Welcome back everyone. Next, we have Aethlon Medical. It trades on the NASDAQ under the symbol AEMD. It's a clinical-stage biotech company developing the investigational Aethlon Hemopurifier, an extracorporeal device for oncology and other indications. Happy to welcome back CEO and CFO, Jim Frakes. Welcome back to the conference, Jim. We're looking forward to hear your update today.
Great. Well, thank you, Ana, and thanks everybody for listening in, whether this is your first time or if you've been following us for a while. I think I last spoke with Ana in late February, and this is very timely that, this brief chat we're having. We did have some news recently that was important to our little company, so I'm excited to catch everybody up on recent developments.
Perfect. Would you describe the oncology clinical study you are currently running in Australia?
Sure. Our Australian cancer or oncology trial is in participants with solid tumors that are not responding to a treatment regimen that includes immunotherapy with anti-PD-1 agents, pembrolizumab, also known as Keytruda, or nivolumab, better known as Opdivo. As a reminder, Keytruda is approved for over 20 cancer types, featuring over 20, 40 specific indications. It's the world's best-selling drug with approximately $31.7 billion in global revenue last year. Opdivo is approved in roughly 11-20 specific cancer indications, and it registered roughly $10 billion in revenue last year. Both are PD-1 inhibitors, treating cancers like melanoma and non-small cell lung cancer. While these are world-class excellent drugs, they, unfortunately, only help about 1/3 of the patients that are on these drugs.
Our goal is to try to help some percentage of the patients that are failing these drugs to perhaps improve their response. To answer your question, Ana, the design of the study is similar to a dose-finding study in the drug world. We plan to have three cohorts of three patients each. The first cohort was treated with the Hemopurifier once. I'll call it the HP from now on since it's a long word. In the second cohort, each patient was treated two times in a week, say Monday and Friday. In the upcoming third cohort, each patient will be treated three times in a week, Monday, Wednesday, and Friday.
Once data is analyzed from each cohort, we expect to learn a lot about the number of HP treatments that would be optimal for these types of cancer patients.
With that said, you recently received some positive news from the Data Safety Monitoring Board overseeing your ongoing clinical trial. Tell us about that.
Sure. Once three participants or patients were treated, they call them participants in Australia, not patients, were treated with the HP in cohort two, safety data was presented to the independent Data Safety Monitoring Board or DSMB. The DSMB met on March 23rd, just last week, and the DSMB could have provided us with two recommendations, either to recommend that we advance to the third and final cohort or enroll three additional patients to the second cohort based on a safety finding. I'm pleased to report that the DSMB recommended that we advance to cohort three, and we announced that decision in a press release last week.
While the primary endpoint of this trial is the incidence of adverse events and safety laboratory changes, what other outcomes are you evaluating?
In addition to monitoring safety, which is the primary endpoint, the study is designed to examine the number of HP treatments needed to decrease the concentration of extracellular vesicles, or EVs, also known as exosomes, and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. Now, I'd like to point out that the scientific rationale and full design of the study have recently been published in a peer-reviewed journal, BMJ Open, and the link can be found on our website. I encourage any interested party to click through to that article.
And.
In the first cohort, we reported favorable directional improvement in EV numbers and immune cell numbers that were observed in the cohort with the single HP treatment. We expect data on EV and T cell numbers from cohort two within three weeks from completion of the eight-week follow-up time point in the last treated patient. That was late February, as I recall. Sometime this quarter, we should have the data from the second cohort that we can announce. I'm really excited to find out what that data is.
Perfect. With all of this said, what are your next steps?
We have interested patients that were interested in participating in cohort two, but we completed the three patients necessary before they could start their treatments. We've given them paperwork to participate in the third cohort, which would, again, be three treatments. We've submitted the relevant paperwork to those patients through the principal investigators at the three hospitals in Australia. Something we haven't really talked about in the past, but I think it's important to understand the nuance. We need to time the HP treatments, again on Monday, Wednesday, Friday in cohort three, so that these occur the week before their scheduled Opdivo or Keytruda treatments.
If a patient at one of the hospitals is interested and signs the relevant informed consent forms, et cetera, it needs to be timed, and they have their Opdivo or Keytruda treatments roughly every three weeks, so we need to time the three HP treatments to occur the week before that next drug treatment. There is some nuance there that the hospitals are figuring out. That there are some logistics.
How soon do you think the third cohort will be enrolled?
Well, as I mentioned, we had interest and we have a queue of patients. I'll use the American term, the patients. We're going to get them to sign the paperwork for the third cohort, and I think we have three in the queue, and we have a couple of others that are interested as well. Some may fall out. The timing, vis-a-vis their Keytruda or Opdivo treatment, may cause a logistical issue. I would think we'd finish this quarter.
Great. How strong is the scientific validation of exosome removal as a therapy?
I think it's pretty widely known in the EV journals that metastasis of cancers where tumors travel within the body from one site to another, they're communicated by EVs or exosomes. If we can diminish this ability to metastasize, that should help the patients. That's a key area that we're focusing on.
Perfect. What does success look like to you in two or three years, Jim?
Finishing this trial, getting the data put together. It's all being compiled at the University of Sydney, which is a world-class institution with some experts on EVs. Publishing that will probably go first to Australia, to their equivalent of FDA. It's called the TGA there. Do a efficacy study, which would be a bigger study. We would pick the number of treatments based on what we've learned from this safety study. March forward toward eventual approval. That's the goal and dream here in this.
Perfect.
This little company of ours.
Perfect. Well, thank you so much for this update. Very important work you're doing, and we appreciate you coming back on, and we certainly look forward to continuing on this conversation with you.
Thanks, Ana. It was very timely. We're excited about the Safety Monitoring Board's decision. We look forward to keeping everybody appraised of our progress.
Perfect.
Thank you.
Well, great way to end our conference today with some positive news like that. Thank you, Jim, and thank you everyone. In just a minute, you'll be redirected to the registration page for our next conference next month. Reserve your spot early. On behalf of all of us at Emerging Growth, we'd like to thank our presenters and attendees for making this such a great success. Remember, a complete replay of this conference will be on our YouTube channel, and follow us on X at EmergingGrowthC. I'm Ana Berry. On behalf of all of us, we wish you a great rest of your week, and we'll see you next month.