Corinne Allen is the vice president of CytoDyn Inc., a Santa Fe-based biotech firm which, for the last 13 years, has been developing Cytolin, an innovative HIV/AIDS treatment the company says rehabilitates the immune system.
SFR: How did your company get its start?
CA:
We got started back in the mid-'90s when our CEO, Al Allen, saved hundreds of patients' lives with a unique AIDS treatment. Most of the people that invested in the company were the patients he had saved.***image1***
Is this a completely new paradigm compared to conventional treatments?
We haven't changed our paradigm in 13 years. We've been fighting the status quo all that time. The current standard treatment for AIDS, for instance, is antivirals and we have an immune-based therapy.
Can you explain the difference between antivirals and immune-based therapy?
Antivirals are drugs that want to kill the virus. Immune-based therapy fixes the immune system problem. Once a human is infected with HIV, the immune system gets the message that all of the CD4 cells, the T cells, the cells that are supposed to help the immune system, are affected. So, the CD8 cells, another part of the immune system say, 'We need to destroy those helper cells.' Our immune-based therapy stops that from happening so the immune system can control the virus. It helps the immune system control the virus so it becomes a chronic condition rather than a fatal disease.
And how often would someone have to get treatment?
That's being studied in the next clinical trial, but based on the earlier data we assume that it's about once a month. It's administered through an IV based on a person's weight.
Are doctors resistant to looking at anything that's not an antiviral?
Not doctors. The current antivirals standard was created by experts in the infectious disease area, and their approach has been to attack the virus. This is where Cytolin's inventor is sort of an unknown. Al Allen's a physicist, but Cytolin is based on scientific data, scientific theory and it was proved in pilot study after pilot study and clinical trial after clinical trial. The experts don't think that they've missed anything. They don't want to take a look at something new.
Is there a cost benefit to your immune-based treatment?
It's not as expensive to make. It's a protein that can grow antibodies, not an antiviral that has to be made over and over again because the virus builds up resistance. We estimate that the cost would be approximately $2,500 to $5,000 an infusion.
How many patients have you treated with this to date?
Back in the '90s when doctors were using this compassionately, we were able to collect data from 188 patients. That was just data collected by four doctors, and we knew for a fact that there were several other doctors that were using it compassionately.
What do you mean by 'compassionately'?
Compassionately means it's off label, it's not an approved drug. If you had a fatal disease, a doctor was able to prescribe his own recipe for you. You couldn't store it in mass quantities, you couldn't create an inventory, you couldn't make a profit off of it, but you could treat people with it.
What hurdles has the company run into in trying to get Cytolin on the market?
I think there's a big gap between the investment community and the medical community. The venture capitalists have their criteria for things that they look at and they don't look outside of that. For instance, I've been networking with all these venture funds in New Mexico that say they help start up biotech specifically, but they won't help us because we're already a publicly traded company. It doesn't fit their model.
If all goes well, how many years are you looking at?
If we can raise some money pretty soon, we can start with our trials. There are several hundred thousand people that are already resistant to antivirals. Those people would be able to get treatment while we are in clinical trials and at least we'd be able to help some people. That's within the next year or two.
There are huge AIDS epidemics going on in Africa. Will Cytolin benefit those communities?
We actually have a doctor on our scientific advisory board who's in the process of doing clinical trials [in Africa]. It's a different process and it's time consuming. Basically you have to buy insurance policies for all the families you're doing clinical trials on and you have to pay certain officials to be able to do the trials there. We do have a connection with a prominent figure in South Africa. We offered to save about 20 of their people and they would be willing to put up the money. We might be actually going down there real soon.
I have a soft spot for Africa.
It's horrible. People should be horrified. Generations of people are being wiped out and it's not necessary. Economics and education are the only things stopping us.
Santa Fe Reporter