublisher.com/open-access/effect-of-the-botanical-compound-lcs101-on-
cytotoxicity-of-chemotherapy-1948-5956-1000553.pdf

8. Medical Research Ltd.
Botanical Formula LCS101: A Multi-Targeted Approach to
Cancer Care
Yair Maimon1 , Noah Samuels1 , Zoya Cohen1 ,Raanan Berger1 , David S. Rosenthal 2
1. Sheba Medical Center, Tel Hashomer, Israel
2. Harvard Medical School, Boston, MA, USA
ABSTRACT
Background and Purpose:
LCS101 is a botanical formula extracted from 14 botanical components. While conventional oncology
focuses on targeted medicine, research on LCS101 adopts a multi-targeted approach, examining its
preclinical (in vitro, in vivo, and ex vivo) and clinical (randomized controlled trial, pragmatic) effects.
This includes examining the formula’s impact on the immune system, selective anticancer effects, and
improved chemotherapy-related symptoms and quality of life.
Effects on the Immune System:
In murine splenic cell cultures, LCS101 significantly increased T-cell proliferation and macrophage
tumor necrosis factor-α production. Blood samples from healthy volunteers exposed to LCS101 showed
a dose-dependent increase in natural killer cell activity; and a randomized controlled trial showed
significantly lower rates of leucopenia/neutropenia and anemia in patients with breast cancer
undergoing chemotherapy.
Selective Anticancer Effects: In vitro LCS101 demonstrated selective growth inhibition (on XTT viability
assay) in human breast and prostate cancer cell lines, without any harmful effects on normal human
epithelial cells. The anticancer effects were attributed to reactive oxygen species activity. Cytotoxic
effects of doxorubicin and 5- fluorouracil on breast cancer cell lines were significantly increased
following exposure to LCS101, with a protective effect in normal cells.
Symptom Relief and Quality of Life:
Clinical research shows that patients taking LCS101 during chemotherapy are less likely to report
symptoms such as fatigue, pain, nausea and vomiting.
Conclusion: LCS101 exhibits multi-targeted effects, with significant implications for cancer care.
Further research is needed to better understand the impact of these findings.
Integrative Cancer Therapy (Sage publication)
http://journals.sagepub.com/doi/full/10.1177/1534735418801528

9. Medical Research Ltd.
Effect of the botanical formula LCS101 on the anti-cancer
effects of radiation therapy
Zoya Cohen1 · Noah Samuels1 · Yair Maimon1 · Raanan Berger2
1. Tal Center for Integrative Oncology, Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel
2. Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel
ABSTRACT
Background and purpose
The botanical formula LCS101 has been shown in clinical research to reduce chemotherapy- induced
toxicities. In pre-clinical research, the formula demonstrated selective anti-cancer effects, in part as a
result of radical oxygen species (ROS) activity of the botanical components. The present study
examined the interaction between LCS101 and radiation therapy on cancer cell lines.
Methods
Incremental doses of LCS101 were added to breast adenocarcinoma (MCF7), prostate (DU145),
transitional cell bladder carcinoma (T24), pancreatic epithelioid carcinoma (PANC-1), and
osteosarcoma (U20S) cell lines 4 h after single- dose irradiation (range 0.5–4 Gy). Cell viability was
tested using sulforhodamine B (SRB) assay after 1 week, with ROS activ- ity examined using 1 mM of
the ROS scavenger sodium pyruvate (ROS scavenger), testing cell viability with an SRB assay.
Results
The addition of LCS101 to MCF7 (breast) and DU-145 (prostate) cancer cell lines resulted in a dose-
dependent increase in the antiproliferative effects of radiation treatment. The addition of pyruvate
inhibited radiation-induced cell death in all of the cell lines treated with LCS101.
Conclusions
The addition of the botanical formula LCS101 to irradiated cancer cells results in an apparent additive
effect, most likely through a ROS-mediated mechanism. These findings support the use of LCS101 by
patients undergoing radiation therapy, for both its clinical as well as anti-cancer effects.
Journal of Cancer Research and Clinical Oncology
https://link.springer.com/article/10.1007/s00432-018-2812-
4?fbclid=IwAR3O7Sft1WFlGwfkFQ7oSYzfjxviMgUdYMvHa7I32D9SzMVo2Ao6zkcE54g