Transcription of The Stock Network Interview with Imagion Biosystems (ASX:IBX), Chair Bob Proulx
Lel Smits: Imagium Biosystems is advancing a new approach to cancer detection with MagSense, its non-radioactive bio-safe molecular MRI imaging agent designed to help clinicians detect cancer earlier and with greater precision.Imagion Imagium Biosystems is initially focused on HER2 plus breast cancer using magnetic nanoparticles to identify cancer through advanced MRI imaging and now processing the MagSense HER2 imaging agent phase 1b2 clinical trial towards patient enrolment. With key contract research organisation work orders signed, investigational product manufacturing complete and discussions with seven prospective US clinical trial sites in process, Imagium Biosystems chair Bob Proulx joins me to discuss how the company is moving through critical steps required to launch the study.
Bob, welcome to the Stock Network.
Bob Proulx: Great, nice to be here, thanks for the invitation.
Lel Smits: Now, in terms of preparing for the start of the phase 2 trial, what are the key activities that need to be accomplished before the MagSense HER2 phase 1b2 clinical trial can begin?
Bob Proulx: Yeah, that’s a bit of a mouthful, isn’t it? Well, first and foremost, we need to get the first couple, one or two sites under contract.
And, you know, it sounds easy, but there’s a lot involved in that. You know, unlike in Australia, where in fact, I give a lot of credit to the organisations and the government in Australia for streamlining and centralising a lot of the clinical and regulatory processes necessary to do a clinical study. In the United States, each site often has their own research committees and ethics review committees that have to approve the site’s participation before you can even get into the contract.
So, there’s a lot of administrative hurdles involved here that even though we went through the big hurdle of getting clearance from the FDA on our investigational study, each site really has its own process that we have to follow. So, we’re in that mode right now where we’re trying to get the first couple of sites under contract so we can then go ahead and get started with those. And, you know, one of the difficulties here is that these are the institutions that we want to work with are busy hospitals treating patients.
And so, we have to work with their timelines, not necessarily our timelines. But at this point in time, we know we have multiple sites that are keen to work with us and we’re trying to work through that process as expeditiously as possible right now.
Lel Smits: Excellent. And Bob, once a site is activated, what remains to open the study for enrolment?
Bob Proulx: Yeah, so that’s the administrative side of things that I just described. Then, once you have the site under contract and ready to go from a paperwork perspective, you still then have to go through and there’s a lot of training involved, right? We need to be able to make sure that everyone who’s participating at that site, from the medical oncologists and the radiologists and the people involved in pathology, that they all really understand the study and what their role is and that they know how to enter the data into the database for any participants. And even down to helping them make sure they understand the recruitment process, what kinds of participants are we looking for, etc.
So, the big thing really is once we get the site under contract is to then complete the training and then they can begin enrolment of patients. And finally, with seven prospective US sites being considered, what are your expectations for the near term? Yeah, so since the IND was cleared, we’ve been dealing primarily with these administrative aspects and so there hasn’t been a lot of news flow to report. But as we’ve said, we’ve got multiple sites, as you just said, you know, I think we have seven sites that are trying to move through the process.
And so, with everything else that’s in place, we have the investigational product ready, the database is now just about completed, the training manuals are being finalized. I think we’ll be on track now to go ahead and get the study open and start recruiting patients here in the near term. That’s what we’re looking for the most, is to get that first site under contract, the training done, and then just start to open the study for enrolment.
Lel Smits: Bob, thank you for the update on Imagium Biosystems and look forward to hearing more soon.
Bob Proulx: Thanks very much, appreciate it.
Ends