‘At Naturamed, we seek to understand how to develop scientifically-based natural health care, and to exploit these findings.’A new Israeli company appears to have found a natural, safe and effective relief for a widespread, but often hushed up, ailment: enlargement of the prostate.

In recent clinical trials, a remedy derived from indigenous Israeli plants were comparable to those of conventional pharmaceuticals and better than those associated with current natural remedies. Of equal significance, the remedy – called Naturamed Bio Active (Nabia) – caused no side effects whatsoever.

Benign Prostatic Hyperplasia (BPH), the non-cancerous enlargement of the prostate gland, affects nearly 50 percent of men over the age of 60 and 80 percent of those 80 and above. While not fatal, BPH is extremely uncomfortable. An enlarged prostate triggers a need for frequent urination – night and day – and can lead to bladder obstruction, urinary tract infections and sexual dysfunction.

Treatment of early-stage PBH has been based mainly on two prescribed medications, alpha blockers and 5-alpha-reductase inhibitors. While generally effective, these drugs are costly, and are often accompanied by negative side effects ranging from dizziness to impotence.

Nabia, described as a “food supplement” by its creator, Naturamed Ltd., is the first natural product that demonstrates alpha blocker activity, the gold standard mechanism of drug treatment today, along with and 5-alpha-reductase inhibitor activity. It appears to possess the main mechanism of the pharmaceuticals that are used today – but with no side effects.

“In both in vitro laboratory tests and human clinical studies, this combination has shown to result in superior efficacy,” Naturamed CEO Dr. Harold Wiener told ISRAEL21c. “This synergistic operation is a landmark in herbal BPH treatment – it gives our company a huge edge.”

A scientist/entrepreneur who holds a PhD degree in chemistry from the Hebrew University of Jerusalem, Wiener founded the company in 2002, together with Russian-born biotechnologist, Irena Oleinik, now its scientific project leader. Today, the two manage Naturamed with Business Development VP Avi Gal.

From its beginning, Naturamed has been under the wing of the Misgav Technology Center, an government-funded technological incubator based near Carmiel that specializes in medical devices, homeland security and biotechnology firms. There it remained for an unprecedented three years. Equally unusual, the company initiated and completed its clinical trial while in the incubator framework.

The randomized, double-blind placebo-controlled trial was performed under the supervision of Dr. Oscar Kotliroff, head of the Urology Department at the Rebecca Sieff Hopital in Safed. The study assessed the short-term (16 week) efficacy of Nabia in 15 patients with lower urinary tract symptoms caused by BPH. Study results were compared with those from clinical trials on the commonly-used synthetic drugs, Finasteride and Alfuzosin, as well as Saw Palmetto (Serenoa repens), the gold standard of natural extracts for BPH treatment.

“More than 80% of patients in the Nabia trial reported a significant improvement in lower urinary tract symptoms,” says Wiener. “This is amazing for a completely natural product.”

In addition, Nabia was well tolerated. Comprehensive physicians’ checkups and laboratory testing revealed no adverse effects of any kind.

While this trial would not be sufficient for a pharmaceutical product, it was more extensive than studies for most other nutraceuticals. Says Wiener, “We are confident that the trial has proven our product’s complete safety and efficacy.”

What led Naturamed’s founders to the remarkable plant behind Nabia? Although the original idea came from a group of Russian scientists, it was based more on folklore than on science, according to Wiener.

“The researchers brought to my attention these plants that grandmothers and healers had used for centuries in Russia to treat symptoms of the lower urinary tract. Since this plant, which also grows in Israel, had such benefits, we thought it could be advantageous in treating the frequent urination associated with BPH,” he says. “For us, the plant’s alpha blocker activity – its most important aspect – was an unexpected extra.”

Wiener has consulted to the nutraceuticals (natural, bioactive chemical compounds that have health promoting, disease preventing or medicinal properties) field for more than 20 years. He points to several factors – along with the product’s own impressive properties – that have set the stage for Naturamed’s success. Israel is diverse, and the population is open to trying folk remedies introduced by different cultures. In addition, the country boasts topnotch research in such related fields as chemistry, biotechnology, medicine and nanotechnology, and an innovative and well-developed food industry. Finally, says Wiener, “In much of the world, a ‘green revolution’ is going on. Everyone is looking for natural remedies and Naturamed is riding the crest of this wave.”

Despite these advantages, Wiener has no illusions. “I am optimistic, though I know we are only at the beginning of a challenging journey,” he says. “It’s not enough to do good science, you have to market it properly.” Toward this end, Naturamed is now negotiating with potential partners in the US, Europe, Japan and India. The next test is gauging market response, “a crucial step,” says Wiener, which the company “is taking cautiously, in the best way possible and under no pressure of any kind.”

Unlike pharmaceuticals Nabia does not require FDA approval, but is required to undergo a six-month regulation process, which according to Wiener, “poses no problem since the plant is edible and has been known for centuries. We have simply isolated the active ingredient that gives a very specific advantage for BPH treatment.”

Currently focusing on Nabia, Naturamed ultimately plans to extend its range of products. The company would like to focus on areas of anti-aging and anti-oxidation. “We must understand the aging process and age-related degeneration on a cellular level,” says Wiener. “What causes aging and how we can improve the quality of life for those undergoing this process?”

In particular, Naturamed intends to pursue natural antioxidants as a defense against free radicals that damage cellular components like lipids, DNA and proteins. According to the free radicals theory of aging, this damage is at least partially responsible for the degradation that accompanies the passage of time.

While people are living longer today, they are not necessarily living better, according to Wiener. “Anti-aging is not just about living more years, but improving the quality of the years we have. We want to do good for people and at the same time build a successful venture,” said the Uruguay-born Wiener, a life-long Zionist who immigrated to Israel in 1978 with his wife, two days after their wedding.

Having built a career around the research, development and commercialization of natural products, Wiener has consistently tried to stress prevention over cure. “At Naturamed, we seek to understand how to develop scientifically-based natural health care, and to exploit these findings,” he says. “I’m happy we can link the commercial aspect with good health.”