The Product

BACKGROUND

The ingredients included in the formulation for Prebiox Plus evolved from product development activities commencing in 2001. Two formulations were successfully completed but not commercialized. The first formulation MFOS Plus was a tropical fruit flavored powder for solution containing the following medicinal ingredients per individual sachet: short chain fructooligosaccharides or scFOS (1.0 gm), Lactobacillus acidophilus (1 billion/cfu), Bifidobacterium longum (0.5 billion/cfu) and Bifidobacterium bifidum (0.5 billion/cfu). Proposed market emphasis for the product was an intestinal support formula for all ages. The recommended use was “Taken daily, helps to restore a healthy balance of friendly bacteria in the intestinal tract”. Prototype packaging by our company Canacure Corporation at the time was to have 30 sachets per carton (see image below). MFOS PLUS

The second formulation under the code names Colonaid and Prebiox was a cranberry flavored oral liquid each tablespoonful or 15 mL containing the medicinal ingredients scFOS (3.0 grams), epigallocatechin 3-gallate or EGCG (30 mg) and ascorbic acid (75 mg). This formulation received a product license (NPN 80010202) from the Natural Health Products Directorate of Health Canada on May 20 2009. The recommended use was “Increases the numbers of bifidobacteria in the intestinal tract and provides antioxidants for the maintenance of good health”. A patent application was filed with the US Patent Office ((US 2009/0022852) and the entire intellectual property belonging to this formulation was eventually acquired by a US dietary supplement company. The company ultimately decided not to proceed with the formulation and eventually transferred the IP back to our group. Unfortunately the patent was abandoned because the US firm had neglected to follow up on requests from US Patent personnel. This liquid product would be an excellent adjunct product to Prebiox Plus to serve as bowel regularity therapy and maintenance, especially in senior citizen homes. The latter product and its IP could be included in an acquisition package along with Prebiox Plus if a party is interested.

prebiox

EGCG INCLUSION RATIONALE

The two principle R&D personnel involved with the company are both senior citizens and can both attest to the fact that the dietary fibers used in Prebiox Plus have been ingested daily by them for years and that their effects were capable of consistently maintaining bowel regularity during this time. Introduction of the tea catechin (-)-epigallocatechin-3-gallate (EGCG) at 300 mg into the formula occurred at a time when one of the personnel (DLS) found his PSA levels increasing at a rather rapid rate during a 20-month interval (3.65 to 5.19 ng/mL). A medical literature review revealed an interesting study demonstrating the potential of green tea catechins (GTC) in helping to prevent prostate cancer. In this double-blind placebo-controlled study[1], sixty (60) volunteers presenting with high-grade prostate intraepithelial neoplasia lesions (HG-PIN) were randomly assigned so that 30 ingested daily either green tea catechins (600mg – ~320mg EGCG) and the remaining 30 a corresponding placebo. The primary end point was prevalence of prostate cancer during the 1-year study in the two arms. Biopsy results after one year showed that only one cancer was diagnosed among the 30 men receiving GTC daily (3% incidence) versus nine cancers in the 30 men that received placebo (30% incidence). In the placebo arm six cancers were found after 6 months and 3 more at 12 months. The GTC-arm provided only one cancer at 12 months leading the authors to suggest 90% chemoprevention efficacy of GTCs in men subjected to a high risk of prostate cancer. Statistical analysis showed results to be highly significant. Serum PSA levels demonstrated that a trend toward a more stable total PSA value was clearly evident in the GTC-treated men. The same authors performed a follow-up in a subset of these patients after two years [2]. Despite similar drop-out rates, the two arms remained balanced and large enough for statistical analyses and the results achieved after one year of GTC administration proved to be long lasting. Overall the GTC treatment led to an almost 80% reduction in prostate cancer diagnosis.

N.B.    The author of this summary (DLS) can report that the addition of 300mg EGCG to the daily fiber regimen (Prebiox Plus) starting after the 20 month interval cited above brought a halt to PSA increases. Yearly follow-ups (image below) have revealed relatively constant levels presenting for the past 4 years and maintained below expected levels (< 6.5 ng/mL) for a person of his age.

PSA LEVELS

A proposed prototype of sachet labelling for the product is presented in the image below.

PP POUCH LABEL 3

[1] Bertuzzi S et al (2006) Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Research 66(2):1234-1240.

[2] Bertuzzi S et al (2008) Chemoprevention of human prostate cancer by green tea catechins: two years later. A follow-up update. European Urology (Letter to the Editor) 54:472-473.

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