Company
Portfolio Data
Back to Company SearchWELLGEN, INC.
Address
675 US Highway OneNorth Brunswick, NJ, 08902-
USA
UEI: N/A
Number of Employees: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2002
2
Phase I Awards
0
Phase II Awards
N/A
Conversion Rate
$418,586
Phase I Dollars
$0
Phase II Dollars
$418,586
Total Awarded
Awards
Administrative supplement to 5R44DA025375-03: Prescription drug abuse prevention
Amount: $293,244 Topic: NCCAM
DESCRIPTION (provided by applicant): Type 2 Diabetes (T2D) is an inflammatory disease affecting 26 million people in the US (11%) and is predicted to affect more than 30% of adults in the US by 2050. The economic cost of T2D is over 200 billion a year. People with T2D suffer from hyperglycemia due to low insulin production, poor transport of insulin, or cellular resistance to insulin which can lead to retinopathy, nephropathy, neuropathy, and cardiovascular disease. Chronic inflammation in T2D is a leading cause of the progression of the disease. Obesity, also occurring at epidemic rates in the US, causes chronic low- grade inflammation thus contributing to T2D. Although current therapies can maintain glucose control and reduce insulin resistance, complications associated with chronic inflammation and organ damage drive the effort to develop drugs targeting specific steps in the inflammatory cascade. We propose that natural products have the potential to fill this therapeutic gap while reducing potential side effects and compensatory reactions requiring secondary treatment. To combat the inflammation that leads to T2D and its complications, we developed two naturally derived products: WG0401 and WG0301, which are both proprietary, novel, well-characterized,bioactive enhanced natural extracts. Both extracts show strong effects against inflammation as demonstrated in human cell-based bioassays and animal models of inflammation. Both were well tolerated in humans in previously conducted clinical trials and canbe Generally Regarded As Safe (GRAS), thereby reducing the time and expense of getting a product to market. Our goal is to develop a novel, effective medical food to control the underlying pathological effects of chronic inflammation that lead to T2D. Aim1. Demonstrate that WG0401 and WG0301 will reduce inflammatory metabolites that lead to complications of T2D. Biomarkers for T2D and inflammatory metabolites that play major roles in T2D will be measured in the Zucker diabetic fatty rat animal model of T2D that have been treated with WG0401 or WG0301. Successful results will show statistically significant improvement within treatment groups or between controls and treated rats. Aim 2. We propose that the inhibition of inflammatory genes reduces the metabolites measured in Aim 1. We will measure correlations between the gene products and the down-regulation of inflammatory metabolites and/or biomarkers for inflammation and T2D by WG0401 and WG0301 and compare to metformin and ibuprofen. Observation of a positive correlation supports our hypothesis. Aim 3. Select one of the two products based on the results above for further development. Successful completion of this project will enable the design and initiation of clinical trials in Phase II, using one of our extracts for the management of T2D. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Patients afflicted with Type 2 diabetes (T2D) suffer from chronic inflammation that leads to well-known and potentially devastating complications. The proposed project will determine the efficacy of two, proprietary WellGen GRAS certified natural extracts in the reduction of inflammation associated with T2D in a rat model. The goal of the proposed project is a novel and effective ingredient in a medical foodproduct for the management of T2D and its complications in the rapidly increasing number of T2D patients.
Tagged as:
SBIR
Phase I
2013
HHS
NIH
PRECLINICAL EVALUATION OF BLACK TEA EXTRACTS
Amount: $125,342
DESCRIPTION (provided by applicant): Many claims suggesting health beneficial effects of black tea and its components exist in the scientific and lay literature. One such presumed health benefit of tea consumption is decreased risk of cancer. In the United States, each year there are 93,800 new cases and 47,700 deaths due to colon cancer. Among cancer diseases, the evidence for the importance of diet and nutrition is strongest for colon cancer. Therefore, there is a need to find ways to prevent this disease. The overall goal of WellGen, Inc. is to find and develop value-added dietary supplements using sound scientific information. This proposal, entitled "Preclinical Evaluation of Black Tea Extracts" is consistent with our primary goal. Scientific information will be generated in model systems before evaluation in humans. Based on this knowledge, black tea dietary supplements will be developed. Black tea extracts, theaflavin mixtures derived from green tea, and purified chemicals that occur in black tea will be evaluated in three mouse models. All compounds will be evaluated in two mouse ear inflammation assays. Selected compounds will be evaluated in a Min mouse model for colon cancer. The following specific aims are designed to accomplish the overall goal for the 6 months of the Phase 1 study. 1. Prepare standardized, modified theaflavin extracts from decaffeinated green tea 2. Prepare from catechin precursors the following pure compounds: theatlavin(TF-1), theaflavin-3-monogallate and theaflavin-3'-monogallate ( the combination of these two isomers are referred to as TF-2), and theaflavin-3,3'-digallate (TF-3) (200 mg each to evaluate in mouse ear models) 3. Evaluate decaffeinated black tea extract, theaflavin extracts and four pure theaflavin compounds in the 12-O-tetradecanoylphorbol-13 acetate (TPA) and arachidonic acid (AA) induced mouse ear models. 4. Evaluate decaffeinated black tea extract and theaflavin extracts in a Min mouse model 5. Conceptualize and analyze prototype product (dietary supplement) development strategy 6. Plan for biomarker endpoint colon cancer clinical studies
Tagged as:
SBIR
Phase I
2002
HHS
NIH