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The Pill, for the 21st century
Made-in-Canada male contraceptive could change the world of birth control

A Canadian scientist doing research in obesity found that inhibiting a gene's protein expression rendered male mice infertile. The discovery could lead to a non-hormonal birth control pill – and underwrite research in genetic disease.

More than 40 years after the Pill forever changed how men and women relate to each other, the ever-increasing possibility of a male contraceptive – one discovered and developed in Canada – could have further life-altering impacts.

Along with shifting the responsibility for birth control from women to men, the new non-hormonal contraceptive under development through the support and encouragement of the Canadian Genetic Diseases Network (CGDN) could also fund additional research on genetic disease.

The CGDN, which helped secure a patent for the contraceptive's technology, has set up a Vancouver-based startup company, RecepTide Pharmaceuticals Inc., to develop the non-hormonal pill.

"The RecepTide shares are all owned by the Canadian Gene Cure Foundation," says Dr. Ron Woznow, the CEO of the CGDN, "so any successes from the company will go back to fund research on genetic diseases. This could be an excellent example of how the translation of a basic research discovery can lead to sustainability in research."

Polling data in the United States and Europe indicate that a non-hormonal male contraceptive alternative has wide appeal because of the concern of potential side effects associated with long-term use of hormonal birth control.

"Market studies have shown there is a definite interest," says. Dr. Woznow. "The market in developed countries is men and women in committed relationships who want an alternative to female, hormone-based contraception. In the developing countries, the issue is primarily one of population control. The World Health Organization is supporting local governments in addressing this issue."

The potential pill, the result of groundbreaking research by the CGDN's Dr. Grant Mitchell and his colleagues at l'Hôpital Sainte-Justine and McGill University, is about a year away from preclinical trials. The preclinical development is funded by CONRAD, a U.S.-based contraceptive research and development program.

As with many scientific discoveries, Dr. Mitchell's discovery was part serendipity. He was studying fat metabolism diseases that affect adolescents, focusing his research on one gene associated with obesity. Knocking out this gene in a mouse failed to induce the metabolic condition but it did render the mouse infertile.

Further work in Dr. Mitchell's lab and the Biotech Research Institute in Montreal led to the identification of small molecules that inhibit the protein expressed by the gene for fertility. Inhibition by a small molecule is important, says Dr. Woznow, because it means a drug could be administered orally instead of intravenously, making it much more economical to develop and, ultimately, a more marketable commodity.

The researchers have found about 350 molecules that block the protein and are now screening them to find one to three that are effective without being toxic.

"We have a good idea as to which ones will be non-toxic and have the effect we're looking for," says Dr. Woznow.

That screening process will take one year to 18 months, after which – if all goes well – preclinical trials will begin. At that point, RecepTide will look to industry partners and/or venture capital investment – something it has not sought so far.

"We decided that it was too early to look for a venture partner for the technology, but if we got some additional results, then we would pursue partnerships," says Dr. Woznow. "We're in ongoing discussions with major pharmaceutical companies that have an interest in this." Also, CONRAD could be a continuing partner. "They are potential partners to fund clinical trials of a non-hormonal mail contraceptive."

Beyond recycling any dividends that RecepTide may earn back into research funds for genetic diseases, Dr. Woznow sees an opportunity for developing a pan-Canadian fertility company.

"There is a tremendous amount of research being done on fertility in this country and it could provide a critical mass for a successful biotechnology company. For example, a research team at the University of Calgary, led by Dr. Derrick Rancourt, has identified novel ways to enhance in vitro fertilization. A pan-Canadian fertility company would be attractive to potential investors who are often reluctant to invest in a single technology or product."

www.cgdn.ca

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