Maynard Firm Tests Compound To Treat Heart Damage
Ischemix LLC, a small Maynard biotech company, believes it has a promising solution to prevent the muscle damage caused by heart attacks and coronary surgery.
The damage is called ischemia-reperfusion injury and it happens when a blockage, like a clot, deprives cells of oxygen and nutrients. When blood flow is restored, more damage often occurs.
While there has been a lot of research into potential therapies, nothing has really emerged as a solid solution. That is until now.
Broken Heart
At Ischemix, researchers have developed a small molecule that acts as a dual-action drug. It blocks oxygen-free radicals and calcium overload, which are the primary causes of ischemia-reperfusion injury, according to Robert “Duffy” DuFresne, CEO of Ischemix.
Its compound, christened CMX-2043, will begin phase II clinical trials soon, he said. In animal tests, it has reduced the area of dead tissue by up to 40 percent compared to untreated animals. It has also been shown to be safe in Phase I human studies.
“There will be 120 patients in three different hospital settings,” DuFresne said. “All this is being done as an initial proof -of-concept that is designed to show a clear signal of therapeutic efficacy.”
And if phase II trials show that it works well in keeping ischemia-reperfusion injury down, then it will lead to bigger clinical trials in North America, DuFresne said.
For cardiologists, Ischemix’ treatment could hold promise. Dr. Craig Smith, director of the Coronary Care Clinic at UMass Memorial Medical Center in Worcester, who has no ties to Ischemix, said that no drugs have prevented or counteracted ischemia-reperfusion so far, although several initially held promise. And while induced hypothermia was originally thought to be an answer a number of years ago, it has since fallen out of favor, he said.
If clinical trials go well, Ischemix may face some choices in order to bring the compound to market.
“In the current environment where financing for biotech companies is tight generally, we would almost certainly have to have a much bigger partner or potentially be acquired to take the program forward,” DuFresne said.
They’ve already started discussions with multiple companies that he can’t name.
“There’s a great deal riding on this,” he said.
By early next year the results from the latest round of clinical trials should be known.
“If the assessment makes this data look encouraging, then we would begin the process of following up our contacts to find a serious partner or become an acquisition,” DuFresne said.
This would be a great turn of events for a lean, mean privately-owned research company with just eight employees.
The upcoming Phase II trials will be conducted at medical centers in India, once the company has its regulatory approval paperwork in hand.
The rate of coronary problems is much higher in India than it is in the United States, DuFresne said. And patients there begin having heart problems 10 years earlier than patients in America. They also have more multiple coronary disease problems.
According to the South Asian Heart Center at El Camino Hospital in California, Indians, Pakistanis, Sri Lankans and Bangladeshis, no matter where they live, experience coronary heart disease that is four times higher than the rest of the world’s population. A study among Asian Indian men found that half of all heart attacks among them happened to those under 50 years old and 25 percent under the age of 40, according to the center’s statistics.
It is not yet clear if the higher incidence of coronary disease among South Asians is due to genetics or diet or some combination.
But if CMX-2043 turns out to be a solution for ischemia-reperfusion injury, it could end up being even more meaningful for coronary patients in the country where it was first tested on a broader basis.
Got news for our Biotech Buzz column? E-mail WBJ Staff Writer Eileen Kennedy at ekennedy@wbjournal.com.
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