Local firms blaze trails to treatment
The region has a strong history of drug research coming from discoveries at area companies and the University of Colorado-Boulder.
The companies often partner with each other as well as with bigger bioscience and pharmaceutical firms outside of the region to help offset costs while developing new drug candidates.
Research and clinical trials to develop new drugs for market often take a decade or more before getting necessary U.S. Food and Drug Administration approval.
A sampling of what’s coming in 2013:
Clovis Oncology Inc.
Clovis Oncology Inc. plans to announce as early as the end of this year that it has a new, viable drug candidate to treat gastrointestinal tumors.
Boulder-based Clovis (Nasdaq: CLVS) is partnering with Array BioPharma Inc. (Nasdaq: ARRY) on the drug research. Financial terms of the deal have not been disclosed.
If all goes as planned, the company would move forward with additional trials on the gastrointestinal tumor drug candidate after initial findings are announced by Array, said Breanna Burkart, a company spokeswoman.
“We hope to identify (the drug candidate) at the end of the year,” Burkart said. “There’s not much to say until we have identified something.”
In addition, Clovis has two other candidate drugs in its research pipeline.
One is called CO-1686, a drug candidate to treat a form of lung cancer. CO-1686 is in an initial trial stage required by the FDA that identifies the safest doses for patients, Burkart said.
Clovis’s other drug candidate is rucaparib, which is used to treat ovarian cancer. Rucaparib is at about the same time frame as CO-1686 in terms of testing, Burkart said.
“It’s an important year for us to find out whether or not these drugs will be efficacious and offer benefit for patients,” Burkart said.
Clovis is focused on the new drug studies after seeing a disappointing outcome to a study on a drug candidate for pancreatic cancer in 2012. Clovis is returning the pancreatic cancer drug candidate’s licensing rights to Clavis Pharma ASA, a publicly traded company in Norway, Burkart said.
Clovis had $144 million in cash and cash equivalents and 26.2 million outstanding shares of common stock at the end of 2012, according to a quarterly earnings statement. The company said it expects to use $53 million to $57 million of its existing cash in 2013, and to end the year with about $90 million, according to the earnings statement.
This year, MiRagen Therapeutics Inc. plans to continue developing its two drug candidates related to the human heart.
First, the Boulder company plans to work on getting approval to sell a drug to treat pulmonary arterial hypertension. MiRagen executives signed an agreement earlier this year with two universities in the United Kingdom related to the drug candidate after collaborating with researchers at those universities.
A person with pulmonary arterial hypertension has abnormally high blood pressure in the arteries of the lungs, which is life-threatening because it rises to dangerously high levels and strains the heart.
MiRagen has a license agreement for intellectual property rights to the drug, according to Bill Marshall, the company’s founder and chief executive. Researchers at the University of Glasgow and the University of Cambridge found that the developmental drug helped stop the progression of some pulmonary arterial hypertension cases, Marshall said.
Separately, MiRagen researchers are working to develop a heart disease treatment drug.
Researchers looked at microRNA variations in human blood, and found particular molecules that appeared to indicate a worsening of heart disease, Marshall said. They’re focusing on a molecule they have named MIR-208 to come up with a new drug candidate.
Since coronary heart disease is the leading cause of death in the United States, such a drug could someday see big sales.
MiRagen is funded through venture-capital financing as well as a strategic alliance with French pharmaceutical company Les Laboratoires Servier signed in October 2011. The strategic alliance is to develop certain therapies for patients with cardiovascular disease which could someday be worth $1 billion in revenue, the company has said.
Siva Therapeutics Inc. has a novel cancer treatment that involves intravenously injecting minute metal pieces called nanorods into a cancer tumor in a patient’s body.
Such nanorods can be heated by infrared light from outside the body to shrink a cancer tumor, according to company literature.
Siva plans to be in the “pre-clinical” phase of approval with the FDA in about a year, said Len Pagliaro, the company’s chief executive. Siva recently received a $250,000 grant from the Bioscience Discovery and Evaluation Grant Program of the Colorado Office of Economic Development and International Trade to move forward with its work.
The company also recently hired two new workers and moved into laboratory and office space at 5541 Central Ave., Suite 140, in Boulder.
Siva must get a safety clearance from the FDA before moving forward with planned clinical trials, Pagliaro said. The company’s goal is to receive something called an “investigation device exemption” from the FDA, which could make the clinical trials approval process go more smoothly, he said. If the injection/nanorod process is classified as a drug, the FDA approval process might take much more work, he said.
“They’re giving you an exemption from the normal rules from going to market, and to do that, you have to convince them that you’re safe,” Pagliaro said.
Animal studies have been done that show the rods warm up when exposed to the infrared light, Pagliaro has said.
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