Retired UTEP professor Dr. Donald E. Moss has been working for over 30 years to bring his Alzheimers medication to market. He's hoping to get it done before his patent runs out.
Retired UTEP psychology Professor Donald Moss is on a mission to rescue more than 30 years of work and finally get his Alzheimer's drug on the market.
"This is the last chance. If we can't do it, a very good drug will be lost. It will just sink into the sand of time and disappear as though it never existed," Moss said last week from the office he still keeps inside the University of Texas at El Paso psychology building. "I know it works. I've seen it work. I will not throw it away."
Moss, 68, in the 1980s identified methanesulfonyl fluoride, or MSF, as a chemical that, he said, can restore some memory functions in Alzheimer's patients for several years so they can live better lives.
MSF doesn't stop Alzheimer's advance
in people, but it "will rehabilitate their mental functions" for a few years so they can function better and stay out of nursing homes, Moss said.
Moss late last year formed Brain-Tools, an Oregon drug company, with James Summerton, a former high school classmate and owner of another Oregon drug company, for the purpose of getting MSF on the market.
The problem is the new company needs $30 million in the next two to three years, including $3 million by the end of this year, to get through the Food and Drug Administration's new-drug approval gauntlet, Moss said.
Most of the money is needed to do further FDA-required tests of the drug on animals and people.
Moss and Summerton hope to get much of that money through
crowd funding, a growing form of online solicitations of relatively modest contributions from large numbers of people. Facebook, Twitter, and other social media have made crowd funding more feasible. For example, Spira, an El Paso running shoe manufacturer, raised almost $43,000 last year through crowd funding to help pay for making and launching a new shoe.
"It's enormously daunting," but worth a try, Moss said of the fundraising effort. "Also, we're hoping someone will come along that is interested in Alzheimer's" and possibly write a big check, he said.
Summerton said he knows of one organization that's done well with crowd funding -- Kiva, a San Francisco philanthropic organization that provides microloans for enterprises and projects aimed mostly at helping poor people in Third World countries. Since 2005, Kiva has used crowd-funding techniques to raise more than $400 million in small loans from thousands of people, according to its website.
What Summerton hopes, he said, is Brain-Tools can raise at least $3 million through crowd funding to pay for required tests of MSF on animals, and then get a government agency interested in helping pay for required clinical trials on people.
Summerton, who operates Gene Tools, a 15-year-old company producing gene-modulating agents for research labs, said he's already invested $1 million of his own money in Brain-Tools.
"I think he (Moss) has a hell of a good product," not only for Alzheimer's but possibly for treatment of old-age memory loss in general, Summerton said.
He and Moss became partners after talking during their 50th high school reunion last summer in Colorado.
Moss and a startup company that had wanted to get the drug to market have done enough development, including three clinical trials, to make MSF a better risk than developing a drug from scratch, Summerton said.
Moss has been through a years-long roller coaster ride in his journey to get MSF on the market.
In 1998, after Moss and UTEP received a patent for MSF, a large European drug company became interested in the drug, and it appeared ready to start the market-development process, he said. But the company discovered the patent was written wrong by a University of Texas system-hired lawyer and it was deemed worthless, Moss said. The patent had to be rewritten and resubmitted for patent approval by UTEP. By the time that was done, the company lost interest, he said. Other companies showed interest over the years, but nothing ever materialized.
"It's been a tragedy of errors and mismanagement" by officials from the UT System, UTEP and even himself, Moss said.
Moss' hopes rose again in late 2008 when a Swiss entrepreneur formed a startup company, SeneXta Therapeutics, to develop MSF and get it on the market. UTEP, which owns the MSF patent, formed a licensing agreement with SeneXta, and UTEP officials in early 2009 held a well-publicized event to herald the agreement.
Enrico Braglia, the Swiss entrepreneur, said in an email last week that SeneXta advanced MSF's development in the past four years, including doing a successful safety test of the drug on patients in a German clinical trial.
"Unfortunately due to the financial crisis (during the recently ended global recession), we were not able to raise the funds to continue the project" to the next phase, Braglia said.
"From the experience É we are confident of the potential of MSF as an interesting candidate to treat Alzheimer's patients and other diseases," he said. "Of course, MSF needs to be (more) fully investigated on its characteristics, efficacy and safety profile."
Federica Pericle, associate director for biotechnology at UTEP's Center for Research and Entrepreneurship and Innovative Enterprise, and a former partner in SeneXta, said the company spent almost $2 million on MSF's development.
"We believe in it, but we had no money to continue development," Pericle said.
Bragila said Brain-Tools and SeneXta signed an option agreement in December giving Brain-Tools exclusive rights for one year to analyze SeneXta's MSF data.
"They cannot use any data before entering into a final agreement," he said.
Moss said Brain-Tools "needs to buy SeneXta's data, and we have an option do that while we raise money."
"At the end of the year, we can consummate the option and step in where they left off," Moss said.
Another problem is UTEP's patent on MSF expires in August 2015. After that, any company could step in and develop the drug if it wanted, Moss said.
However, that's not likely since Brain-Tools has access to SeneXta's data as well as data Moss has from what he said were successful patient trials of MSF in the 1990s in Chihuahua, Mexico. That puts Brain-Tools at least three years and millions of dollars ahead of anyone who wanted to start from scratch, Moss said.
Brain-Tools plans to apply to the FDA for orphan drug status for MSF. That status can be granted to a drug that's losing or lost its patent, making it financially difficult to take the regular drug-approval route, Moss said. That status would give Brain-Tools exclusive rights to MSF for seven years, Moss said.
However, if the company fails to get that special status, then Brain-Tools would probably try to get MSF approved as a generic drug even though that would mean any company could decide to manufacture MSF and become potential competitors, he said.
Moss and Summerton want to sell MSF at a price that translates to $1 to $2 per day, well below the $9 per day that large pharmaceutical companies sell other Alzheimer's drugs, Summerton said.
Brain-Tools would make millions of dollars instead of billions of dollars, Summerton said. But MSF sales would generate enough money to repay contributors, pay SeneXta for its development costs and keep the company operating, Moss and Summerton said.
Moss said Alzheimer's drugs now on the market are not very effective and have lots of bad side effects. MSF's clinical trials have shown it does not make people sick. Moss himself took the drug for about three months in the 1990s with no problems, he said. The drug substantially improved the memory and quality of life of two Alzheimer's patients during his tests in Chihuahua, Mexico, in the 1990s, Moss noted.
Drug companies and other researchers are mostly focused on finding a drug to stop Alzheimer's, not on producing a drug like MSF to help people who already have the disease -- an estimated 6 million people in the United States today and growing, Moss noted.
Moss this year self-published a book documenting his MSF struggles ("Alzheimer's -- My Journey to a Next Generation Treatment").
"A little bit of me seems to die each day as the patent clock runs down to zero and this story of triumph and tears comes to an end," Moss wrote toward the end of his book. "The triumph was the study in Chihuahua where the patients showed dramatic improvement. The tears are for the millions who are suffering with dementia without getting the benefit of the best available treatment.
But Brain-Tools has again raised Moss' hopes for getting MSF on the market.
"The reason I think we can do it is because the drug works. And I don't think that people interested in Alzheimer's are going to let a substantially more effective drug die," Moss said.
Vic Kolenc may be reached at vkolenc@elpasotimes.com; 546-6421. Follow him on Twitter @vickolenc
About Brain-Tools
- To learn more about Oregon drug company Brain-Tools and its work, go to its website at brain-tools.com
- Hear Donald Moss talk about his work Thursday on Alzheim-er's Speaks Radio at blogtalkradio.com/alzheimersspeaks
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