Sackville, N.B.-based biotech Soricimed Biopharma Inc. has signed a contract to conduct Phase I clinical trials at The University of Texas MD Anderson Cancer Center in Houston, Texas, meaning its drug candidate SOR-C13 will be tested at three North American facilities.
The drug has been in trials since last autumn at two Canadian facilities – the Juravinski Cancer Centre in Hamilton, Ont., and the nearby London Health Science Centre. In an interview yesterday, Chairman and Chief Scientific Officer Jack Stewart said the Phase I trials should take about a year.
SOR-C13 is a targeted peptide, or a small protein. This particular peptide can stop growth in cervical, bone and lung cancer cells. Pre-clinical studies have shown that SOR-C13 induces apoptosis (cell death), inhibits cell proliferation and reduces tumor volume while minimizing side effects associated with typical chemotherapy.
The Phase I trials are designed to show that humans can use the drug safely, and determine what size of dose can be comfortably tolerated by the human body. Stewart said the company will also be monitoring the tests closely to see what indications there are on the efficacy of the drug.
He said the plan for several years has been to seek regulatory approval simultaneously in Canada and the U.S., and Soricimed’s regulatory team has designed the trials to meet the conditions of approval for both the Food and Drug Administration in the U.S. and Health Canada.
By expanding to MD Anderson – where testing began on Wednesday – the company is basing its testing in facilities in both countries.
“You can’t get much better than Anderson based on credibility,” said Stewart. “It is probably one of the top three, four or five research institutes on the planet.”
In a usual biotech timeline, Phase I trials are followed by the more expensive Phase II trials, which are designed to establish the efficacy of a drug. Warning events always crop up to extend a timeline, Stewart said the Phase I trial should wrap up in 2014, after which the company will reveal its Phase II plans. Soricimed hopes that SOR-C13 could get to market in the next three to five years.
Soricimed has raised a total of more than $12 million in dilutive and non-dilutive funding.
“At the moment, we are looking at ways to raise more non-dilutive money,” said CEO Paul Gunn, referring to capital such as grants and awards, which do not dilute the equity base of the company. “Depending on how successful we are, we may look at raising more equity as well.”
Soricimed has said previously it plans to find a large drug company to partner with for the second and third phases, which together can cost hundreds of millions of dollars.
As of late 2011, Soricimed had raised almost $6 million from private investors in New Brunswick,and almost $5 million through the programs of Atlantic Canada Opportunities Agency and the National Research Council.