AGEprost, developed using the extract of a herb called Ageratum conyzoides, recently received GRAS (Generally Recognised as Safe) status after a series of tests and clinical trials to affirm its safety and efficacy for human consumption.
Old ingredients, new uses
Speaking to NutraIngredients-Asia about the AGEprost's origin, Gencor MD RV Venkatesh said: "In the prostate health segment, there has been a lack of new products over the years. The market has been running only on saw palmetto, pumpkin seed, stinging nettle, and Pygeum.
"Saw palmetto has had supply issues, and Pygeum is an endangered species that's been almost run out of the market. There are also no strong clinical studies on pumpkin seed or stinging nettle, outside of their traditional usage."
With this in mind, Gencor began to consider exploring a potential solution with a new product in this segment. The company started researching A. conyzoides, which has traditionally been used in the Caribbean, Africa and parts of South America.
After obtaining an extract from the herb and screening it for toxins and prostate health potential, the firm found it was an effective inhibitor of 5α-reductase, an enzyme involved in androgen metabolism, as well as the reduction progesterone in androgen-stimulated prostate cell lines.
Trial and toxicology
This encouraged Gencor to go on to conduct animal and human studies. In its animal study, published in Regulatory Toxicology and Pharmacology, the ethanolic extract of A. conyzoides was found to be non-mutagenic and non-genotoxic in rats.
Researchers from the Queensland University of Technology and University of Sydney then conducted a double-blind, placebo-controlled clinical study involving 109 otherwise healthy men aged 41 to 76 years, who had medically diagnosed benign prostatic hypertrophy (BPH).
After 12 weeks of supplementation with 250mg of AGEprost daily, the participants in the intervention group showed "excellent response in all areas linked to prostate health", including a statistically significant reduction in their total International Prostate Symptom Score (IPSS), which is considered the gold standard in tools for assessing prostate health.
The researchers also observed a statistically significant reduction in the frequency of daytime and nighttime urination in the supplemented group.
Venkatesh said: "The results were far superior to what we had seen from studies on saw palmetto. In the last 15 to 16 years, a lot of the studies on saw palmetto have shown it has little significant effect compared to placebo.
"The paper was also peer reviewed and published in BioFactors, which is a 5.5 Impact Factor journal. Normally, nutraceutical studies are unlikely to be published in journals with an Impact Factor of 5 or above, but this shows we managed to develop the extract into something new with lasting effects."
Additionally, Gencor conducted a range of human toxicity studies required for GRAS, Novel Food status and other approvals, and the results were positive. These studies were published in toxicology journals, and the firm has since obtained GRAS status for AGEprost.
The company is currently filing for novel food status in Europe, as well as two-year registration in Australia.
"This is the first new product in the prostate health arena in a long time, and we make the extract from the leaves of the plant A. conyzoides, which we farm ourselves," said Venkatesh.
Now that the product had GRAS status, he added, its prospects in the US were encouraging, and Gencor would launch it this year with a top firm in the US market.
Venkatesh further revealed that apart from the ongoing regulatory approval process in Europe and Australia, the company had started regulatory registration for AGEprost in many other countries.
AGEprost comes in powder form, and its current applications are capsules and tablets.
Venkatesh said, "With the world's geriatric population increasing, we expect that this product will be an ideal solution for ageing men with prostate problems.
"All older men are bound to experience these problems to varying degrees. We see quite a good amount of potential, especially in Asia, for a product to be taken once a day in low doses.
"With Pharmako (Gencor's sister company), we have the delivery technology, so we will do more work to see if we develop a water-dispersible format, as well as increase the absorption and bioavailability of the product."