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SGX201

Phase 1

Enteritis | Small molecule | Gastrointestinal |Soligenix, Inc.|Trials Updated: Dec 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

SGX201 clinical trials

SGX201 · 1 trial · 1 indication

Phase 1 1
NCT01073384A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal CancerEnteritis
COMPLETED16 Analytics
PHASE1COMPLETED
A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
EnteritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Preliminary Efficacy
One day prior to and 7 days after radiation therapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
BDP 3 mgEXPERIMENTAL1 mg TID
BDP 6 mgEXPERIMENTAL2 mg TID
BDP 9 mgEXPERIMENTAL3 mg TID
BDP 12 mgEXPERIMENTAL4 mg TID

Interventions

NameTypeDescription
SGX201 (delayed release beclomethasone 17,21-dipropionate)DRUGDelayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Primary rectal cancer * Planned course of conventional neoadjuvant radiation therapy before surgery * Scheduled to receive chemotherapy * \>/= 18 years of age * Negative pregnancy test Exclusion Criteria: * History of acute or chronic regional enteritis or inflammatory bowel...

Countries:United States
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Frequently asked questions about SGX201

What is SGX201?

SGX201 is an investigational small molecule developed by Soligenix, Inc. (ticker SNGX). It is a delayed release formulation of beclomethasone 17,21-dipropionate being studied for enteritis, a gastrointestinal condition. It has completed a Phase 1 clinical trial and is not approved for commercial use.

What is SGX201 used for?

SGX201 is being developed for enteritis, specifically for the prevention of acute enteritis in patients with rectal cancer. It is a delayed release formulation designed to deliver beclomethasone 17,21-dipropionate to the gastrointestinal tract. The program remains investigational and has completed one Phase 1 trial.

Who makes SGX201?

SGX201 is developed by Soligenix, Inc., a biopharmaceutical company that trades under the ticker symbol SNGX. Soligenix is the sponsor of the clinical program evaluating delayed release beclomethasone 17,21-dipropionate for enteritis in rectal cancer patients.

What phase is SGX201 in?

SGX201 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is SGX201 in?

SGX201 has been evaluated in one completed Phase 1 trial, NCT01073384, titled a dose ranging study of delayed release beclomethasone for prevention of acute enteritis in patients with rectal cancer. The trial enrolled 16 participants in the United States and was randomized and controlled.

Is SGX201 the same as delayed release beclomethasone 17,21-dipropionate?

Yes. SGX201 is the development code for delayed release beclomethasone 17,21-dipropionate. The two names refer to the same investigational product from Soligenix, Inc. (ticker SNGX), a small molecule formulation being studied for enteritis in rectal cancer patients.