Drugs / forodesine
forodesine
also known as
BCX1777 · forodesine hydrochloride · Fodosine · Forodesina · Forodesine hcl · Immucillin h · Mundesine · NSC-717904
Small molecule targets PNP via inhibition
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT00823355 | Jan 2009 → Aug 2013 | T-cell and NK-cell neoplasm | Mundipharma K.K. | Completed | No outcome recorded |
| Phase 1 | NCT00646165 | Jul 2008 → Jan 2009 | B-cell chronic lymphocytic leukemia | Mundipharma Research Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00098332 | Nov 2004 → Dec 2010 | lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00073944 | Apr 2003 → Jan 2005 | cancer | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT01776411 | Jan 2013 → Mar 2016 | peripheral T-cell lymphoma, not otherwise specified | Mundipharma K.K. | Completed | No outcome recorded |
| Phase 1/2 | NCT00742495 | Mar 2009 → Sep 2010 | T-cell acute lymphoblastic leukemia, T-cell non-Hodgkin lymphoma, precursor B-cell acute lymphoblastic leukemia | Mundipharma Research Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00289562 | Sep 2004 → Dec 2007 | B-cell acute lymphoblastic leukemia | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00061880 | Feb 2003 → Jan 2005 | lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00035022 | Aug 2001 → Mar 2004 | lymphoid leukemia, lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT00640523 | Mar 2008 → Nov 2010 | chronic lymphocytic leukemia/small lymphocytic lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00501735 | Jul 2007 → Jul 2010 | primary cutaneous T-cell lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00419081 | Jul 2006 → Mar 2007 | leukemia, lymphoma | BioCryst Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT00289549 | Jun 2005 → Jan 2009 | chronic lymphocytic leukemia/small lymphocytic lymphoma | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00095381 | Mar 2004 → Mar 2007 | T-cell leukemia | BioCryst Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2017-10-09 | BioCryst Pharmaceuticals | Results RESULTS OF CLINICAL TRIAL PROGRAM SUGGEST FODOSINE™ DEMONSTRATES CLINICAL ACTIVITY IN CERTAIN TYPES OF LEUKEMIA AND LYMPHOMA biocryst.com ↗ |
| 2017-10-09 | BioCryst Pharmaceuticals | Results DATA PRESENTED AT 2007 ASH MEETING DEMONSTRATE ACTIVITY OF FORODESINE HCL AS A SINGLE AGENT OR IN COMBINATION WITH BENDAMUSTINE IN CERTAIN TYPES OF LEUKEMIA AND LYMPHOMA biocryst.com ↗
The overall response rate for these subjects was 39%, including 2 subjects with complete response (6%) and 12 subjects with partial response (33%). |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST REVIEWS RESULTS OF BCX-1777 PHASE I STUDY IN AGGRESSIVE T-CELL MALIGNANCIES AND PROVIDES UPDATE ON CLINICAL PROGRESS biocryst.com ↗
Results of a Phase I study of intravenous BCX-1777 in aggressive T-cell malignancies were presented today at a breakfast briefing hosted by BioCryst Pharmaceuticals, Inc. in conjunction with the annual meeting of the American Society of Hematology. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports Results from Two Forodesine Oncology Studies biocryst.com ↗
Eleven of 101 (11% [95% confidence interval: 6-19%]) later stage patients enrolled achieved a partial cutaneous response, while no patients achieved a complete response. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Reports New Data from Its Phase 2 Forodesine Study in Patients with Chronic Lymphocytic Leukemia at the 52nd Annual American Society of Hematology Meeting biocryst.com ↗
An analysis conducted after all patients were followed through ≥6 months showed that six of 23 response-evaluable patients demonstrated a partial response to forodesine, resulting in a response rate of 26 percent. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES SPECIAL PROTOCOL ASSESSMENT (SPA) FROM FDA FOR PIVOTAL TRIAL OF FODOSINE™ IN T-CELL LEUKEMIA biocryst.com ↗
The SPA letter documents the agreement between FDA and BioCryst regarding the trial design's suitability to support regulatory approval. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES SPECIAL PROTOCOL ASSESSMENT FOR PIVOTAL TRIAL OF ORAL FODOSINE™ IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA biocryst.com ↗ |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES ORPHAN DRUG DESIGNATION FOR BCX-1777 IN TWO ADDITIONAL CANCER INDICATIONS biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq NM: BCRX) today announced that forodesine hydrochloride, its lead anti-cancer compound formerly known as BCX-1777 (forodesine), has been granted designation as an "Orphan Drug" for two additional cancer indications by the U.S. Food and Drug Administration (FDA). |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES ORPHAN DRUG DESIGNATION FOR BCX-1777 biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq NM: BCRX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug status to BCX-1777, the Company's purine nucleoside phosphorylase (PNP) inhibitor that is in clinical development for treatment of T-cell malignancies. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST RECEIVES FDA FAST TRACK STATUS FOR FODOSINE™ IN THE TREATMENT OF RELAPSED OR REFRACTORY T-CELL LEUKEMIA biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq NM: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" status to the development of Fodosine (forodesine hydrochloride), for the treatment of relapsed or refractory T-cell leukemia. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST PRESENTS FORODESINE CLINICAL DATA AT THE 6TH INTERNATIONAL SYMPOSIUM IN LEUKEMIA AND LYMPHOMA IN AMSTERDAM, NETHERLANDS biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that on Saturday, March 19, Dr. Shanta Bantia presented interim clinical data from the Company's Phase I trial using an oral formulation of forodesine hydrochloride (BCX-1777) for the treatment of patients with cutaneous T-cell lymphoma (CTCL), as well as interim clinical data from its Phase II trial using intravenous forodesine for the treatment of patients with T-cell leukemia. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST PHARMACEUTICALS, INC. PRESENTS PRECLINICAL RESULTS FOR BCX-1777 FOR THE TREATMENT OF T-CELL MEDIATED DISORDERS biocryst.com ↗
The study demonstrated how BCX-1777 acts by increasing intracellular deoxyguanosine triphosphate (dGTP), thus altering dNTP supply and resulting in characteristics of apoptosis. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Pharmaceuticals Continues Forodesine HCl Program in Chronic Lymphocytic Leukemia biocryst.com ↗
BioCryst Pharmaceuticals (Nasdaq: BCRX) today announced interim data from the ongoing Forodesine HCl Phase 2 program in patients with chronic lymphocytic leukemia (CLL) and data from a healthy subject pharmacokinetic and pharmacodynamic study. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BioCryst Pharmaceuticals Announces Presentation of Forodesine Data at the 45th Annual Meeting of the American Society of Clinical Oncology biocryst.com ↗
The overall response rate in the intent to treat population was 17 of 64 patients (27 percent), including 14 of 36 patients (39 percent) treated with the 80 mg/m2 dose. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PUBLICATION OF ABSTRACTS ON FORODESINE HYDROCHLORIDE AND PRESENTATION AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) biocryst.com ↗
Nine out of 13 patients had an improvement in skin and/or a pharmacodynamic response as measured by a decrease in the absolute Sezary cell numbers and/or the CD4/CD8 ratio. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PUBLICATION OF ABSTRACTS ON FODOSINE™ AND PRESENTATION AT THE 47TH ANNUAL MEETING AND EXPOSITION OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) biocryst.com ↗
The poster includes an analysis of the Phase II trial data demonstrating that intravenous Fodosine™ is active with minimal toxicity, as a single agent in relapsed or refractory T-cell leukemia. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION OF FORODESINE HYDROCHLORIDE DATA DURING THE 97TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR) biocryst.com ↗
Additionally, preliminary results of an ongoing Phase II study using oral forodesine HCL in patients with fludarabine-refractory CLL were presented. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION OF FODOSINE™ DATA DURING THE 47TH ANNUAL MEETING AND EXPOSITION OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) biocryst.com ↗
The overall response rate for these patients was 35%, including five patients with complete response (22%) and three patients with partial response (13%). |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION OF DATA DETAILING SYNERGISTIC ACTIVITY OF FORODESINE HCL WITH BENDAMUSTINE IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that data detailing the synergistic in vitro activity of forodesine HCl with bendamustine in the treatment of chronic lymphocytic leukemia (CLL) will be presented at the annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia. |
| 2017-10-09 | BioCryst Pharmaceuticals | Results BIOCRYST ANNOUNCES PRESENTATION AND UPDATE OF RESULTS WITH INTRAVENOUS FORODESINE HYDROCHLORIDE IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) AND T-CELL ALL AT THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) biocryst.com ↗
Seven of the fifteen patients treated (2 T-cell malignancies and 5 B-ALL) including five of the six treated B-ALL patients, demonstrated a hematological benefit, defined as a decrease in tumor burden. |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BioCryst Announces Mundipharma Receives Approval for Mundesine® in Japan biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that Mundipharma has obtained regulatory approval of Mundesine ® (Forodesine hydrochloride) for the treatment of relapsed/refractory PTCL (Peripheral T-Cell Lymphoma) by the Ministry of Health, Labor and Welfare in Japan . |
| 2017-10-09 | BioCryst Pharmaceuticals | Regulatory BIOCRYST ANNOUNCES FILING OF SPECIAL PROTOCOL ASSESSMENT FOR FODOSINE™ IN THE TREATMENT OF RELAPSED OR REFRACTORY T-CELL LEUKEMIA biocryst.com ↗
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of a proposed registration trial of Fodosine ™ (forodesine hydrochloride), the company's lead transition-state analog inhibitor of purine nucleoside phosphorylase (PNP). |
All press releases naming this drug 34 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Forodesine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00098332 ↗ |
| Known as | BCX1777 | “RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.” NCT00061880 ↗7“BCX1777 (forodesine), a novel purine nucleoside phosphorylase inhibitor, induces apoptosis, mainly in T cells.” PMID 22448814 ↗ Apr 2012 “Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth.” NCT00098332 ↗ “Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma” NCT00501735 ↗ “forodesine hydrochloride (BCX-1777)” NCT00289549 ↗ “forodesine hydrochloride (BCX-1777)” NCT00095381 ↗ “forodesine hydrochloride (BCX-1777)” NCT00289562 ↗ |
| Known as | Fodosine | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Known as | Forodesina | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Known as | Forodesine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Known as | forodesine hydrochloride | “Forodesine Hydrochloride Sterile Solution, 5 mg/mL” NCT00419081 ↗4“forodesine hydrochloride (BCX-1777)” NCT00095381 ↗ “forodesine hydrochloride (BCX-1777)” NCT00289549 ↗ “forodesine hydrochloride (BCX-1777)” NCT00289562 ↗ “Drug: forodesine hydrochloride” NCT00823355 ↗ |
| Known as | Immucillin h | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Known as | Mundesine | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Known as | NSC-717904 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218291 ↗ |
| Action | Inhibit | “BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor” NCT00035022 ↗ |
| Modality | Small molecule | — CHEMBL218291 ↗ |
| Route | Intravenous | “intravenous BCX-1777” NCT00035022 ↗ |
| Target | PNP | “Forodesine is a new and potent purine nucleoside phosphorylase (PNP) inhibitor.” PMID 20427701 ↗ Apr 2010 |