John McCain in Phase 1 trial of Bexion’s solid cancer tumor candidate; Bexion who?

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The News:

In late September, the University of New Mexico Comprehensive Cancer Center (UNMCC) announced that the first clinical trials of a new drug that targets solid cancer tumors have now been conducted.

The Phase 1A clinical trials mark the first time ever the drug, called BXQ-350, is being used in people, according to Science Daily. BXQ-350 is comprised of a human protein called SapC and a human lipid called DOPS.

The trials opened at several sites across the country and patients like Sen. John McCain (R-AZ), with a type of brain cancer called glioblastoma, have new treatment options. Olivier Rixe, MD, PhD, at UNMCC, oversaw the clinical trials’ national protocol development and directed the Phase 1A trial in New Mexico.

The drug, called BXQ-350, has been shown in pre-clinical studies to induce cancer cells to die but have little effect on normal cells. It is produced by Bexion Pharmaceuticals LLC (Covington KY), a privately held biotech company, that focuses on cures for cancer.

Clinical researchers for the Phase 1A clinical trial tested the safety of BXQ-350. “It had a very good safety profile,” says Rixe. He hopes the drug will continue to show promise for those whose brain cancer has recurred. He is especially hopeful for those diagnosed with glioblastoma multiforme, a particularly aggressive brain cancer.

New cancer drugs and treatments go through a series of steps before the US Food and Drug Administration approves them for use in people. The entire process can take a decade or more and cost billions of dollars.

The early phases test whether the new drug or treatment is safe, what its side effects are, and what the best dose for treatment is. Later phases test whether the new drug or treatment works better than the standard therapy. All clinical trials in the US must meet stringent safety measures that the FDA enforces.

Rixe and his Phase 1 clinical trials team at UNM Cancer Center have completed 12 Phase 1 clinical trials in New Mexico.

“We offer what other cancer centers, like Harvard and MD Anderson, offer their patients,” Rixe says. “The patients treated at UNM Cancer Center are among the first in the world to be given this drug.”

(Source: University of New Mexico Comprehensive Cancer Center)

Steve’s Take:

I’m excited. And in the case of a Phase 1 trial of a potential cure for mostly incurable illnesses, it takes something mighty special.

There are literally thousands of mostly unknown, virtually invisible biotech startups toiling mightily in obscurity, focused on finding cures for aggressive and intractable diseases, especially cancer.

But when beloved (almost universally) war hero and former presidential candidate Sen. John McCain entered the Bexion trial following his diagnosis of glioblastoma–for which there is no current cure–a handful of us are now taking the matter quite seriously.

“These are tumors which are aggressive. They can be treated. They can respond to treatment, but usually they will come back. Treatment, the first step, is always surgery if it can be resected,” said Dr. John Breneman, associate director of the Brain Tumor Center at the University of Cincinnati.

The next steps in the process are radiation and chemotherapy over the course of a year. Even with this common treatment option, there is a 90% to 95% chance the tumor will return. Physically, the treatment can be draining. But it is possible to live a somewhat normal life.

“The side effects are pretty well-tolerated, and a number of people who have this diagnosis can continue to work during treatment,” said Breneman.

But who and/or what is Bexion Pharma? Certainly, Senator McCain has access to the top medical advisors and providers in the world, let alone the most promising treatments. The fact that he decided upon the company’s BXQ-350 candidate, sure got my attention once I heard about it.

Bexion Pharmaceuticals LLC, located in the Northern Kentucky community of Covington, has grown an accidental discovery by a scientist at Cincinnati Children’s Hospital Medical Center into a unique approach to treating cancer.

Since locating in Kentucky in 2006, Bexion has received matching funding from the commonwealth to support various stages of grant awards from the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) programs.

“Our office building is located in a neighborhood, essentially,” Dr. Ray Takigiku, president and CEO of Bexion, said. “People are out walking dogs. Great restaurants are within walking distance, and I can walk to work.”

The extinction of cancer?

Financial expert and commentator John Mauldin is a big proponent of Bexion. In his weekly newsletter, Thoughts from the Frontline, Mauldin noted that,

“Because it’s a Phase 1 trial, we don’t really have much information about how effective the drug is, apart from anecdotes; and distressingly, the researchers must sometimes stop administering the drug because that’s part of the required protocol. The rules simply want to make me pull my hair out.”

He adds, “In the US, one million people per year get cancer, and half a million die. Those are ugly statistics, but they could change drastically within less than 10 years. Cancer could become a nuisance rather than a threat to life.”

In the case of Bexion’s drug, treatment will (hopefully) amount to a few months or less of three visits per week, no side effects, and the cancer fades away–forever. That is the reckoning from mouse studies. We’ll know more after Phase 2 studies are underway sometime next year.

Steve's Take: @BexionPharma potential #cancer cure is definitely on my watch list! Click To Tweet

Incidentally, hedge-fund manager J. Kyle Bass put something out there in the category of good news/bad news that got me thinking. The founder and principal of Hayman Capital Management, LP, estimates that at least $500 billion of market cap in big Pharma will be destroyed by a cure for cancer. I say small price to pay, if and when that day finally arrives.

I’m officially adding Bexion to my watch list, now that my economist colleague and website partner J. Scott Moody, MA, apprised me of the piece by Mauldin–my first encounter with the company and its work the past 11 years. I suggest you also add the name to your investment watch list, and I’ll be sure to keep you apprised of clinical and capital developments.

I smell potential and perhaps profits in the future. But as we all have learned, this arena is so very speculative at this budding and super risky stage–even all the way through Phase 3 trials, where so many promising candidates ultimately flop. Stay tuned.

Steve Walker has no position in any stocks mentioned. MedContent Inc. has no position in any stocks mentioned. MondayMorning.com has a disclosure policy.