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Forodesine

Phase 2

Cutaneous T-cell Lymphoma (CTCL), | Small molecule | Oncology |BioCryst Pharmaceuticals, Inc.|Last Updated: Jul 10, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment144

FDA Designations

No designations recorded

Clinical trial landscape

Forodesine · 8 trials · 7 indications

Phase 2 4Phase 1 4
NCT00640523Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia (CLL)
COMPLETED23 Analytics
NCT00501735Forodesine in the Treatment of Cutaneous T-Cell LymphomaCutaneous T-cell Lymphoma (CTCL),
COMPLETED144 Analytics
NCT00289549Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, Chronic
COMPLETED8 Analytics
NCT00095381Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell LeukemiaLeukemia, T-Cell
COMPLETED20 Analytics
PHASE2COMPLETED
Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia (CLL)Unlock trial analytics
PHASE2COMPLETED
Forodesine in the Treatment of Cutaneous T-Cell Lymphoma
Cutaneous T-cell Lymphoma (CTCL),Unlock trial analytics
PHASE2COMPLETED
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Leukemia, Lymphocytic, ChronicUnlock trial analytics
PHASE2COMPLETED
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
Leukemia, T-CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall response rate
Up to 6 cycles of therapy
The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.
Duration of Study
Response rate after 2 cyclesof forodesine therapy.
8 weeks
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)

Secondary Endpoints

Safety and tolerability
Duration of Study
Time to and duration of objective response in cutaneous manifestations
Duration of Study
Time to loss of objective response
Duration of Study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
forodesine HClDRUG2 x 100mg capsules daily
Forodesine 200 mgDRUG2 x 100mg tablets once daily
forodesine hydrochloride (BCX-1777)DRUGexperimental, forodesine oral dose 200 mg administered daily.
forodesine hydrochlorideDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Age 18 years and older 2. Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria. 3. Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -...

Countries:United StatesAustraliaAustriaFinlandFranceGermanyItalySpainSwitzerlandUnited KingdomGeorgia
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "Cutaneous T-cell Lymphoma (CTCL),")

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Frequently asked questions about Forodesine

What is Forodesine used for?

Forodesine is an investigational small molecule being studied for the treatment of several blood cancers, including cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL), B-cell acute lymphoblastic leukemia, and T-cell leukemia. It is being developed by BioCryst Pharmaceuticals, Inc. (BCRX) and is currently in Phase 2 clinical development.

How does Forodesine work?

Forodesine is a small molecule that targets the enzyme purine nucleoside phosphorylase (PNP). By inhibiting PNP, it disrupts purine metabolism, leading to the accumulation of toxic metabolites that induce apoptosis in malignant T-cells. This mechanism is being investigated for its potential to treat T-cell malignancies such as CTCL and T-cell leukemia.

Who is developing Forodesine?

Forodesine is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various hematologic malignancies.

What phase is Forodesine in?

Forodesine is currently in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in cutaneous T-cell lymphoma (CTCL) and chronic lymphocytic leukemia (CLL). The drug is not yet approved by the FDA and remains investigational.

What clinical trials has Forodesine been in?

Forodesine has been evaluated in several completed clinical trials, including NCT00073944 (Phase 1 in refractory cancer), NCT00095381 (Phase 2 in advanced T-cell leukemia), NCT00501735 (Phase 2 in cutaneous T-cell lymphoma), and NCT00640523 (Phase 2 in chronic lymphocytic leukemia). These trials enrolled a total of 144 patients across multiple countries.

Is Forodesine the same as BCX-1777?

Yes, Forodesine is also known as BCX-1777. In clinical trials, it has been referred to as forodesine hydrochloride (BCX-1777), particularly in earlier studies such as NCT00073944 and NCT00095381. This alternative name is used interchangeably in the literature and trial registrations.