FDA DENIES IPLEX USAGE FOR ALS

November 7, 2008, Genetech, Tercica, Ipsen and Insmed reach agreement to release IPLEX to ALS patients.

In early December, 2008, eight ALS patient families submitted IND/IRB applications to the FDA, following the procedure as directed by Insmed and the FDA.

On January 16, all were notified by phone by the FDA that their IND’s had been rejected/denied on grounds of ‘unsubstantiated claims of higher mortality’ and ‘excessive blogger interest in Iplex’. Written FDA notification received January 28 confirmed that ‘there has been a suggestion of an increase in patients randomized to IGF-1 compared to patients randomized to placebo in several studies.’ Note the FDA refers to IGF-1 (Myotrophin) and not IGF-1/IGF-bp3 (Iplex). Extensive materials exist that refute FDA assertions.

The FDA complaint/rationale for why not to approve Iplex appears to be “the intense interest in this compound in the ALS community”, an argument based on FDA concerns that the use of Iplex “would expose patients to potentially serious risk without any possibility of learning whether the treatment was effective”. This argument begs the question of the more imminent dangers of death and further physical disrepair to those with ALS left untreated by any effective medication.

ALS WORLDWIDE currently holds many IND/IRB applications until assurances have been reached that they will not be rejected out of hand for the reasons stated above.

We are mobilizing as many resources as possible in order to overcome this decision by the FDA. These resources include, but are not limited to, those within the biotech and conventional pharmaceutical industries, media, legal assistance, National Institutes of Health (NIH), FDA, legislators, judiciary and others.

Appeals are underway. Your help is essential.

Contact your legislator, media and others to make our cause known to those who can ‘make a difference.’ Email Lorie Walker at loriewalker@alsworldwide.org. to request our documented and detailed explanation of Iplex and the present difficulties those with ALS currently face. You will receive, via email, a cover letter and all relevant attachments which can easily be forwarded. On behalf of the ALS community, thank you for your participation and assistance.