Abbott Labs ABT-874 for Treatment of Crohn’s Disease

admin — Thu, 11 Nov 2004 19:04:27 +0000

On November 11, 2004 the results of an Abbott Labs Phase 2 Crohn’s disease clinical trial examining the safety and efficacy of ABT-874 were published in the New England Journal of Medicine. , ABT-874 is a monoclonal antibody designed to target interleukin-12 (IL-12). The authors concluded that treatment with ABT-874 may have caused clinical responses and remissions in patients with active Crohn’s disease; however, at no time were the remission rates in the ABT-874 groups significantly different from those in the placebo group. Other significant findings of note include a decrease in Th1-mediated inflammatory cytokines at the site of disease. 79 eligible patients were enrolled in this study and these participants received either ABT-874 by injection or placebo across a range of dosages and frequencies. Emerging technologies entering Phase 2 are awarded a baseline 50 efficacy points; we have are adjusted this to 40 based on our analysis of the published results.

ABT–874 is a fully human, monoclonal antibody directed against an inflammatory cytokine known as IL-12. IL-12 is a known mediator of inflammation and may be important in Crohn’s disease. Given the inflammatory nature of Crohn’s, many targets related to immune system function are being pursued. Already, approved infliximab targets the tumor necrosis factor, another member of the class of inflammatory cytokines. We have assigned ABT-874 a score of 60 for innovation status.

Crohn’s disease is a chronic, inflammatory disease of the gastrointestinal tract that affects between 500,000 and 1 million Americans. Usually diagnosed before age 30, symptoms include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases rectal bleeding. There is no cure for Crohn’s disease. Incidence estimates for this disease vary greatly, ranging from 1/100, 000 cases per year to 70/100, 000. Published studies seem to cluster around the 5-10/100, 000 range resulting in a burden of illness score of 10.

We have scored the demand/diffusion variable at 10 resulting in an overall BioHorizon Emerging Health Technology Impact Score of 30, placing ABT-874 in our Low Impact Technology category. No preliminary assessment activities are required at present.

Technology Details
Target Disease / Indication: Crohn’s Disease
Technology Classification: Drug
Body System: Gastrointestinal
Program Area: Medicine/Gastroenterology
Regulatory Status: Phase 2
BioHorizon Impact Score: 30/100 – Low

Avastin

admin — Fri, 06 Feb 2004 14:00:56 +0000

In early December 2003, Genentech announced that the Biologics License Application (BLA) for Avastin (bevacizumab) as a first line therapy in metastatic colorectal cancer had been submitted to the FDA. Genentech requested and received a ‘Priority Review’ designation. Priority Review status means that the FDA will take action on the BLA within six months of receipt of the document, which in Avastin’s case is by the end of March, 2004. Avastin inhibits the function of a protein called Vascular Endothelial Growth Factor (VEGF). Simply put, tumor cells require blood to survive, just like any normal cell in the body. VEGF plays a vital role in the ability of tumor cells to grow new blood vessels, a process called angiogenesis. In theory, inhibiting VEGF with Avastin should interfere with a tumor’s blood supply and prevent growth or spread.

The American Cancer Society estimates that 147 500 new cases of colorectal cancer will be diagnosed in the United States in 2003. This makes colorectal cancer the third most commonly diagnosed cancer and the second leading cause of cancer death in the United States.

According to Genentech, more than 2,000 patients have been treated with Avastin in clinical studies. The current BLA filing is based upon the results of a pivotal 900 patient study of Avastin plus the three other chemotherapy agents comprising the IFL regimen (5-FU/Leucovorin/CPT-11). Genentech reported that Avastin plus the IFL regimen improved median survival by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months).

Wall Street analysts position Avastin in the 1billion dollar/year sales range. The actual cost per patient treated is not known at this time but new cancer therapies typically cost somewhere in the $12 000 – $20 000 per patient per year range. It is critical to note that these costs will be in addition to the costs of treating metastatic colon cancer with existing chemotherapy regimens as, initially, Avastin will likely be used in addition to the IFL chemotherapy regimen.

If approved, we feel that Genentech’s Avastin has the potential to be a High Impact technology and therefore we recommend oncology programs begin some early assessment activities while watching for the FDA’s decision. Early steps would include the identification of current and predicted metastatic colon cancer patient numbers and some discussion with treating oncologists concerning future plans for Avastin in treatment regimens.

Technology Details
Target Disease / Indication: First Line Therapy in Metastatic Colorectal Cancer
Technology Classification: Drug
Body System: Gastrointestinal System
Program Area: Medicine/Oncology
Regulatory Status: Biologics License Application Submitted to FDA
BioHorizon Impact Score: 70/100 – High

BioHorizon » Gastrointestinal

Abbott Labs ABT-874 for Treatment of Crohn’s Disease

Avastin