From: "Dr. D. Kossove" <doctordee@telkomsa.net>
To: <Ropeipert@aol.com>
Subject: l glutamine
Date: Thursday, January 01, 2004 11:31 AM

http://www.asco.org/ac/1,1003,_12-002489-00_18-002003-00_19-00104446-00_28-00RESULTPAGE,00.asp

Year:   2003  Printer Friendly  
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Category:   Patient Care  
SubCategory:   Supportive Care  
 
 
 
Phase III study: AES-14 in chemotherapy patients at risk for mucositis  
Abstract No: 2917 
Citation: Proc Am Soc Clin Oncol 22: page 725, 2003 (abstr 2917) 
Author(s): D. E. Peterson, R. G. Petit; Univ Conn Hlth Ctr, Farmington, CT; Aesgen Inc., Princeton, NJ 
Abstract: Cancer chemotherapy-induced oral mucositis can be a frequent toxicity resulting in considerable morbidity and health care cost. New mechanistic models have permitted targeted interventions directed to prevention or treatment. AES-14 is a novel drug delivery system designed to concentrate delivery of L-glutamine to oral mucosa at risk for ulceration. In this study, 121 patients at risk for mucositis were randomized to AES-14 or placebo during one cycle in a multicenter placebo-controlled study. Predicted severity of mucositis was based on initial treatment with a mucotoxic regimen or a repeat cycle of chemotherapy that previously caused mucositis. Treatment groups were comparable relative to baseline demographics. AES-14 was administered topically/enterally in 8ml doses BID from day 1 of chemotherapy until 2 weeks after last chemotherapy dose, or oral mucositis resolution. Oral mucositis was scored via two scales (NCI-CTC; Oral Mucositis Assessment Scale). Two-tailed statistical tests were principally used. In patients with previous history of mucositis, incidence of > Grade 2 oral mucositis was considerably less in AES-14 patients (38.1%) than with placebo (58.8%). No AES-14 patients experienced grade 3 or 4 mucositis vs. 11.8% of placebo. Grade 2 mucositis occurred less frequently than with placebo (38.1% AES-14 vs. 47.1% placebo). More AES-14 patients had no mucositis (Grade 0) than placebo (33.3% AES-14 vs. 23.5% placebo). In the ITT population, incidence of > Grade 2 mucositis was 46.8% in the A E S-14 group and 50.7% in placebo. AES-14 treatment was not associated with side effects. The data suggest a potential 20% reduction in expression of moderate-severe mucositis with AES-14, as well as a 10% increase in Grade 0 mucositis. This study was closed early by the sponsor to initiate a more efficient replacement study focusing on patients with prior mucositis history who will be receiving additional mucotoxic chemotherapy. A goal of this new research is to more clearly demonstrate treatment effects and minimize variability across patients and treatments. Supported by Aesgen Inc. 
 
Associated Presentation(s): 
 
1.  Phase III Study; AES-14 in Chemotherapy Patients at Risk for Mucositis 
Year: 2003 
Presenter: Douglas E Peterson, PhD
Session: Pathogenesis-Based Treatment of Mucositis and Nausea and Vomiting (Education Program) 
    

 





Date:    Wed, 17 Dec 2003 11:42:13 EST
From:    Rosalie Peipert <Ropeipert@AOL.COM>
Subject: New Treatment for chemo mucositis

Saforis(TM), a product of Princeton-based Aesgen Inc., is an oral
suspension
currently in Phase III clinical trials for oral mucositis. A common
and
painful side effect of chemotherapy treatments, oral mucositis is
damage to the
lining of the throat and mouth . damage that can become so severe that
patients
may have trouble eating and drinking. Saforis(TM) recently received
fast-track
status from the FDA.
> http://tinyurl.com/zniy  "In its [L-glutamine's] native form, we
faced some
> challenges at the molecular level," explained Dr. Douglas E.
Peterson during
> a May 31, 2003 American Society of Clinical Oncology (ASCO)
presentation
> titled "Phase III Study: AES-14 in Chemotherapy Patients at Risk for
Mucositis..
> Dr. Peterson reported that L- glutamine is poorly soluble,
chemically labile
> and is rapidly metabolized. Until now, delivery of L-glutamine to
oral
> mucosa at therapeutically effective levels had not been proven
possible
>     Click here: MyCancerCompass - Public Page

Just wanted to say that because I have celiac disease, I take capsules
of
L-glutamine with each meal to keep healing my intestines from damages
from being
undiagnosed for so many years. It does help.
Rosalie
22 yr survivor, stage IV for 11 years TODAY.

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