A new treatment to alleviate suffering caused by cancer treatments is finally about to start clinical trials, thanks to $40,000 in seed funding raised by science and business joining forces, with Dr Pia Winberg from PhycoHealth, Dr Bora Kim and Professor Kate White from Sydney University, and proceeds from sales of a skincare range for all, BiomeBalance.
It was a rare chance meeting a decade ago of two scientists from very different fields – marine science and nursing – that opened up possibilities for a new seaweed formulation to help relieve mucositis in people receiving cancer treatment.
Dr Pia Winberg from PhycoHealth in the Shoalhaven was presenting at a symposium at Wollongong University on her unique seaweed molecule that mimics connective tissue in the human body. She had been working with Professor Fiona Wood on using the technology for severe burn victims, as well as other potential medical applications.
In the audience was Dr Bora Kim, who had recently finished her PhD and was conducting research at Sydney University on people suffering mucositis caused by cancer treatments. She immediately saw the potential. Could they create a formulation of this seaweed molecule to help protect and restore the mouth and throat, which can be severely damaged during treatment?
Relief From Suffering
Bora says: “Mucositis is quite common because the chemotherapy and radiotherapy itself is not cancer specific, meaning that it targets any similar rapidly dividing cells, like the mouth area and the GI tract.
“I approached Pia after her presentation and started chatting. I mentioned that we have such a problem in cancer care and at the time, the routine management was salted mouthwash, sodium bicarbonate mainly for antiseptic purpose but it has no healing property. Even now, that’s the standard practice so it hasn’t moved too much since then. Pia got quite interested because it’s not something she was aware of and that’s how it started.”
Pia says it was an exciting moment to meet Bora. “It’s hard to break barriers between researchers that sit in their own little labs doing things. Bora had finished her PhD and was doing research at Sydney University on patients who suffer mucositis, which is damage to the mouth mucus membranes. It’s a bit like you lose your hair in chemotherapy, you can lose the surface of your mouth as well and that can lead to you not being able to swallow.
“We’ve discussed now for 10 years about how surface tissue can be so badly damaged through chemo and radiation. It’s both the structure of the skin itself and the microbiome as well. Many people understand now that the microbiome in the gut is really important for our health, which is great, but people are still not fully aware that the microbiome on our skin is really important for skin health. So it’s in part delivering our molecule but formulating it in a way that helps the microbiome recover too.”
Clinical Trials Coming Soon
Working with Bora and Pia on this new formulation is Professor Kate White at Sydney University, who has spent her career in clinical nursing, especially in cancer and palliative care. Kate says of the upcoming trials: “We’re really focusing on patients who are having head and neck radiotherapy, so that means the radiotherapy is given to that area and it may include some of their throat.
“When we say mucositis, it means they end up with very deep ulceration all through their mouth and down their throat and they can’t eat. They get to the point where they can’t swallow saliva. We warn patients about it but no one really understands how awful it is until they’re there.”
Kate says the impact of this side-effect can have a devastating emotional impact on the carers and family of the patient, who see the distress and knock-on effects such as infection or pneumonia, or needing to be fed artificially.
Bora adds that conditions such as mucositis can interrupt or even end the main treatments, which reduces the person’s overall health and recovery outcomes.
“It has an impact on the treatment outcome as well, because if the patient is not tolerating the treatment, that means the dose needs to be reduced. If the patient needs to admit to the hospital to manage a local or systemic infection, that means there’s a treatment delay, which also impacts the treatment outcome, longer term survivor outcome.”
The team of Pia, Bora and Kate are now ready to test out some formulations. Kate explains: “Initially in our discussions with Pia and her colleagues and Bora, it was looking at testing out the formulation. We’re trying to work out whether this can be tolerated by patients, so what’s the substance or what’s the mouthwash, do we flavour it, do we not flavour it. We have a plan of trialling it and that’s really about the patient’s perspective of their acceptance of it.”
There are two other aspects to the initial clinical trials that the team is interested in, and Kate says gathering the evidence will help to secure funding for further trials. Firstly, can the formulation reduce the severity of mucositis, and secondly can the formulation speed up the healing process.
Kate says: “The reason why this is so important is that we’ve got so little we can offer. Essentially we often manage it with stronger pain medicine and sometimes patients are admitted to hospital because they can’t maintain their nutrition.
“We’re not suggesting by any means that this product is likely to prevent it from happening, but if we can reduce the severity then we’re reducing the suffering these patients experience and the suffering their family members have to watch and feel so helpless about.”
Awareness of Suffering
This condition doesn’t receive much public acknowledgement, which is another hurdle to research funding, because as Kate explains: “It may not be visible to people outside in the community because [sufferers] don’t go walking around because they can’t talk and they can’t drink so it is a bit more hidden.
“Family carers find it so distressing that they can’t relieve that person’s suffering. We all worry about not being able to eat so maintaining nutrition is a really important thing often for carers. It’s important for health professionals but usually that’s what’s pushing the carers buttons.”
Kate says this lack of visibility for the condition has been a hinderance: “Every time I meet with Pia and Bora, we walk away all excited and we have put in a couple of small grants but it’s a little bit too abstract, I think the mainstream cancer researchers scratch their head a little bit and go, it sounds a bit funny to me.”
Initial clinical trials will be crucial in taking this formulation to its full potential.
“It’s very hard to be competitive through the main funding schemes,” says Kate. We’re at that very early stage and many of those [schemes] will want you to have proven that. The other thing is we need it to be done within a research framework. We need to be confident ourselves in what we’re proposing and that it’s going to help patients.
“To get funding to do a bigger trial, we’ve got to bring up the evidence and that’s why it’s been great working with Pia, we’re all on that same perspective of showing how this works and what works. It’s the research aspects of it that cost.”
Seed Funding for Clinical Trials
“Head and neck cancer is on the increase and that’s not the only one, there are a whole lot of other conditions where we could potentially be using this product once we get past the first hurdles. So that’s why the funding is so important,” says Kate.
Finally, a clinical trial is in sight, with funds raised from sales of a special edition skincare range, BiomeBalance by Phycohealth – the same exciting seaweed technology that can be used by everyone.
Bora says: “We’ve got other competing priorities so unless there’s some solid or even seed funding that can help start, it’s very hard to pursue this sort of idea. We have engaged with Pia on and off for the past 10 years but it really hasn’t come to any fruition. Pia put forward an idea to do a fundraising instead, which was quite a good opportunity.”
Pia took action to bring business and science together with the formulations to drive everything together at once. She says: “We can create formulations for those trials but they’re equally good for people every day.
“Then we can take some of the margin from those sales to support the research and everyone’s part of supporting this research program, because many of our customers will know the pain suffered by patients in chemo and radiation therapy. With everyone contributing, it’s really motivating for us, we can get a project done that’s been so hard to execute until now.”
Pia asserts: “It will be human clinical studies with 10-20 patients using formulations that show the evidence and the potential for which formulations to work, to get statistical significance behind it. These are gold standard, double blind, placebo controlled human studies. They’re not like some skincare formulations talk about ‘clinically tested or dermatologically tested’. This is actual real wound recovery gold standard scientific research with the academic nurses at the University of Sydney.”
The funds are rapidly approaching the $40,000 target thanks to strong sales of the BiomeBalance special edition since the end of May.
Collaboration is the Key
This breakthrough research for mucositis treatment may never have happened, except for that chance encounter for Pia and Bora a decade ago. But all three in this team have seen the incredible potential of bringing different disciplines together on a problem.
Pia says: “As an academic myself, you always sit there going, oh we could do this, but it’s never until you meet the clinicians at the coal face that you understand really what the practical problem is they need to solve. In science, we go off to blue sky tangents and find the next thing that’s novel, but for clinicians in the hospital trying to heal a patient, it’s practical. For example, one way to prevent some of the skin damage could be like they do with hair loss, they put ice caps on the head because then the blood with the chemotherapy drug in it doesn’t go to the hair follicles and damage it as much. So maybe if we delivered the oral one in an ice block, I would never have thought of that. You can only know that because the clinicians can tell you, this is what happens, this is what patients have to deal with.”
Kate says: “For me, it’s just having my eyes opened for a product or the work that Pia is doing that has so much potential. I haven’t even started to go into the potential for radiation, skin reactions and dressings and kinds of stuff. I think it’s enormous. I love the fact that it’s Australian. I love the fact that it’s a particular seaweed that is found down south. There’s something incredibly Australian about all of that. This is us not only working together, but working with natural products and having a better understanding of nature.”
Pia concurs with that sentiment: “I think we need to be crossing tribes a little bit more. We sit in silos, whether it’s bureaucratic silos or academic silos or business silos or cultural silos, and we don’t meet enough and cross ideas and cross fertilise.”
PhycoHealth is currently working with some First Nations groups on new ingredients, such as oils from native plants, that can work in harmony with the hydrating, healing seaweed molecules. A recent round of crowdfunding for PhycoHealth is also going to expand their seaweed production, with new farms to be set up in Yamba soon.
Pia says: “The challenge of the world is not access to oil and resources like that, it’s actually getting people to collaborate again and working with the source of everything that supports life on earth: photosynthesis, plants, humans, food and that’s our policy within PhycoHealth, that nature, people, business, everything is part of an ecosystem. We try to bring that angle to our business and work with other people, other ingredients, with the market and what the market needs and work with government policies to make that happen and it feels like, with a crowd backing since last year in the skin treatment as well, we’re really doing it together, it’s very exciting.”
You can find out more about the BiomeBalance skincare range and purchase these products at PhycoHealth, and help raise funds for this important research.
Find out more about PhycoHealth’s new round of investment fundraising and their plans for the future, as they enter the final days.
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