History & Science
"Biodrux has worked for decades to research, develop, and test its formulas"
Herbal medicines are considered health food in many Western nations. This perception is due to the slow action and low efficacy of herbal medicine. Biodrux scientists have formulated fast acting, safe and toxin-free all-natural, herbal remedies that are as effective as commercial pharmaceutical drugs. Biodrux scientists have been developing naturaceuticals for decades.
In 1974, the scientists of Biodrux (then DHI) succeeded in developing all natural NSAID's (Non-Steroidal Anti-Inflammatory Drugs). While developing non-anaphylactic NSAIDs, they additionally succeeded in combining the strong anti-inflammatory function with antibacterial, antiviral, antifungal qualities. As a result, the natural Formula 15.1 became the first antibiotic that also eliminated fungal growth as well as inflammations.
In 1978, Biodrux (then OMR) scientists further succeeded in formulating over 50 natural formulas.
In 1989, Biodrux (then JJHC) succeeded in further improving Formula 15.1 by strengthening its anti-inflammatory action and pain killing capabilities. This improvement marked the new Formula 15.3 (Bioprin)
In 1991, Biodrux (then JJI) scientists collaborated with TSRA (Triple S Research Associates) in order to further improve the overall safety and efficacy of its formulas. All of Biodrux's formulas were created to adhere to a safety standard far exceeding any existing regulations. As a result, Biodrux herbal formulas yielding zero side effects with a single dose at 1/500 -1/100 of body weight. Many formulas were also tested against metastatic breast cancer (closely related to lung cancer), colorectal cancer, and skin cancer.
While Biodrux and TSRA scientists strived to set new industrial standards, we discovered that the FDA had not yet set any requirements limiting heavy metal concentrations in food products. FDA scientists have since developed new standards on heavy metal, herbicide, and pesticide content based in part due to data from TSRA and Biodrux scientists.
In 1993, Biodrux (then JJI) began distributing nutritional health supplements exclusively to licensed physicians in the USA, which included MDs, DOs, LAcs and DCs. This decision was implemented as part of a long-term clinical observation strategy.
Since 2001, Biodrux (then JJI) scientists have intensified the research in the fields of genomics, genetics, DNA, and proteomics. Together with IDD, CTRC, Beckman, Cyphergen, Luminex, Millipore, and Panomics, Biodrux scientists have succeeded in identifying specific biomarkers used to forecast many types of cancer even decades before onset. Biodrux scientists, together with IDD, CTRC, and CPC, have since led their peers in cancer prevention studies ever since. Abstracts documenting their collaboration are featured annually in AACR, NIH, NCI, and EORTC conventions.
In 2004, Biodrux's "Azmazin" received an IND (Investigational New Drug) number from the FDA as an asthma drug. It is anticipated to become the first natural drug, for asthma, approved by the FDA. Once completed, Biodrux plans to apply for drug approval for each of its products.
In 2007, following three decades of careful observation, Biodrux has made a select group of its products available to the public. These products are sold as nutritional supplements
In 2012, Biodrux proudly becomes a naturaceutical division of Symbiogene with its headquarters in Michigan City, Indiana USA
Biodrux products have been through stringent analysis to ensure the highest standard of safety. Biodrux developed research methods that exceed those required by FDA standards. The results are sound and reliable.
In 1993, Biodrux contracted Triple S Research Associates (TSRA) to conduct safety and anti-tumor testing. Our view has been to establish the credibility of natural products, which can only be supported by verifiable clinical evidence.
The contributing research organizations, for the Biodrux products, include the Cancer Therapy and Research Center (CTRC)/The Institute for Drug Development (IDD), The Dana-Farber Cancer Institute, The University of New England Medical School, as well as TSRA. The following are scientists and researchers who have provided additional expertise:
- Dr. Beverly Teicher, Ph.D - Senior Scientific Director in Cancer Research at Genzyme Molecular Oncology and Genzyme Corporation
- Dr. Arthur Pardee Ph.D - Professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School
- Dr. Marianne Spada, Ph.D. - recipient of a SBIR grant from the National Cancer Institute (NIH) on the development of novel anti-tumor agents for breast cancer
- Dr. Georgia Sotiropoulou, Ph.D. - Advanced Center for Detection of Cancer, Ontario, Canada. Associate Professor Department of Pharmacy/The School of Health Sciences at the University of Patras, Greece
- Dr. John Cheng, Ph.D. - Expert in the isolation, identification and structural elucidation of natural products
Founding Research: Building a Better Model
The standard test required by the FDA is called Lethal Dose 50 (LD-50). It's an archaic model that has been used since its invention in 1927 to test chemical ccity in one dose. Lethal Dose 50 means that 50% of the test subjects must die in one dose. Biodrux products possess no toxicity and could not be effectively tested in this manner. No matter how much Biodrux product was given a test subject, no toxicity at all could be observed.
To satisfy the FDA standard and to design a scientifically sound test, a new model was needed. The resulting protocol, designed by the TSRA scientists, both scientifically satisfies and supersedes the FDA's LD-50 standards.
Biodrux's products were tested by TSRA at The Dana-Farber Cancer Institute. The tests were designed specifically by Dr. Beverly Teicher and Dr. Marianne Spada. The model created, is explained under Safety & Toxicity, signals the presence of any toxicity and also shows the anti-tumor activity of the product.
Creating absolutely safe products is of the utmost importance at Biodrux. All of the ingredients found in Biodrux products are found on the FDA's Generally Recognized as Safe (GRAS) list. The GRAS list foods are safe for daily consumption.
We measure each formulation to a simple and uncompromising rule: NO SIDE EFFECTS. To demonstrate that our products meet this requirement, each has undergone the following testing protocols:
Anti-tumor Activity: The products have been tested and analyzed for anti-tumor activity. While all of the 20 products have noticeable activity, Leitzin, Bioprin, Cirrin, and Azmazin have shown significant results equivalent to chemical chemotherapeutic agents against metastatic breast cancer.
Toxicity: The products are tested beyond government and industry standards for toxicity. Each product undergoes the Standard Tolerance Level Single Dose Toxicity for Natural Medicinal Compound (STL500-100). STL500-100 requires complete safety at a one-time dose of 1/500th as the minimum and up to 1/100th of a person's weight. Biodrux products were found to be safe at the one-time dose of 1/100th the weight, which is equivalent to a person ingesting a one-time dose of 1.5 to 2 pounds, 750-1000 grams, or 5-25 bottles (containing 60 capsules each) of Biodrux product.
Safety tests are not necessary for ingredients such as garlic. While Biodrux formulas utilize those safe ingredients, which do not require testing, Biodrux follows through with stringent testing of the formulas.
The test method utilized mice implanted with an EMT-6 xenograft and injected with tumor cells. Mice with the injected tumor cells have a higher level of sensitivity and response to toxicity. This testing method allows for minute levels of toxicity to be noted if present.
The herbs used in Biodrux naturaceuticals and the unique fomulations were deemed safe through the rigorous testing.
A Proteomics Victory Over Cancer
In July 2005, the scientific and pharmaceutical community recognized Biodrux research in the battle against cancer. This research material garnished cover page status for the July-August issue of "Cancer Genomics & Proteomics," a journal published by the International Institute of Anticancer Research.
Natural products LP-01 and LP-02, developed by Biodrux, were presented in cooperation with CTRC-The Institute for Drug Development, San Antonio, TX at AACR-NCI-EORTC 2004: September 28-October 1, The AACR-NCI-EORTC held an international conference on molecular targets, cancer therapeutics, and clinical applications in Geneva, Switzerland. The positive results involving our serum proteomic biomarkers used in a randomized, placebo-controlled clinical trial for patients at risk for lung cancer was met with great acclaim.
In November 2003, the AACR-NCI-EORTC held an international conference on molecular targets, cancer therapeutics, and clinical applications in Boston, Massachusetts. There the abstract entitled "Serum Biomarkers of Natural Product Therapy in Human Lung Cancer Xenograft Models" was presented, demonstrating the efficacy of our novel entities (LP-01 and LP-02) in high-risk lung cancer patients.
A Historical Breakthrough in the Treatment of Asthma
Biodrux has received an FDA Investigational New Drug Number for our natural drug intended to treat chronic and debilitating Asthma. This is the first product from a line of all-natural, efficacious therapies used for chronic medical conditions. Results of our research conducted in conjunction with CTRC Institute for Drug Development, San Antonio, TX, were presented in an abstract entitled "Efficacy, short-term safety, and serum biomarkers in a clinical trial of IND#70190" at the San Antonio Cancer Institute by Dr. Elzbieta Izbicka, chief investigator.
16th EORTC-NCI-AACR Symposium on Molecular Targets, Cancer Therapeutics       28 September - 1 October 2004, Geneva, Switzerland
Smoking, asthma, and chronic obstructive pulmonary disease (COPD) are known risk factors for lung cancer. The disease may be preventable, but many potential chemopreventive agents have not shown clinical activity in individuals at risk for lung cancer (Van Zandvijk et al, Lung Cancer 2003, 42:S71). A novel natural product LP01 demonstrated preclinical preventive and anticancer activities, and induced time-and dose-dependent changes in serum kallikreins and proteomic patterns in human lung cancer xenograft models (Baek et al, Proc AACR/NCI/EORTC 2003).
The present study evaluated LP01 in a prospective, randomized, triple-masked, placebo-controlled, parallel-group clinical trial. In this study, lung cancer risk (1-5) was assessed based on length of addiction, asthma, and COPD, for a group of former long-term smokers (smoked > 20 years, quit > 1 year). This group, comprised of sixty men and women ages 35-70, received oral daily doses of 3,650 mg LP01 or placebo for 6 months.
Peripheral blood serum specimens were obtained at the baseline and after drug treatment for 2 weeks, 1 month, 2 months, 4 and 6 months. Serum proteins were resolved on IMAC3/Cu metal affinity ProteinChip arrays and analyzed by surface-enhanced ligand desorption/ionization (SELDI). There were no adverse clinical effects of the therapy.
Abstract 583: Serum proteomic biomarkers of a natural product in a prospective randomized placebo-controlled clinical trial in patients at risk for lung cancer
Citation: European Journal of Cancer Supplements Volume 2, No.8, September 2004, page 177
S. Baek, D. Campos, E. Izbicka, J Jiang
Cancer Therapy and Research Center, The Institute for Drug Development, San Antonio, TX, USA
Identification of Serum Biomarkers for Lung Cancer
Background: Symptoms of lung cancer (LC) often do not appear until the disease is advanced; only 15% of LC cases are discovered while the tumor is in the early stages of development. Carcinogen exposure, asthma and smoking have been determined to be risk factors for the development of LC. Early detection of LC will likely have a major impact on the natural history of the disease, while helping to facilitate a curative treatment. The objective of this study was to apply multiplexed immunoassays to identify a panel of biomarkers for early detection of LC.
Methods: Normal (NO) serum controls (n = 30) from healthy volunteers and lung cancer patients (n = 30) were acquired from a commercial vendor. Baseline (pre-treatment) serum specimens from individuals with asthma (AST; n = 28) and lung cancer risk (LCR; n = 73) were available from clinical trials of two novel agents that are being developed by JBNI Inc. for the respective indications. Serum levels of 59 cytokines, growth factors and biologically active peptides were quantified using multiplexed immunoassays using the Luminex platform to identify biomarkers that are expressed in a significantly different manner in individuals with LC, LCR, or AST in comparison with NO subjects. Data was reduced using nearest neighbor cluster analysis with squared Euclidian distance to separate patients into groups across analytes with inter-pathology comparisons determined using Student's t test.
Results: Multiple analytes showed highly significant differences (p < 0.0002) between LC and healthy controls as single indices of pathologic state. In addition we were able to differentiate AST from LC (p < 0.002) and LCR and LC (p < 0.0001) using a panel of thirteen markers in various combinations. Using multiplexed assays we found significant differences in biomarker levels in sera of LC compared to NO, in NO compared to AST and LC compared to AST samples. Our results support an extended multiplexed immunoassay-based analysis of serum biomarker profiles as supplementary tools for the diagnosis of pathologic and as an aid in the development of novel agents for prevention, early detection and treatment of LC.
Conclusions: We have identified a group of markers having high inter-pathology discrimination power that are capable of reliably differentiating AST and LC from control specimens. This panel remains to be validated in a larger set of specimens but we are confident that these measures will produce clinical assays capable of reliably diagnosing lung pathology.
Novel serum biomarkers for renal cell carcinoma NIH AACR
Background: Renal cell carcinoma (RCC) is often undetected until it has reached an advanced stage. Currently there are no reliable blood biomarkers to monitor the presence of the disease and/or response to therapies. Mass spectrometry (MS) based proteomics provides tools for sensitive and high-throughput screening of proteinaceous biological samples and greatly facilitates biomarker discovery.
Materials and methods: Sera from patients diagnosed with RCC were obtained at the baseline (n=14), then from the same individuals at week 1 (n=10), week 2 (n=5), and week 3 (n=7) after radical nephrectomy. In addition, unrelated RCC (n=4) and healthy control sera (n=30) were collected. Levels of inflammatory cytokines and growth factors (interleukins 1ÃŸ, IL 2-7, 10, 12, and 13, GM-CSF, interferon-, TNF-α) were quantified in multiplex immunoassays. SELDI TOF MS protein profiling of the whole sera and specimens immunoprecipitated with anti-kallikrein antibodies was done in IMAC-Cu arrays. Further purification and identification of differentially expressed proteins were obtained through a combination of two-dimensional gel electrophoresis (2DPAGE), in-gel trypsin digestion and LC-ESIMS for peptide fingerprinting. LC-ESIMS/MS was then used for de novo peptide sequence analysis. Mass spectral data was reduced using the Mascot database search engine. Initial matches were refined and confirmed using raw data, then compared against decoy databases to reinforce identifications. Data was further refined using Progenesis Stats.
Results: Serum levels of all growth factors and cytokines (except IL-6) increased, with significance (p < 0.05), above the baseline until 3 weeks post-nephrectomy.
Conclusions: SAA, an inflammatory acute phase protein, has been viewed as a biomarker of host response in many human cancers. The recently reported presence of SAA in tumor tissue suggests an alternative function of the protein. Sudden disappearance of SAA versus persistent upregulation of multiple inflammatory proteins in post-nephrectomy RCC sera supports this notion. The additional matches derived from the 2D gels of the immunoprecipitates are all either reasonably expected or supported by recent literature identifications in other pathologies. The identifications of the other targets are being confirmed by independent methods. Selective proteome isolation by targeted Mass spectrometry is a promising analytical tool with potential clinical applications.
Proteomic Biomarkers In Drug Development
Biomarker (noun): Biomarkers are cellular, biochemical, or molecular alterations that are measurable in biological media such as human tissues, cells, or fluids. They indicate the presence of biological events or concerted events that are directly associated with a particular disease state.
Molecular Biomarkers (noun): Molecular biomarkers include proteins, carbohydrates, nucleic acids, and other compounds that provide insight into an individual's health for screening risk factors, diagnosis, and prognosis. Molecular biomarkers are also extremely useful for drug discovery purposes.
Clinical Needs, Patient Perspective: Am I at risk for cancer? Is there anything I can do to alter the risk?
Method of Identifying Proteins in Human Serum Indicative of Pathologies of Human Lung Tissue
Method of Identifying Biomarkers in Human Serum Indicative of Pathologies of Human Lung Tissue
Dr. Sung Baek (aka Grand Master Sung Baek) along with his counterparts Dr. Robert Streeper and Dr. Elzbieta Izbicka, all of which are members of the Cancer Therapy and Research Center CTRC and The Institute for Drug Development IDD, have filed a patent that covers various methods of detection, identification, assessment, prevention, diagnosis, and treatment of lung disease, such as non-small cell cancer or reactive airway disease, using biomarkers and kits thereof. By comparing the biomarkers associated with the respiratory system pathologies to the biomarkers of a normal person's serum, it is possible to detect the presence of the pathologies.
Currently, it is the presence or absence of a tumor that is noted and used in the diagnosis of lung cancer. Lung cancer is generally very hard to diagnose in its early stages. The difficulty to diagnose early plays a major factor in lung cancer patients' low survival rates.
Reactive airway diseases, such as asthma and chronic obstructive pulmonary disease, is also diagnosed typically after a presentation of symptoms. After the symptoms arise the current methods to detect asthma are restricted to either function tests or challenge tests. A multitude of other test are often utilized to rule out other pathologies.
Dr. Sung Baek, Dr. Robert Streeper, and Dr. Elzbieta Izbicka, have identified a number of biomarkers which are useful in detecting lung diseases, such as non-small cell lung cancer or reactive airway disease. Their invention provides various diagnostic, prognostic and therapeutic methods, which depend on the identification of these biomarkers.
In Association with the IDD (Institute for Drug Development), Dr. Baek and his CPC (Cancer Prevention and Cure) team have also been honored to present their ongoing findings at the EORTC (European Organisation for Research and Treatment of Cancer) and AACR (American Association for Cancer Research) Annual Conferences.