ImaRx Therapeutics, a biotech company developing a new ultrasound-based stroke treatment, has moved its headquarters from Tucson, AZ, to Redmond, WA, as it attempts to get back on its feet again after a one-two punch of devastating setbacks.
ImaRx (Imm-uh-Rex) is led by CEO Bradford Zakes, who formed his connections with the Seattle area from 2001 to 2005. He spent those years at Bothell, WA-based Icos directing outsourcing operations for the hit erectile dysfunction drug tadalafil (Cialis).
Zakes’s new company is a reclamation project—he didn’t try to pretend otherwise in our conversation—but it sounds like one with potential to make a big difference in treating stroke patients. Current clot-dissolving drugs, like Genentech’s alteplase (Activase) can only be used within about three hours of an ischemic stroke in which clots block access of blood to the brain. The ImaRx technique theoretically could be used for several hours later, giving doctors enough time to salvage significant parts of the brain from being damaged, Zakes says. Stroke is the third-leading cause of death in the U.S., killing 160,000 people each year, and the No. 1 cause of adult disability, according to the National Stroke Association.
The opportunity was big enough to entice IPO investors to buy 3 million shares at $5 each in July 2007, but things went downhill fast from there. ImaRx halted a clinical trial of its lead SonoLysis product candidate for stroke last May, after three patients developed serious bleeding episodes in the study. Then, its one commercially available product, urokinase for busting up blood clots in the lungs, was forced off the market by the FDA until thorough tests could be done to prove it was still stable after sitting around in inventory. Those events forced the company to lay off all of its 50 employees except two, and caused the company’s stock (NASDAQ: IMRX) to evaporate to just mere pennies last fall, until it was de-listed in November.
So who cares now, and what is left to salvage? Not much cash is left, just $2.4 million in the bank at the end of September, according to its last quarterly report filed with the SEC. Still, Zakes says the company has more than 100 patents, more than a decade of development work with world-leading stroke physicians, and a $500,000 grant from the National Institutes of Health to do another clinical trial. The cash should be enough to last through 2009, he says. Most importantly, Zakes sounds determined not to be written off. He has some promising clinical trial data that has been accepted as a late-breaking presentation at the International Stroke Conference next month in San Diego, which he hopes will open the eyes of potential partners and investors.
“We think we still have exciting components to build an important biopharmaceutical firm,” Zakes says.
It makes sense for ImaRx to try to get re-established in Seattle because of its long history as a hotbed of ultrasound technology, and because Zakes has strong connections as an “expatriate” from the local biotech scene, says Chris Rivera, president of the Washington Biotechnology & Biomedical Association. ImaRx still has just two employees, Zakes and an accounting director. “It’s a small company, but every one we get is a victory. We’ve got to keep the momentum going here,” Rivera says.
The ImaRx technology is designed to use a combination of standard clot-busting drugs along with its proprietary lipid “nanospheres,” small enough to penetrate inside blood clots. These nanospheres are injected intravenously, embed themselves into the clot, and are gently jostled by a low therapeutic dose of ultrasound to the brain, Zakes says. The ultrasound waves are supposed to make the clot gently expand and contract until it dissolves over about an hour. The operative word is gently, because if the clot is busted up too fast, most stroke patients have leaky vessels that can’t handle the sudden rapid blood flow. Opening up the floodgates too fast could lead to severe hemorrhaging, Zakes says.
The data so far on the ImaRx technique is mixed. A trial of 18 patients who took one vial of the ImaRx nanospheres in tandem with ultrasound had positive results, which will be presented at the meeting next month, Zakes says. But trouble showed up in a group of 18 patients who got two doses, he says. Three consecutive patients in that group ended up having severe bleeding episodes, although if the trial had been run properly, they shouldn’t have happened at all, Zakes says. All three patients had severe high blood pressure that was supposed to keep them out of the trial, one also had an overdose of a clot-busting drug, and the other had the bleeding occur on the other side of the brain that wasn’t subjected to ultrasound, he says.
It will be interesting to see if doctors buy this explanation when the full data are presented next month. For now, ImaRx is focusing on turning around with a three-part strategy. The first step is to run tests that can demonstrate its ultrasound technique is at least equivalent to existing methods, so it can get commercial approval for an ultrasound technique that’s more convenient, Zakes says. That should only take 18 months, he says. At the same time, it plans to run the NIH-funded clinical trial of its ultrasound device in combination with a clot-busting drug. The third element would involve trials that bring back its nanoparticles, which could allow doctors to treat stroke for several hours after the original three-hour window passes.
If it all sounds like a long shot, it probably should, but that is the nature of the biotech business. Seattle is home to more than 5,000 people who make a living in the ultrasound business, so there is a pool of potential partners and employees if ImaRx can make good on any part of its strategy. “Seattle is a powerhouse in ultrasound, and for that reason alone we felt it was a good place to re-establish the company,” Zakes says.
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