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The Holder

01/31/09 12:47 PM

#5228 RE: duelittle2 #5227

Oh, I think the traders are holding some...

...and that's the reason for the higher lows. I think initially, the traders get in to flip on the runs, but even they are smart enough to know that they shouldn't get rid of all of their shares. Genta just offers way too much upside to to that.

So you see the runs, you see the sell offs, but you don't see it going back to prior lows, and you won't see that. Once you're in at these levels and start doing some DD, you'd be an ignoramus to get rid of your entire position.

That's the reason for the higher lows. Traders realize what they're holding. The more people who research the security, the higher the lows get, simply because they don't want to risk not being involved if approval comes...and from the looks of it, approval is coming.
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duelittle2

01/31/09 1:45 PM

#5235 RE: duelittle2 #5227

Tesetaxel will probably be combined with Filgrastim and or Sargramostim, which are both SQ injectables but can be taken @ Home for out patient Rx

http://www.answers.com/topic/neutropenia

http://en.wikipedia.org/wiki/Granulocyte_colony-stimulating_factor






Tesetaxel

To date, oral tesetaxel has been studied in Phase 1 and Phase 2 studies involving more than 250 patients. Objective clinical responses have been observed, no patients have developed hypersensitivity effects that have been associated with IV infusion reactions, and no patients have required pre-medication. Unlike other IV taxanes (as well as other investigational oral taxanes), tesetaxel has not been associated with serious nerve damage, which can be quite disabling. However, like all other taxanes, the most serious side-effects of tesetaxel have included lowering of the white blood cell count (neutropenia). Genta expects to conduct a series of clinical trials that will examine the efficacy and safety of tesetaxel in a range of cancer types.

http://www.genta.com/tesetaxel.html


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FDA lifts clinical hold on Genta's Tesetaxel

"Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both prototype agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).

With administration as an oral capsule, tesetaxel was developed to maintain the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.

As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that are currently in clinical development, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.

More than 250 patients worldwide have been treated with oral tesetaxel in Phase I and Phase 2 clinical trials. The major side-effect of tesetaxel in clinical trials has been myelosuppression, chiefly neutropenia. Due to the occurrence of severe neutropenia that led to fatal outcomes in several patients with advanced cancer, the drug was placed on clinical hold by FDA. Resumption of clinical trials was subject to the lifting of this clinical hold."

http://www.news-medical.net/?id=39377