Genta, Inc (fka GNTAQ)

[The Holder]

Genta is currently working with the FDA on two major projects, with respect to Genasense (there are certainly other applications in ongoing trials, as I listed in prior posts...other major Pharma's using Genta (oblimersen).

1) Genasense + Chemotherapy in the treatment of CLL: This was the last NDA that received a non-approvable in early December. The price didn't start it's collapse until 6 days AFTER the announcement of non-approvable was made. You figure that one out, I haven't. I believe it was shorted and panic selling began. The FDA said that for CLL, more data was needed and that the NDA wasn't approvable "in its current form". Genta leadership felt strongly that the drug showed both efficacy and safety and submitted the appeal a week or 2 later (after the price had fallen hard). They said that they were going to meet with FDA leadership to understand the key issues to get them squared away. That is ONE effort of Genasense.

Now the 2nd:

2) Genasense + Chemotherapy as a treatment of melanoma: This is the AGENDA trial, it's separate from CLL and treats a completely different form of cancer. This NDA has been submitted a few times and has been given a few different reasons for non-approval. A while back, it was "need more data". Most recently, it was that there may have been bias in the analysis that produced the results. Genta is tackling these problems by doing 2 things. 1) Conducting a very large scale, world-wide, double-blind, randomized, placebo driven study named Agenda. Not only are they doing this, but they are having an INDEPENDENT analyst group report the results of the trial using the FDA's specified and requested method. So far, the results of the Agenda trial are flat out undeniable. The FDA will now have a plethora of world-wide, completely unbiased data, and completely unbiased analytical results. The update from the Agenda Phase III trial released in January got a rise out of investors (you can look at the charts) because they were very, very positive. I've linked the interim results, released in January 2009, in an image below.

http://i121.photobucket.com/albums/o207/AHummell/gen.png?t=1233716531

There is an appeal in from Genta to the FDA on their non-approvable decision on Genasense + Chemotherapy for the treatment of CLL. There is a completely separate trial of Genasense and it's treatment of Melanoma, the Agenda Phase III trial, which is producing great results.

These 2 things, along with the recent patents and orphan drug status approvals, are what is driving this stock. The pipeline is innovative and solid. Pair that with the Genta CEO sitting on the panel of the 2009 BIO CEO & Investors Conference coming up on Monday and Tuesday and you can quickly start to see why we're seeing such great performance out of Genta.

If investors are there to finance and invest in a drug company with innovative products, boasting proven results, at a cheap price...well, there are few better Biotech companies at this time than Genta.

It could get very interesting next week. Monday and Tuesday will be great for investors to hear an update on the two applications mentioned above, as well as other groundbreaking drugs in the pipeline for Genta. Here's a link for the webcast.

http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=GNTA&item_id=2079510