On Developing Non-invasive Cervical Precancer Treatments - Women's Health Series with Alia Rahman

Episode Transcript

[00:00:11] Claire Murigande: Is the healthcare system failing women? What do you think? 

Welcome to a brand new episode of Narratives of Purpose. This is a five episode special series, which is dedicated to female founders, advancing women's health. Featuring my conversations with the voices for change panellists at the first AI for life summit, which took place in Geneva, Switzerland in December, 2023.

[00:00:40] Alia Rhaman: The majority of cervical cancer deaths, uh, 90 percent of them occur in the developing world. And, you know, in the West, although the technologies that we have are fairly abhorrent and suboptimal in terms of the fact that they subject women to a lot of pain and suffering that, in my opinion, is unnecessary, at least we have access to the treatments however, barbaric they may be. But for so many women, particularly in Asia and in Sub Saharan Africa, there's just no access to treatment. And so very often if women do have access to treatment, they're getting over treated and that's not fair. So they don't get the advantage of the watch and wait paradigm like we do in high income countries.

Introducing Amplexd Therapeutics

[00:01:25] Claire Murigande: In this episode, I speak with Alia Rahman, co-founder and CEO of Amplexd Therapeutics. Amplexd is a startup on a mission to develop and commercialise non-invasive cervical dysplasia or cervical abnormal cell growth treatments that prioritise patient experience, access, and effectiveness. Their solutions address the often overlooked public health crisis of HPV, the human papillomavirus.

Introduction the Host and the Podcast

[00:01:54] Claire Murigande: If you're listening to Narratives of Purpose for the first time, let me introduce myself. My name is Claire Murigande, I am your host on this podcast, which is all about amplifying social impact. I bring you unique stories of changemakers, stories of people who are contributing to make a difference in society. By showcasing these individual journeys. I would like to inspire you to take action.

Please take a moment to rate and review our show. This will help other listeners find Narratives of Purpose. And further amplify the stories of impact that we share. For now, listen to Alia talk about navigating the healthcare system and her entrepreneurial journey with Amplexd.

Alia Rahman's Journey with Amplexd

[00:02:45] Claire Murigande: So welcome to the podcast, Alia Rahman. It's a great pleasure to have you today. And I'm really happy that you joined me before the panel. Can you please introduce yourself to the listeners and tell me more about your organisation?

[00:02:57] Alia Rhaman: Absolutely. Thank you so much, Claire, for having me. What an honour. We love the work that you're doing. So, uh, my name is Alia Rahman, as you've mentioned. I'm the co-founder and CEO of Amplex Therapeutics, and Amplex Therapeutics is on a mission to hopefully help eradicate cervical cancer.

So what we're in the process of developing are two products, one drug, which is intended to be used for low grades of cervical dysplasia. So that's a vaginal suppository, um, that is about to enter into clinical trials, hopefully in 2024. And it'll be used for 21 nights before bed and that should resolve low grade dysplasia. So in other words, if a woman had an abnormal PAP and she has low grade abnormalities, instead of her having to be put into a normal watch and wait treatment paradigm where she comes back every three to six months for monitoring, she would instead go home with a prescription. And the intention is that that would hopefully eradicate the abnormalities.

The second product that we're in the process of developing is a drug device combination, and it's actually a photodynamic therapy system that's intended for high grade dysplasia to replace, uh, typical conization and LEEP or LLETZ procedures. So it's intended to replace LEEP or LLETZ, or conization procedures that are excisional or ablative in nature, and instead of using light and fairly low intensity, but high enough to react with a photosensitizing gel that we've developed. And so that the light actually reacts with the gel to selectively target the dysplastic cells. And the intention is that it effectively mostly leaves healthy cells alone. So women wouldn't need anaesthetic for this. Uh, this wouldn't need to be done by a surgeon. This is an extremely low cost instrument that we're in the process of developing, and it's intended as sort of a cutting edge treatment for women in the West, but, um, you know, a treatment where nothing exists for women in the developing world that can be used by low skilled operators.

[00:05:04] Claire Murigande: That would be actually something less invasive.

[00:05:06] Alia Rhaman: This actually meets the criteria for non-invasive, and we've toyed around with calling it minimally invasive, but it's not, because laparoscopic procedures, I believe, are considered minimally invasive, but this is not actually cutting anything if this works clinically, it's uh, it should be the the most tissue sparing modality that would be available and it's considered completely non surgical.

So, you know just in terms of the scale and the scope, about 60 million women every year have CIN1 abnormalities And then another 10 or so million have CIN2, CIN3 abnormalities. But if you add the pre CIN1 phase, which is ASCUS, um, which we are intending to actually treat as well with our, uh, vaginal suppositories, that would add about another 90 million women onto that roster based on our own estimates. So that's about 160 million women every year who are affected by this condition.

And HPV, well, HPV is responsible for 5 percent of the world's cancer. So Pretty excited about this, but that's just a general background. I could go into more detail about it. Most exciting part for us is, you know, how we're really developing these so that they're accessible to all at a very low cost of production and manufacturing, and hopefully it stays that way.

Understanding Cervical Intraepithelial Neoplasia

[00:06:23] Claire Murigande: Alright, let's pause a minute here to explain some of the terms Alia just mentioned. So a system classifies disease severity based on how much epithelial tissue in the cervix has abnormal cells. It's called the cervical intraepithelial neoplasia or CIN, C I N, classified on a scale from 1 to 3.

CIN 1 refers to abnormal cells affecting about one third of the thickness of the epithelium. The epithelium in this case is a thin protective layer of compactly packed cells that line the outer surface of the cervix. CIN 2 refers to abnormal cells affecting about one third to two thirds of the epithelium. CIN 3 refers to abnormal cells affecting more than two thirds of the epithelium.

So, CIN 1 cervical dysplasia rarely becomes cancer and often goes away on its own. CIN 2 and 3 are more likely to require treatment to prevent cancer. Alia also mentioned the phase before CIN 1, ASCUS, A S C U S, it’s the abbreviation of atypical squamous cells of undetermined significance. It refers to abnormal changes which are suggestive of lesions but are qualitatively and quantitatively less than those of a definitive diagnosis.

Alia Rahman's Personal Experience and the Origin of Amplexd

[00:08:01] Claire Murigande: Tell me, why did you start this company? I mean, how did you start it, basically? And I know from the previous person I was speaking with, so who will be on the panel with you, it's very much patient led. So what is your background? What is the origin story of this company?

[00:08:14] Alia Rhaman: My story dates back to roughly 2007 or 2008 when I went from having a normal pap screening one year to the subsequent one being abnormal, and then I went for a colposcopy and some biopsies and it came back as CIN3, which is also known as carcinoma in situ, and it was quite surprising because the previous year's screening was clear, and I have various hypotheses about why that happened, but in any case, I was subject to a procedure known as laser conization, so that's using a hot knife.

And this happened in the Canadian health care system where we have, you know, a fairly good standard of care. And yet, I was given only local anaesthetic despite asking for general anaesthetic. I wasn't given any sort of pre-op information. I was just told to show up at the hospital at this time. And, you know, the surgery itself was done in a ward. It wasn't even done in a surgical room. And I could hear somebody next to me vomiting, for instance. Which was just adding to the stress. In any case, they, you know, they numbed me and I told them that I still wasn't numb. And at that point, the physician had already commenced and he said, you know, too bad, it's, we're almost done because it's a fairly quick procedure. But imagine feeling a laser, you know, in your most private areas.

And the consequences of this surgery weren't explained to me that this could affect fertility later on. And I was only 21 at the time. So none of that was explained. They acted like it was as simple as a dental procedure or something, really not taking into account the sort of intimacy and all of the shame and stigma that that comes with something like this, because I was a university student at the time, and it wasn't like I was going to tell all of my classmates that I just had the surgery. Whereas if I had, you know, a broken arm, It would be visible and you can talk about it pretty openly what happened to you. But when you get a sexually transmitted infection, it's not typically something that you're super open about.

[00:10:05] Alia Rhaman: So I went through this procedure and then it resolved the infection for a period of time, but then, um, I kept having abnormalities because presumably given the size of the HPV virus, there was probably some, you know, remaining virus within my cervical epithelium because it's not like I got a radical hysterectomy.

And I suspect that that's why I continued to have these flare ups and I continued to have the abnormalities. And then several years later, I required, I'm using air quotes, uh, I required another surgery because I had flared up to basically the cusp of CIN2, CIN3. And because I had a history of high risk HPV, my new gynaecologist wanted to perform a LEEP procedure. And I said, look, from what I've reviewed in literature, if a woman has two or more of these procedures, it can really compromise the ability to become pregnant and carry a pregnancy to term. So, you know, is there any alternative? And he said, no, there, there isn't.

And I said, well, I've been doing my own research. And I've seen that there's a compound known as EGCG, which is, um, it's a polyphenol of green tea. It's been used in other FDA approved drugs. And in any case, I mentioned this to him and he said, well, I don't believe that it works. I think, you know, it's just sort of spontaneous regression in the case of those women. But I thought, okay, I, from what I've reviewed, I think it could.

[00:11:27] Alia Rhaman: Then I met with a functional medicine doctor who suggested that I compound my own suppositories at home, which I did. And, in a very short period of time, I was able to regress the infection after self treatment down from CIN2, CIN3 down to CIN1. So, then I was put back in a watch and wait holding pattern.

And, then I started to get kind of crafty and thought, well, what if I could just get rid of this nasty infection and the lesions altogether, rather than just controlling them at the CIN 1 rate. So I had a hypothesis. I was running another medical company at this point, and we were working with some coronaviruses. And so I had a much better understanding of virology and was just exposed to a lot more literature. So I had this hypothesis to combine the EGCG with another molecule, and had no idea what would happen, and then I went for a combined PAP and colposcopy, and it came back completely clear for the first time in over a decade, which was amazing because I really thought I just had to live with this forever.

So that's how it all started. And then to make a very long story short, somebody who was advising for my previous company ended up becoming my co-founder in this one. And he's a well known pharmacologist.

[00:12:36] Claire Murigande: Wow. Impressive.

Amplexd’s Mission

[00:12:37] Claire Murigande: So when did you start basically building the company?

[00:12:39] Alia Rhaman: So we started this in December of 2021, January of 2022. And within six months we had, uh, filed our provisional patents. So we moved very quickly. It was all self funded well into the preclinical work. Um, so we prototyped two drugs on a medical device with our own money, which is kind of unheard of and paid for a lot of the preclinical and in vitro studies. Um, so now we do have some financing and, you know, we're always looking for more, as is the case with these things, but we're gearing up to hopefully start clinical trials in 2024.

[00:13:18] Claire Murigande: And so what is your overall objective now being part of this panel, this conference?

The Role of AI and Technology in Healthcare

[00:13:22] Claire Murigande: So it's all about AI, obviously, in healthcare and how technology can improve healthcare. So what are your, uh, your personal objectives and also, you know, representing your company?

[00:13:31] Alia Rhaman: Well, that's a great question. And when Fatou invited me, I asked exactly that, like, what am I doing here? Because we're in the physical products space. So the focus for me is really decentralisation. And that's one thing that is often discussed with AI, how it can obviously be used for evil, but it can be used to democratise it's just like a knife. Any technology can be used for good or evil. Same is true of all other technological advancements.

And so I'm really going to be focusing on the decentralisation aspect. So the majority of cervical cancer deaths, uh, 90 percent of them occur in the developing world. And, you know, in the West, although the technologies that we have are fairly abhorrent and suboptimal in terms of the fact that they subject women to a lot of pain and suffering that, in my opinion, is unnecessary, at least we have access to the treatments, however barbaric they may be, but for so many women, particularly in Asia and in Sub Saharan Africa, there's just no access to treatment. And, so very often, if women do have access to treatment, they're getting over treated, and that's not fair, so they don't get the advantage of the watch and wait paradigm like we do in high income countries.

[00:14:42] Alia Rhaman: So with the technologies that we're producing, the intent is not only to make things better for women in these parts of the world, But to really improve standard of care where there really is none and when we were developing our treatments I had told my co founder who's used to making designer drugs that cost I don't even know how much per treatment, but that's his 37 year career has been devoted to making really wonderful things but obviously quite expensive and when we started this project one of the design constraints that I gave him was that This has to be commercializable at a level that is less than the price of a cup of coffee or a cup of tea in each of the geographies.

So that was the barometer and he looked at me like I was crazy and he said, Alia, nobody can develop drugs for that amount, let alone manufacture them. And I said, well, we're just going to figure out a way. And so now the prototypes that we have, um, are extremely low cost to produce, and they look at least like they're going to be very effective in the clinical trial, so we'll see what happens, but I'm really focusing on this democratising access, because especially when it comes to public health and sexual health, if you can't, you know, make something that's accessible to everyone, then what's the benefit? That's my perspective, at least.

The Future of Women-led Innovation in Healthcare

[00:15:59] Claire Murigande: And what is your take on the current status of, you know, innovation, especially like women led innovation within health care, even patient led, you know, in this case, and especially in this panel, it's mostly about the lived experience and people saying, No, that's enough. We don't want that anymore. We have to do something about it.

What is your perspective today? And what is your outlook? How's the future look like from your point of view?

[00:16:20] Alia Rhaman: Okay, well, I'm both optimist and pessimist. As a scientist, I'm a pessimist. But, on the level of humanity, I'm an optimist. In our cas, honestly, we've been incredibly privileged. We raised money less than a year after incorporating and a sizable chunk. So my experience has been very, very different. And really, I'm the only forward facing member of the company and we don't really have any staff. We have some contractors that work with us and that are supporting us on our journey. But we have, um, Um, not necessarily fit into the normal paradigm that a lot of, um, female led companies fit in. So I just want to stipulate that because I am incredibly grateful. So it shows that you can break out of that.

However, that doesn't mean that there isn't much that we need to improve upon. And just from my own anecdotal experience, uh, and spending the last 24 or so hours with, um, the incredible women that are going to be on this panel. I am just so impressed at their dedication and devotion and, you know, if I had money to invest, I would invest in them because I believe that they would be incredible stewards, uh, from a fiduciary standpoint, you know, like I would trust them with capital and that's not always the case with, um, some of our more impulsive counterparts who, you know, seem to raise money quite easily.

So access to capital is going to be a very big part of this. Um, I think there need to be more, uh, female led unicorns that are created and I think that then things will shift. We've all obviously seen that with a few female led companies getting IPOs in the past couple of years, but that's one thing.

[00:18:05] Alia Rhaman: The other thing is that at the end of the day, women's health is, it shouldn't be a special subcategory because obviously it's affecting 51 percent of the population. But more than that, women in many, many parts of the world are the lifeblood of the economy. And they're very often taking care of not only their children, but their spouses, their parents, aunts, uncles.

So, you know, that economic loss is so massive. And I think that there's a public policy and an economic aspect of this, too, that that has to be emphasised. So, yeah, I think the future is bright, but there's also aspects of it that are kind of bleak at times. And I think really forming communities is such an important way in introducing people to one's network. And, you know, sharing contacts as much as possible, because that's how we're going to do this, by building bridges, not by tearing bridges, not by tearing each other down.

[00:18:56] Claire Murigande: Absolutely. I couldn't agree more. Thank you so much. And I'm really looking forward to the panel, to the discussion, and to hear from the other panellists. So thank you very much.

[00:19:04] Alia Rhaman: Thank you, Claire. Really appreciated it.

The Importance of Funding Women-led Startups

[00:19:09] Claire Murigande: The healthcare system has indeed been failing women. Did you know that historically, medical research has often excluded women? They entered the clinical trials only in 1993. 80 percent of the drugs removed from the U. S. markets between 1997 and 2000 were withdrawn because of side effects that occurred mainly or exclusively in women. Women's health has also been considered a niche area. Mind you, women account for roughly 50 percent of the world's population.

Now, that being said, things are starting to change. More and more women are advocating for their own health needs. They are creating impactful solutions with proactive And inclusive approaches. I truly believe that patients' lived experiences should be at the core of healthcare innovation. And let's not forget that there is a huge need to fund startups led by women. In fact, according to research by the European Investment Bank, in the U. S. alone, just 2 percent of investments in startups are for women led ventures, although 38 percent of startup founders are women. Staggering numbers, right?

Closing remarks and further resources

[00:20:26] Claire Murigande: If you are curious to learn more from some of our previous guests addressing these issues, check out episodes 22, 38, 42, and 63, focusing on women's health, as well as episodes 1, 11, 33, and 60 discussing the gender funding gap and impact investing.

Thank you so much for tuning in today. I appreciate you taking the time. That was my conversation with Alia Rahman at the first AI for life summit. You'll find more information about Amplex therapeutics on their websites at www.amplexd.com. That's A M P L E X D. com. Be sure to listen to the other episodes of this special series featuring my interviews with the four panellists of “Voices for Change: women's health and patient experiences”.

If you enjoyed this episode, please share it with a friend, with a colleague, or even with a family member. And don't forget to leave us a review on our website using this short link www.bit.ly/narrativesofpurpose. You can also connect with us anytime and follow our activities through our LinkedIn and Instagram handles at narratives of purpose podcast. Until the next episode, take care of yourselves. Stay well and stay inspired.

[00:21:57] Claire Murigande: This episode was created in collaboration with Stephanie Trang at Artefact Open Innovation Switzerland. This podcast series was written and hosted by Claire Murigande. This podcast was edited and produced by Tom Evan Hughes at Rustic Studios.