UNITED STATES PATENT, 2007.
September, 2022
UNITED STATES PATENT, 2007.
After rigorous analysis and verification, the United States Patent and Trademark Office granted BIRM patent No. US 7,250,180 B2, which recognizes the product’s originality and authorizes its medicinal use in the prevention and cure of various diseases. This certificate guarantees BIRM’s quality and protects it from any attempts at counterfeiting.
BIRM MEDICAL SCIENTIFIC MAGAZINE 3
ANTITUMOR AND CHEMOPREVENTIVE ACTIVITY OF THE ECUADORIAN PLANT EXTRACT BIRM, 2007.
Lokeshwar, Bal L. University of Miami School of Medicine, Coral Gables, FL, United StatesPatients with malignant diseases commonly consume poorly characterized medicine or dietary supplements. Extensive use of untested formulations, provide both opportunities and danger. BIRM, an Ecuadorian oral solution, is a dietary supplement developed from the Andean variety of Solanum dulcamara L, which is widely consumed in the Americas for a variety of diseases, including prostate and breast cancers, without any noted toxicity. Initial laboratory studies of BIRM on prostate cancer models showed strong cytotoxic antitumor activity, including induction of apoptosis, cell-cycle arrest, reduction in androgen receptor levels and down-regulation of pro-survival genes. Oral dosing of BIRM in a rat Dunning MAT LyLu model and in human prostate cancer xenografts showed chemopreventive and antimetastatic activities of BIRM. It decreased tumor incidence (75%), tumor growth (50%) and metastasis (63%). These observations provide the basis for further investigation into the use of BIRM as a chemopreventive dietary supplement. The main hypothesis, to be tested in this project, is that BIRM is a non-toxic, chemopreventive, natural product with the potential to retard tumor growth, progression and recurrence. The main objective of this application is to establish the chemopreventive and antimetastatic activity of BIRM in transgenic models of prostate cancer with the goal of establishing its safety and efficacy for use in controlled clinical trials.
In Aim 1, the minimum effective dose, optimum effective dose and maximum tolerated dose of BIRM will be established in the TRAMP (transgenic adenocarcinoma of the mouse prostate) model. In addition, the chemopreventive and antitumor activities of BIRM will be investigated using two distinct transgenic models that develop prostate tumor by either an androgen-independent (GvT-15 model) mechanism or by the conditional knock-out of a tumor suppressor gene (PTEN) in the prostate (PTEN loxp/loxpPBCre-4).
In Aim 2, the molecular mechanism of BIRM induced apoptosis, cell cycle arrest and androgen receptor degradation will be investigated by delineating the alterations in the molecular signatures of respective signaling pathways.
In Aim 3, the efficacy of BIRM either alone, or in combination with standard chemotherapy, will be evaluated for preventing the emergence of hormone-refractory prostate cancer in two human prostate cancer orthotopic xenograft models, LNCaP and LAPC-4, which demonstrate distinct molecular forms of androgen receptor. Relevance: This study will establish safety and toxicity profiles of BIRM and determine whether BIRM, a complex natural product, has 1. a proven chemopreventive efficacy against prostate cancer and 2. if the efficacy of proven cancer therapies are enhanced or significantly compromised by BIRM. This study should also provide a rationale for further development (if any), of this chemopreventive agent, i.e., clinical trials for prostate cancer and other malignant cancers.
MEDICAL SCIENTIFIC MAGAZINE 4 BIRM ANTITUMOR
ECUADORIAN
Pg. 1
AND CHEMOPREVENTIVE ACTIVITY OF THE
PLANT EXTRACT BIRM
National Institute of Health (NIH) National Center for Complementary & Alternative Medicine (NCCAM) Research Project (R01)
1R01AT003544-01A1
7197505
Chemo/Dietary Prevention Study Section (CDP) Sorkin, Barbara C
ANTITUMOR AND CHEMOPREVENTIVE ACTIVITY OF THE ECUADORIAN PLANT EXTRACT BIRM
BIRM MEDICAL SCIENTIFIC MAGAZINE 5
Pg. 2 Agency Institute Type Project # Application # Study Section Program Officer Project Start Project End Budget Start Budget End Support Year Fiscal Year Total Cost Indirect Cost Name Department Type DUNS # City State Country Zip Code
2011-07-31 2007-08-01 2008-07-31 1 2007
of
School of Medicine Urology Schools of Medicine 052780918 Coral Gables FL United States 33146 Institution Funding Agency
2007-08-01
$302,940 University
Miami
Related projects
NIH 2010 R01 AT
Antitumor and chemopreventive activity of the Ecuadorian plant extract BIRM
Lokeshwar, Bal L. / University of Miami School of Medicine
$293,913
NIH 2009 R01 AT
Antitumor and chemopreventive activity of the Ecuadorian plant extract BIRM
Lokeshwar, Bal L. / University of Miami School of Medicine
$296,881
NIH 2008 R01 AT
Antitumor and chemopreventive activity of the Ecuadorian plant extract BIRM
Lokeshwar, Bal L. / University of Miami School of Medicine
$296,881
NIH 2007 R01 AT
Antitumor and chemopreventive activity of the Ecuadorian plant extract BIRM
Lokeshwar, Bal L. / University of Miami School of Medicine
$302,940
MEDICAL SCIENTIFIC MAGAZINE 6 BIRM
ANTITUMOR AND CHEMOPREVENTIVE ACTIVITY OF THE ECUADORIAN PLANT EXTRACT BIRM Pg. 3
Publications
Shamaladevi, Nagarajarao; Araki, Shinako; Lyn, Dominic A et al. (2016) The andean anticancer herbal product BIRM causes destabilization of androgen receptor and induces caspase-8 mediated-apoptosis in prostate cancer.
Oncotarget 7:84201-84213
Salazar, Nicole; Castellan, Miguel; Shirodkar, Samir S et al. (2013) Chemokines and chemokine receptors as promoters of prostate cancer growth and progression.
Crit Rev Eukaryot Gene Expr 23:77-91
Shamaladevi, Nagarajarao; Lyn, Dominic A; Shaaban, Khaled A et al. (2013) Ericifolin: a novel antitumor compound from allspice that silences androgen receptor in prostate cancer.
Carcinogenesis 34:1822-32
Zhang, Lei; Lokeshwar, Bal L (2012)
Medicinal properties of the Jamaican pepper plant Pimenta dioica and Allspice.
Curr Drug Targets 13:1900-6
Singh, Rajendra Kumar; Lokeshwar, Bal L (2011)
The IL-8-regulated chemokine receptor CXCR7 stimulates EGFR signaling to promote prostate cancer growth.
Cancer Res 71:3268-77
Lokeshwar, Bal L (2011) Chemically modified non-antimicrobial tetracyclines are multifunctional drugs against advanced cancers. Pharmacol Res 63:146-50
Shamaladevi, Nagarajarao; Lyn, Dominic A; Escudero, Diogo O et al. (2009) CXC receptor-1 silencing inhibits androgen-independent prostate cancer.
Cancer Res 69:8265-74
Singh, Rajendra K; Lokeshwar, Bal L (2009) Depletion of intrinsic expression of Interleukin-8 in prostate cancer cells causes cell cycle arrest, spontaneous apoptosis and increases the efficacy of chemotherapeutic drugs.
Mol Cancer 8:57
BIRM MEDICAL SCIENTIFIC MAGAZINE 7
4
ANTITUMOR AND CHEMOPREVENTIVE ACTIVITY OF THE ECUADORIAN PLANT EXTRACT BIRM Pg.
During more than 45 years, BIRM has been the most tested and studied immunomodulator. Laboratories and Universities around the world, have examined its healing properties with incredible results:
VISIT US: www.birm.com
CONTACT US IN ECUADOR: consultas@birm.com.ec
CONTACT US IN COLOMBIA: ventasbirmcolombia@greenterra.com.co www.birm.com.co
CONTACT US IN THE UNITED STATES: info@birmproducts.com www.birmproducts.com
CONTACT US IN SPAIN: ventas@greenmedilab.com
CONTACT US IN PERU: pfranco@grupofs.com
Quito - Ecuador
Manuel Iturrey N2805 y Bello Horizonte
Edificio Artes, 2005, Piso 2
PBX: (+593) 2 2992910 / Tel.: (+593) 2 2509861 / (+593) 2 2562995 / (+593) 2 2563918 Fax: (+593) 2 2564374
Bogota - Colombia
GREEN TERRA LIFE S.A.S
Carrera 11 No. 86-32 Tel: (+57) 3182854042
Morgan Hill - U. S. A. 17100 Monterey Rd., Suite 1A, Ca 95037 Tel.: +1 (669) 888-3005
Santiago del Surco - Peru
Av. del Pinar 110 oficina 405 Tel.: (+51) 939 343 332
FOLLOW US:
SCAN THE CODE FOR MORE INFORMATION
