Andromedia's DiaPep 277 Preps for Second Phase-III Trial

I had previously posted an update to Andromedia's DiaPep 227, but that post was based on a misunderstanding of the FDA (and EU) approval process.  This post is a correction to my Monday, November 23, 2009 posting about DiaPep 227.  I'm very sorry for my previous mistake.

Note: Andromedia press releases refer to both DiaPep 227 and DiaPep 277 interchangeably (I think).  This is not a typo.  Their own press release page (link below) contains more than one press release where the headline refers to one number while the text refers to the other.  I'm not sure what  is going on, but I'm assuming that there is only one drug.  I'm using the tag DiaPep 277 from now on in my blog, but in the past I've used both.  It's very confusing! 

Andromedia's DiaPep 277 Preps for Second Phase-III Trial

Andromedia recently announced their plan to move DiaPep 227 into market availability which was approved by EMEA.  EMEA is the European Union's version of the USA's FDA. This will include doing a second phase-III trial after they finish their current phase-III trial (which expected in 2011). This second phase-III study will be large (450 people) and multi-site (100 locations in Europe).

DiaPep 277 is described by Andromedia this way: "a synthetic peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide modulates the immune system that leads to autoimmune diabetes by diminishing or blocking the destruction of beta cells by the immune system."  So this treatment is similar to the other ones currently in phase-III trials in that it is designed to preserve beta cells that have not yet been destroyed by the autoimmune attack in honeymoon stage diabetes.

DiaPep 277 has been in a phase-III trial for many years.  It was the first company that I know of to start one for a cure for type-1 diabetes (honeymoon only, unfortunately).  The EMEA (much like the FDA) requires two studies to show safety and effectiveness of new treatments.  Sometimes the two studies are a phase-II study and a phase-III study, but usually, two different phase-III studies are required.  Obviously, pharma companies would prefer to do the two phase-III trials at the same time so they get to market quicker, but sometimes they are done one after the other.  That is the case for DiaPep 277 the first phase-III study will be almost done (or done) by the time the second one starts.

Previously, DiaPep 227 was in the lead in terms of finishing their first phase-III trial.  However, the more important milestone is when they complete their second phase-III trial, and it now looks like they will be behind Diamyd, ToleRx, and MacroGenics.  I think Andromedia is 3-5 years away from market approval and that is assuming that their first phase-III trial has good results, and their second phase-III trial works as they hope.  These are both big assumptions.

Their new clinical trial does not have a clinicaltrials record yet, but it will be for honeymoon diabetes only.

Press release:
http://www.pharmpro.com/ShowPR~PUBCODE~021~ACCT~0000100~ISSUE~0911~RELTYPE~IN~PRODCODE~0000~PRODLETT~NB.html
All corporate press releases: http://www.andromedabio.com/news.aspx

Previous blogging on DiaPep277:
http://cureresearch4type1diabetes.blogspot.com/search/label/DiaPep%20277

Clinical trial sites for the three studies on  DiaPep 277 that I can find:
http://www.clinicaltrials.gov/ct2/show/NCT00644501
http://www.clinicaltrials.gov/ct2/show/NCT00615264
http://www.clinicaltrials.gov/ct2/show/NCT00058981

I would like to thank bellow bravebuddy member Dave for his insight into the FDA approval process, and also for providing me the link to the FDA "guidance document", which you can read here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078749.pdf

Joshua Levy

All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.