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Re: vdh1979 post# 41309

Sunday, 11/15/2009 3:38:03 PM

Sunday, November 15, 2009 3:38:03 PM

Post# of 58465
Everyday was a Black Day for GETA one time or another...lol thanks

Hi folks,

Its your lucky day I only have 13 post left today, so I'll try to make them good.

First of all I think we will be chasing GETA Monday, down or up but we will be chasing.

Restructure? Would GETA have to if the pps raised? Like to $1.20-$3.85?
Would it still be needed? Of course at .0002 it would but honestly try it for once.
Thanks

The Top 5 Most Promising Upcoming Drugs for Melanoma

Treatment of advanced (stage III and IV) melanoma is in desperate need of some good news. Although the incidence of melanoma is increasing by a whopping 3 to 5% per year in the United States, current therapies don't significantly increase survival in most patients and no new first-line medicines have been approved in over 10 years.

Clinical trials are the best hope for a long-lasting reduction or elimination of metastatic melanoma (called a "durable response" or "complete response" by doctors). The US National Institutes of Health lists 27 late-stage (phase III) clinical trials currently recruiting patients with melanoma. Many of the trials are testing new combinations of existing drugs, new ways to administer them, or new surgical procedures, but some are investigating brand new drugs. The most promising are the following:

Allovectin-7 - This novel gene therapy is injected directly into the tumors of patients with stage III or IV disease, which then alerts the body's own immune system to attack the tumor. Earlier trials of Allovectin alone showed that tumors in 4% to 9% of patients responded to the therapy. The new trial is comparing Allovectin-7 to the standard chemotherapy treatment, either dacarbazine or temzolomide. Made by Vical. Find out if you may qualify for the AIMM trial of Allovectin-7.

oblimersen (Genasense) - Genasense is a unique inhibitor of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death (called "apoptosis"). So by reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Previous studies demonstrated that Genasense combined with the chemotherapy drug dacarbazine tripled response rate and significantly increased overall survival compared to dacarbazine alone. Made by Genta. Find out more about the AGENDA trial of oblimersen.

MVax - MVax is a melanoma vaccine prepared from the patient's own cancer cells. Several studies have shown that MVax followed by interleukin-2 can lead to a complete response in up to 13% of patients, double that of interleukin-2 alone. MVax is also effective in patients with stage III melanoma when given post-surgery: it doubled the 5-year survival rate compared to surgery alone. Made by AVAX Technologies. Find out more about the MVALDI trial for MVax.

ipilimumab (MDX-010, MDX-101, or BMS-734016) - Ipilimumab is an antibody that activates the body's immune system to fight melanoma by inhibiting the CTLA-4 molecule. Three previous phase II clinical trials have shown that treatment with ipilimumab results in a one-year survival rate of 47% to 51% for people with stage III or IV melanoma, which is almost double the average. The current trial is comparing ipilimumab to a dummy treatment (placebo) in patients with stage III melanoma who have already undergone surgery. Made by Medarex and Bristol-Myers Squibb. Find out more about the EORTC 18071 trial for ipilimumab.

OncoVEXGM-CSF - OncoVEXGM-CSF is a vaccine that works by spreading within tumors and causing the death of cancer cells while stimulating the immune system to destroy metastatic tumors. Previous results from 50 patients with inoperable stage IIIc/IV melanoma demonstrated that 28% of patients responded, including 12% with a complete response. The new trial is enrolling patients with previously treated but inoperable stage IIIb, IIIc or IV melanoma and is designed to compare OncoVEXGM-CSF to a naturally-occurring substance in the body called a "granulocyte monocyte colony stimulating factor" (GM-CSF), which increases white blood cells. Made by BioVex. Find out more about the trial for OncoVEXGM-CSF.


IF THIS AGENDA FAILS, LOOK ON THE BRIGHT SIDE GETA CAN MAKE ANOTHER COCKTAIL.

BLOODY GETA ON THE ROCKS , WITH A MDX CHASER
....PLEASE

Estimated Study Completion Date: September 2014
ipilimumab (MDX-010, MDX-101, or BMS-734016
one-year survival rate of (47% to 51%) for people with stage III or IV melanoma,

Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, July 2009
First Received: March 7, 2008 Last Updated: November 4, 2009 History of

Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00636168

Purpose
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma


Condition Intervention Phase
High Risk Stage III Melanoma
Drug: ipilimumab
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
To determine whether post-operative adjuvant therapy with ipilimumab improves recurrence-free survival (RFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
To determine whether post-operative adjuvant therapy with ipilimumab improves overall survival (OS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

To determine whether post-operative adjuvant therapy with ipilimumab improves distant metastases-free survival (DMFS) as compared to placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

To compare adverse event profiles between patients receiving ipilimumab versus
patients receiving placebo [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

To compare quality of life and quality-of-life-adjusted survival between the two treatment groups (ipilimumab versus placebo) [ Time Frame: Upon occurrence ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: June 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date October 2012 (Final data collection date for primary outcome measure)


PEACE
GOOD LUCK WE ARE GOING TO NEED IT
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