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Biotech / Medical : ProMetic Life Sciences -- Ignore unavailable to you. Want to Upgrade?


To: Cush who wrote (159)12/19/2017 1:35:39 PM
From: axial1 Recommendation

Recommended By
The Ox

  Read Replies (1) | Respond to of 250
 
Hi Cush — Sometime soon, we should discuss off-label uses for PBI-4050 and Ryplazim. To avoid the perception of pumping I've avoided the subject: still speculative. However readers should be aware of the enormous potential.

In the meantime, it appears that Prometic is a testing a combined attack on fibrosis, particularly in the lungs.

Does this morning's PR about orphan status for PG to treat IPF mean that PLI is now looking at a two prong attack on IPF using both PG AND 4050 to treat IPF? This sounds new to me. Has this new approach been made public before?
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Fred responded as follows:

Hi .......,

This is indeed new info for the public. We have been waiting for a while for the orphan drug designation and finally received it.

If demonstrated efficacious in IPF, plasminogen would be used in IPF patients that are undergoing Acute exacerbations…just like patients with Acute Lung Injury…
In other words, plasminogen would be used in the Hospitals / ICUs whilst PBI-4050 would be chronic / once daily therapy.

When we say that “we are the company that can effectively address the entire healing process in a ground-breaking way using both small molecule drugs and plasma protein therapies…” this is not a joke, we really do have a deep understanding of the healing process…

Cheers,

Fred
Frederic Dumais
Directeur principal, Communications et relations avec les investisseurs, Senior Director, Communications and Investor Relations
440 Boul. Armand-Frappier
Laval, Quebec H7V 4B4
+1 450 781 0115
f.dumais@prometic.com
____________________________________________

Jim



To: Cush who wrote (159)12/20/2017 1:28:57 PM
From: axial1 Recommendation

Recommended By
Cush

  Respond to of 250
 
Followup — No content changed. Edited for clarity.

A few questions on latest PR
.
  • 1) Of IPF population, how many will experience AE-IPF ( %):
— Excellent question. Some studies refer to approximately 15 % of IPF patients will experience acute exacerbation episodes within a year of diagnosis while other studies refer to as much as 20% will experience within 3 years. It is significant enough to represent an unmet medical need.
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  • 2) In previous mail to SH you mention: "This is indeed new info for the public. We have been waiting for a while for the orphan drug designation and finally received it. When was the designation asked for? Couple of months ago…."
Do you have a trial protocol established as J. Moran clearly states your intent to trial PG on AE-IPF?

— Working on it as we speak
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  • What would be the design/timeline of such trial considering PG most likely will be FDA approved before trial start?
— Too early to confirm at this point in time. Will it be a simple PK trial demonstrating that we can replenish the plasminogen level of a patient known to be deficient because of an acute episode or will we need to go for more specific endpoint? We will know after discussing with the regulatory authority but I’m not in position to provide info on this at the moment.
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  • With an 85% survival rate (**should read: mortality rate: see original corrected) and few months average survival time, we should be looking at a relatively short trial. What are your expectations on duration of trial?
— I would indeed think that this would not require a long trial. It may even be as simple as by how much time are you cutting down hospitalization time during these acute episodes…again, we will know a lot more once we will have had the opportunity to sit down with the regulatory authority to discuss.

Jim