Message from the CEO

March 2009

I am pleased to report that AIM Therapeutics has continued to successfully advance its programs and activities as planned.  Our cGMP program is progressing smoothly, and our batches demonstrate robustness and scalability of the synthetic process that we developed in the first half of 2008.  We have already completed our first batch at a one kilo scale, and we’re on track to receive the second batch at a multi-kilo scale by the end of Q1 2009.   

The final studies to complete our data package to enable submission of an IND/CTA for Phase I clinical development will be completed by the end of Q2 2009.  While we had originally planned to have our data package completed by the end of 2008, this delay was largely the result of very good news: no maximum tolerated dose was found in the course of our acute toxicology (AT) studies.  The purpose of the AT studies is to define a maximum tolerated dose which is then used to design the pivotal chronic toxicology studies (14 or 28-day) required for an IND or CTA submission.  It’s very uncommon for there not to be a maximum tolerated dose, but when that happens it’s great news because it bodes extremely well for the safety profile of the drug.   

We are thrilled with the remarkable safety profile of AIM 102.  In animal studies the efficacious dose in a variety of disease models is 1-2 mg/kg by oral administration.  In our AT studies, we dosed at up to 2000 mg/kg in a 7-day study in rat with no adverse affect.  However, without a defined maximum tolerated dose, the design of the chronic toxicology studies must be very carefully considered in the context of all toxicology data balanced against manufacturing parameters, and this entails additional work and assessment.  Based on our review of these parameters, we have designed appropriate chronic toxicology studies operating at maximum feasible dose (i.e. the maximum dose that it is feasible to administer orally).  We are confident that these studies will be completed positively and with an outcome similar to the acute toxicology studies that have already been completed. 

We have also designed and completed the synthesis of a novel group of second generation compounds in AIM’s Neutropel platform, and we’re on track to have the functional data on these compounds by end of the second quarter.  We expect to find hits in this group of compounds which will greatly increase the value of AIM’s Neutropel platform. 

In addition to completing all studies as planned to be Phase I-ready by the end of Q2 2009, we are also stepping up our partnering initiatives.  Our primary goal is to identify strong potential partners and ultimately sell the Neutropel technology platform. 

To that end, AIM has attended and presented at several industry conferences including BioPharm America (Sept. 2008), BioContact (Oct. 2008), BIO-Europe (Nov. 2008), and BioPartnering (Feb. 2009).  AIM Therapeutics will also be a presenter at this year’s BioFinance conference in April 2009.  As a result of our participation at these conferences, AIM has had numerous meetings with both large and small biopharmaceutical companies regarding potential partnering opportunities. We have had very positive feedback based on our presentations and discussions regarding both the company and our technologies. 

We’re proud of the consistent progress that we’re making, and I’d like to extend sincere thanks to all of our partners and investors for their continued support.   As always, we invite you to follow our developments by signing up for our Email Alert at www.aimtherapeutics.com, or to contact us directly with any ideas or questions.