Just received this email about previously named ERSO.... now ERX-315

[Trissh]

ERX-315 CLINICAL TRIAL APPROVED BY HREC

Inbox

4:22 PM (3 hours ago)

to Ilona

Dear Patients and Caregivers,

We are excited to announce that last night we received formal notification from the Australian regulatory authorities that our Phase I clinical trial was approved.

We have also included our release below:

ERX-315 CLINICAL TRIAL APPROVED BY HREC

Etira is pleased to announce the approval of the ERX-315 Phase 1 clinical trial by the Australian Human Research Ethics Committee (HREC). This HREC approval enables the start of the clinical trial titled "A Phase 1 Trial of ERX-315 in Participants with Advanced Solid Tumors”.

The trial will begin to recruit patients at The Kinghorn Cancer Centre in Sydney and be overseen by the overall trial principal investigator, Dr. Rasha Cosman, the Head of Early Phase Clinical Trials Unit and the Clinical Lead of Oncology Clinical Trials at the Kinghorn Cancer Center. The trial will evaluate the safety and tolerability of ERX-315 in in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. We anticipate that the Kinghorn Cancer Center will start screening patients for the trial by the end of August 2024.

ERX-315 is designed to target specific pathways that are critical for cancer cell survival and

proliferation. This targeted approach helps to spare healthy cells, potentially reducing side effects commonly associated with cancer therapies.

Interested individuals can learn more about the trial, eligibility criteria, and how to participate by visiting the link ERX-315 Clinical Trial.

Etira will provide updates on the continued progress of the ERX-315 clinical trial and activation in additional clinical trial sites in Australia. This clinical trial represents a significant step forward in Etira’s pursuit of effective treatments for patients with metastatic therapy-resistant cancers.

Best regards,

Ilona

etira.life

Our mission is

more than remission.

[Kerryd22]

Interesting. The Kinghorn Cancer Centre is a private health clinic not a public hospital so participants will be required to pay a gap fee which is of indeterminate cost although costs are discussed before beginning treatment as long as the patient enquires.

It’s associated with St Vincent’s Hospital and the Garvan Institute. And it’s a relatively small clinic in Sydney.

As there’s the suggestion that other clinics will also participate, hopefully public hospitals in other states will become involved. Australia is physically a large country but major centres are few and far between.

I wonder how Australia became the first country to approve a trial? That’s far from the usual practice. It’s good news that a trial is starting so best not to look a gift horse in the mouth!

[Chamisa in reply to Kerryd22]

I don’t think this is ErSO but similar. My understanding is that it is easier to get phase 1 trials approved in Australia, but that the FDA accepts the trial results. So, after the phase 1 trials are done, maybe phase 2 will open up to locations closer to those of us in the US.

[Trissh in reply to Chamisa]

Yes, it appears that teq103 is the new erso and erx-315 is another drug with new mechanism of action to destroy the cancer cells. Both appear to offer hope! Keep them coming!

[TammyCross in reply to Kerryd22]

Clinical trials are free. When I was in a trial, all my appointments and tests were covered.

[Kerryd22 in reply to TammyCross]

That’s good not that it will make any difference to me because I’m in a different state.

[Kiss_my_grits]

thanks for the update! Will you participate?

[LDR1]

This is good news! But I wonder why this seemingly promising drug has had such a slow path to an initial trial, now being done at a small center in Australia. If it was so promising why didn’t it attract more corporate and research interest? I mentioned ERSO to the head of Dana Farber’s Phase-1 trials recently and he had never heard of it. And he seems like a pretty smart, well-informed guy. I’m curious why this has languished. Anyway maybe if this initial trial is promising it will attract more interest…

[Gingerann1]

Wow! We’ve been waiting to hear this news for a couple of years now! Can’t wait to get the word about US trials…

I love Etira’s tag line, “Our mission is more than remission”! Hope abounds!

[Chamisa]

Are we sure this is Erso? I was under the impression it was a different drug. Erso (now called TEQ 103) supposedly will go to phase 1 in 2025 but isn’t there now. See oncoteq.ch/pipeline/teq103/

[13plus in reply to Chamisa]

I think you might be right. I think the Australian trial drug is similar - as in how it works against the cancer

[TammyCross in reply to 13plus]

When I was in a clinical trial for an oral SERD, there were several pharmaceuticals that were developing similar meds and they each had a different name. As it turned out, they weren't identical in their effectiveness, either. That is what I gather, because I did not have the ESR1 mutation at the time, had a complete response for one year, and then slight progression. That pharmaceutical company stopped working on it. Another one went through FDA approval, but their version works best for ESR1+.

I guess I can't generalize from the one I was on working for me without the mutation.

[Kerryd22]

It’s being trialled for other metastatic cancers too in Victoria.

Apparently it targets a wider range of ERa than Fulvestrant does. It’s said to basically detonate the target cells without harming healthy cells. The mutation is relatively common affecting an estimated 30-40% of breast cancer patients so a working, non toxic targeted drug could help thousands of patients.

All we need now is for it to trial well all the way through the three parts of the human trials!

[Jenniferp2122]

Does Anyone know how long it can take for a phase I clinical trial to eventually become FDA approved?

[awesome4ever]

Hi Jennifer. Unfortunately there is a long pathway to get from a phase 1 trial to FDA approval. Many drugs do not ever make it past phase 1. But typically it can take anywhere from 7-10 years. Most companies will use healthy subjects for their phase 1 trials as there goal is to get the best data they can in order for it to be approved to advance to the next stage. Here's a guideline on how it works. Hope this helps.

antidote.me/blog/how-long-d...