User talk:Tylerstattin

JBNI Biodrux Naturaceuticals and Geneomics
JBNI is a firm based in Seattle Washington. According to JBNI's web site,

" In 1974, the scientists of JBNI (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, JBNI (then OMR) scientists further succeeded in formulating over 50 natural formulas.

In 1989, JBNI (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

In 1991, JBNI (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 JBNI’s formulas were created to adhere to a safety standard far exceeding any existing regulations. As a result, JBNI’s 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 JBNI and TSRA scientists strived to set new industrial standards, they 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 JBNI scientists.

In 1993, JBNI (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, JBNI (then JJI) scientists have intensified their research in the fields of genomics, genetics, DNA, and proteomics. Together with IDD, CTRC, Beckman, Cyphergen, Luminex, Millipore, and Panomics, JBNI scientists have succeeded in identifying specific biomarkers used to forecast many types of cancer even decades before onset. JBNI 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, JBNI'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, JBNI plans to apply for drug approval for each of its products.

In 2007, following three decades of careful observation, JBNI has made a select group of its products available to the public. These products are sold as nutritional supplements.

In July 2005, the scientific and pharmaceutical community recognized JBNI’s 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 JBNI, 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.

Herbal medicines are considered health food in many Western nations. This perception is due to the slow action and low efficacy of herbal medicine.

JBNI scientists have formulated fast acting, safe, all-natural, herbal remedies that are as effective as commercial pharmaceutical drugs. JBNI scientists have been developing naturaceuticals for decades.

In 1974, the scientists of JBNI (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, JBNI (then OMR) scientists further succeeded in formulating over 50 natural formulas.

In 1989, JBNI (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

In 1991, JBNI (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 JBNI’s formulas were created to adhere to a safety standard far exceeding any existing regulations. As a result, JBNI’s 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 JBNI and TSRA scientists strived to set new industrial standards, they 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 JBNI scientists.

In 1993, JBNI (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, JBNI (then JJI) scientists have intensified their research in the fields of genomics, genetics, DNA, and proteomics. Together with IDD, CTRC, Beckman, Cyphergen, Luminex, Millipore, and Panomics, JBNI scientists have succeeded in identifying specific biomarkers used to forecast many types of cancer even decades before onset. JBNI 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, JBNI'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, JBNI plans to apply for drug approval for each of its products.

In 2007, following three decades of careful observation, JBNI has made a select group of its products available to the public. These products are sold as nutritional supplements.

28 September - 1 October 2004, Geneva, Switzerland

Abstracts

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

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.

Identification of Serum Biomarkers for Lung Cancer Added 09/18/08 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."