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Upamostat - Link Health Group/RedHill Biopharma

Drug Profile

Upamostat - Link Health Group/RedHill Biopharma

Alternative Names: Mesupron; RHB-107; WX-671

Latest Information Update: 22 Apr 2020

At a glance

  • Originator Wilex
  • Developer Heidelberg Pharma AG; Link Health Group; RedHill Biopharma; WILEX AG
  • Class Amines; Antineoplastics; Antivirals; Imides; Piperazines; Small molecules; Sulfonamides
  • Mechanism of Action Serine endopeptidase inhibitors; Urokinase-type plasminogen activator inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Breast cancer; Pancreatic cancer
  • Clinical Phase Unknown Cancer; Gastrointestinal disorders
  • Preclinical COVID 2019 infections; Solid tumours
  • Discontinued Head and neck cancer

Most Recent Events

  • 20 Apr 2020 RedHill Biopharma and National Institute of Allergy and Infectious Diseases agree to co-develop upamostat for COVID-2019 infections
  • 13 Mar 2020 Preclinical trials in COVID-2019 infections in Israel (PO)
  • 13 Mar 2020 RedHill Biopharma plans a phase II trial for Cholangiocarcinoma (Inoperable/Unresectable, Late-stage disease, Combination therapy, Second-line therapy or greater) in USA

Development Overview

Introduction

Upamostat is a second-generation serine protease inhibitor is being developed by RedHill Biopharma and Link Health Group, for the oral treatment of multiple cancers, COVID-2019 infections and gastrointestinal disorders. Upamostat was discovered and originally developed by Wilex (now Heidelberg Pharma AG). The compound has since been licensed to RedHill Biopharma and Link Health Group. It also targets the urokinase plasminogen activator (uPA) system, and is a small molecule pro-drug of WX UK1 [see Adis Insight Drug profile 800012176]. The uPA system, an extracellular protease enzyme system, is over-expressed on certain tumours, and plays a major role in primary tumour growth and metastasis. When uPA binds to its receptor (uPAR), plasminogen is converted to plasmin, which degrades the extracellular matrix enabling the tumour to invade surrounding healthy tissues. Upamostat presents a promising new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit both tumour metastasis and growth. The preclinical data and literature also indicates anti-viral activity of the molecule. Clinical development as a combination therapy for breast cancer, pancreatic cancer and cancers is ongoing worldwide. Clinical development is ongoing for gastrointestinal disorders. Preclinical development for COVID-2019 infections is underway in Israel.

Phase I development as monotherapy was underway in Germany. According to the Wilex pipeline as of March 2013, upamostat is no longer being developed in head and neck cancer.

In October 2017, WILEX AG changed its name to Heidelberg Pharma AG [1] .

Company Agreements

In April 2020, RedHill Biopharma and National Institute of Allergy and Infectious Diseases entered into a research and development agreement to evaluate upamostat in non-clinical studies for COVID-2019 infections. [2]

In March 2014, WILEX AG entered into a licensing and development partnership for MESUPRON® with Link Health Co. Link Health will receive the exclusive licensing rights for the development and marketing of MESUPRON® in China, Hong Kong, Taiwan and Macao. Link Health will be responsible for performing and financing the entire clinical development of MESUPRON® in China in all oncological indications, including HER2-negative metastatic breast cancer and non-metastatic pancreatic cancer, as well as for the regulatory process and product marketing. Under the agreement, WILEX will receive a signing fee and milestone payments totalling more than 7 million Euro during clinical development in the first four indications to be developed by Link Health as well as staggered medium single digit royalties. In April 2016, Wilex received a milestone payment of approximately €500 000 after submission of IND. In January 2019, Heidelberg Pharma received milestone payment from Link Health following approval of the Chinese National Medical Product Administration (NMPA) to conduct clinical trials with the product candidate MESUPRON®. [3] [4] [5]

In June 2014, Wilex entered into an exclusive licensing agreement with RedHill Biopharma, under which the latter acquired the development and commercialisation rights to upamostat (MESUPRON®) for all indications in regions outside of China, Hong Kong, Taiwan and Macau. Wilex received an upfront payment of $US1 million and tiered royalties on net revenues, that may range from mid-teens upto 30%. RedHill Biopharma will be responsible for undertaking clinical trials, regulatory procedures and commercialisation of upamostat. [6] [7]

In January 2017, RedHill Biopharma entered into a research agreement with Aarhus University, for the identification and further evaluation of additional high affinity molecular targets of upamostat, that may aid in optimal selection of patient sub-population for treatment efficacy in planned studies. The organisations, under a previous collaboration, elucidated on the structure activity relationships between upamostat's active metabolite, UK-1, and proteases [8] .

Key Development Milestones

Breast cancer

First-line therapy with upamostat in combination with capecitabine was well tolerated and increased progression free survival and objective tumour response compared with capecitabine alone in a phase II trial in 132 patients with HER2-receptor negative metastatic breast cancer (NCT00615940; EudraCT2007-006078-27) [9] [10] . The trial was conducted in the US, Brazil, Israel, Belgium and Germany, and was completed in April 2012 [11] [12] [13] . Wilex reported in its half-yearly report for 2013 that its partnering process was based on positive data from this trial [14] .

Head and neck cancer

In September 2007, Wilex completed a phase Ib study of upamostat monotherapy in patients with head and neck cancer, prior to surgical resection [15] . The study included 18 patients and was conducted in Germany. The double-blind, placebo-controlled study examined multiple escalating doses of the agent, and trial results have been reported [16] [17] . However, according to the company's pipeline as of March 2013, the compound is no longer being developed in this indication.

Pancreatic cancer

In October 2017, the US FDA granted the orphan drug designation to upamostat (MESUPRON) as an adjuvant treatment of pancreatic cancer [18] .

Wilex has completed a phase II trial of upamostat, in combination with gemcitabine, in patients with locally advanced, inoperable, non-metastatic pancreatic cancer (NCT00499265; EudraCT2006-005314-12) [19] . In this open-label trial, patients were randomised to receive upamostat at 200 or 400 mg, once-daily, plus gemcitabine, or gemcitabine alone. The final analysis confirms the preliminary data which demonstrated improvements in tumour response and an increase in overall survival in the upamostat treatment groups. A total of 95 patients were enrolled in Germany, Italy, Hungary, Spain, Russia and the Ukraine [20] [21] [22] [23] [24] [14] .

Solid tumours

In January 2016, Link Health submitted an IND application to the China Food and Drug Administration to initiate a phase I dose escalation trial of upamostat in patients with solid tumours. The open-label trial will assess the safety, efficacy, pharmacokinetics and pharmacodynamics of upamostat in Chinese patients. Once the biologically effective dose is confirmed, the company plans to initiate two phase II trials in cancer patients [25] [26] . As of December 2018, the Chinese National Medical Product Administration (NMPA) approved conduct of clinical trials (phase I and phase II trials) in China. Link Health intends to conduct phase II trial, after revising the clinical study protocol due to new regulatory situation [27] [28] [5] .

Wilex completed an open-label, single dose-escalating phase I study in July 2005, which investigated upamostat at four dose levels in 16 healthy male volunteers [29] [30] .

RedHill reported in March 2016, that non-clinical studies to further investigate the mechanism of action and define the patient population for upamostat are ongoing. Based on positive results of these studies the company intends to launch a phase II clinical trial in cancer in 2017. The study results are anticipated to support the clinical data from previous phase I and phase II studies with upamostat [31] [32] .

Gastrointestinal disorders

Clinical development is underway for inflammatory gastrointestinal disorders (RedHill Biopharma pipeline, August 2018) [33] .

COVID-2019 infections

In March 2020, RedHill Biopharma reported that based on pre-clinical data and literature indicating potential anti-viral activity, the company is actively pursuing an exploratory program intended to investigate the activity of opaganib and upamostat [see Adis Insight Drug Profile [500021537]], individually and in combination with hydroxychloroquine and other compounds in the treatment of COVID-2019 (novel coronavirus) [34] .

In non-clinical studies conducted by Aarhus University, molecular targets, including multiple proteases, were identified that may demonstrate higher sensitivity to upamostat, compared with urokinase plasminogen activator (uPA). Evaluation of these targets may aid in selection of patient population that would benefit with upamostat treatment in planned studies [8] .

Patent Information

In September 2017, RedHill Biopharma received a notice of allowance from the USPTO regarding a patent to upamostat and Yeliva® [see Adis Insight profile 800019263], covering the use of proprietary investigational compounds in combination with a known antibiotic. The patent covers combination for the potential treatment of cancer, prevention of cancer recurrence or progression and inhibition of growth and proliferation of cancer cells [35] .

Upamostat is covered by several issued and pending patents worldwide, including crystalline modifications of N- a -(2,4,6-triisopropylphenylsulfonyl)-3-hydroxyamidino-(L)-phenylalanine 4-ethoxycarbonylpiperazide or salts, which can be used as pharmaceutical agents, pharmaceutical uses comprising these novel crystalline modifications; urokinase inhibitor compounds; methods for the production of phenylalanine derivatives and method of preparing methylhydroxyalkylcellulose, which are expected to expire in between 2018 and 2026. This patent portfolio was in-licensed by RedHill Biopharma from Wilex (RedHill Biopharma 10-K February 2015).

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Capsule, unspecified
  • Class Amines, Antineoplastics, Antivirals, Imides, Piperazines, Small molecules, Sulfonamides
  • Target Serine endopeptidase; Urokinase-type plasminogen activator
  • Mechanism of Action Serine endopeptidase inhibitors; Urokinase-type plasminogen activator inhibitors
  • WHO ATC code

    A03 (Drugs for Functional Gastrointestinal Disorders)

    J05 (Antivirals for Systemic Use)

    L01X (Other Antineoplastic Agents)

  • EPhMRA code

    A3 (Functional Gastro-Intestinal Disorder Drugs)

    J5 (Antivirals for Systemic Use)

    L1X9 (All other antineoplastics)

  • Chemical name ethyl 4-{(2S)-3-{3-[(E)-N'-hydroxycarbamimidoyl]phenyl}-2-[2,3,5-tri(propan-2-yl)benzenesulfonamido]propanoyl}piperazine-1-carboxylate
  • Molecular formula C32 H47 N5 O6 S
  • SMILES N1(CCN(CC1)C(C(CC1C=C(C=CC=1)C(N)=NO)NS(=O)(=O)C1=C(C=C(C=C1C(C)C)C(C)C)C(C)C)=O)C(=O)OCC
  • Chemical Structure
  • CAS Registry Number 1191101-18-4

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Breast cancer In combination with capecitabine Combination therapy, First-line therapy, Metastatic disease Phase II Belgium, Brazil, Germany, Israel, USA PO / Capsule Heidelberg Pharma AG 31 Jul 2008
COVID 2019 infections - - Preclinical Israel PO / unspecified RedHill Biopharma 13 Mar 2020
Cancer - Combination therapy Clinical Phase Unknown USA PO / Capsule RedHill Biopharma 18 Sep 2017
Gastrointestinal disorders - - Clinical Phase Unknown Unknown PO / unspecified RedHill Biopharma 01 Aug 2018
Head and neck cancer - Monotherapy Discontinued (I) Germany PO / Capsule WILEX AG 06 Mar 2013
Pancreatic cancer In combination with gemcitabine Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease Phase II Germany, Hungary, Italy, Russia, Spain, Ukraine PO / Capsule Heidelberg Pharma AG 09 Nov 2007
Solid tumours - - Preclinical China PO / Capsule Heidelberg Pharma AG, Link Health Group 01 Jan 2019

Orphan Status

Indication Patient Segment Country Organisation Event Date
Pancreatic cancer Adjuvant therapy USA RedHill Biopharma 20 Oct 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Wilex Originator Germany
Heidelberg Pharma AG Owner Germany
Link Health Group Licensee China, Hong Kong, Macau, Taiwan
RedHill Biopharma Licensee World
Aarhus Universitetshospital Collaborator Denmark
National Institute of Allergy and Infectious Diseases Collaborator USA

Brand Names

Brand Name Organisations Indications Countries
Mesupron Heidelberg Pharma AG Pancreatic cancer World

Scientific Summary

Pharmacokinetics

There were no drug-drug interactions in a phase II trial of combination therapy with upamostat and capecitabine in 132 patients with HER2-receptor negative metastatic breast cancer [9] [10] .

Upamostat (the prodrug) showed good oral bioavailability and conversion into the active drug WX UK1, when administered at multiple escalating doses in healthy male volunteers, in a phase I, double-blind, placebo-controlled study [17] .

According to a phase Ib study, analysis of the tissue from surgically removed tumours showed that significant concentrations of the active metabolite, WX UK1, could be achieved in tumour tissue [16] .

Adverse Events

Phase II

combination therapy with upamostat and capecitabine was safe and well tolerated as a first-line treatment in a phase II trial in 132 patients with HER2-receptor negative metastatic breast cancer [9] [10] .

Daily oral treatment with upamostat at 200 or 400 mg was safe and well tolerated in a phase II trial in 95 patients with locally advanced, inoperable and non-metastatic pancreatic cancer [20] [21] .

Phase I

upamostat appeared to be well tolerated at all multiple escalating dose levels tested in healthy male volunteers, in a phase I, double-blind, placebo-controlled trial [17] .

Pharmacodynamics

Summary

In a rat breast adenocarcinoma model, upamostat (0.01-10.0 mg/kg/day) given by oral gavage for 6 weeks, reduced median primary tumour size by 36-66%, with the least effect observed after the lowest dose. Upamostat also significantly reduced (33-42%) the median weight of the axillary lymph nodes at doses of ≥ 0.1 mg/kg, with the greatest reduction after the highest dose. Similarly, the agent reduced the median number of lung foci across all dose levels with significant reductions observed after doses of ≥ 0.1 mg/kg (33-44%). The effect of upamostat at doses of ≥ 0.01 mg/kg did not appear to be dose-related [37] .

Therapeutic Trials

Breast cancer: first-line therapy with upamostat in combination with capecitabine increased progression free survival (PFS) and objective tumour response compared with capecitabine alone in a phase II trial in 132 patients with HER2-receptor negative metastatic breaks cancer. In the total intent to treat (ITT) study population, the capecitabine group had a median progression free survival of 7.5 months compared with 8.3 months in the combination therapy group. The objective tumour response rates were 9% and 17%, respectively, in the capecitabine and capecitabine plus upamostat groups. Subgroup analysis showed that there was an increase in PFS in caucasian patients from 7.5 months to 9.1 months in the combination therapy group. Additionally, patients who received adjuvant chemotherapy following the primary diagnosis of breast cancer, PFS rates were 4.3 months in the capecitabine group and 8.3 months in the combination therapy group [9] [10] .

Pancreatic cancer: daily oral treatment with upamostat at 200 or 400 mg in combination with gemcitabine, was associated with improvement in tumour response and an increase in overall survival compared with gemcitabine monotherapy, in a phase II trial in patients with pancreatic cancer. In this open-label trial, patients with locally advanced, inoperable, non-metastatic pancreatic cancer were randomised to receive either gemcitabine monotherapy, or gemcitabine plus upamostat (200 or 400 mg, once-daily), until disease progression [21] . According to the final results for 95 patients, gemcitabine alone demonstrated a tumour response rate of 15.4%, whereas co-administration of upamostat 200mg or 400mg resulted in response rated of 21.4% and 35.5%. Progression free survival (PFS) improved by 66%. In the group receiving gemcitabine alone, 16.2% of patients did not progress at 12 months, as determined by computer tomography. Co-administration of upamostat 200mg and 400mg improved PFS to 22.5% and 26.9% of patients, respectively. One year survival increased by 49%; with gemcitabine alone it was 33.9%. This increased to 40.7% and 50.6% with upamostat 200mg and 400mg, respectively. Median survival improved by 26% from 9.9 months with gemcitabine alone, to 12.5 months when combined with upamostat 400mg [20] .

Future Events

Expected Date Event Type Description Updated
30 Jun 2018 Trial Update RedHill plans a phase I/II trial for Pancreatic cancer in Germany in the first half of 2018 [36] 28 Aug 2017

Development History

Event Date Update Type Comment
20 Apr 2020 Licensing Status RedHill Biopharma and National Institute of Allergy and Infectious Diseases agree to co-develop upamostat for COVID-2019 infections [2] Updated 22 Apr 2020
13 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in Israel (PO) [34] Updated 18 Mar 2020
13 Mar 2020 Trial Update RedHill Biopharma plans a phase II trial for Cholangiocarcinoma (Inoperable/Unresectable, Late-stage disease, Combination therapy, Second-line therapy or greater) in USA [34] Updated 18 Mar 2020
22 Jan 2019 Trial Update Link Health plans a phase II trial for Cancer in China [5] Updated 23 Jan 2019
31 Dec 2018 Regulatory Status The Chinese National Medical Product Administration approves IND application for upamostat in Cancer [27] [5] Updated 23 Jan 2019
01 Aug 2018 Phase Change - Clinical Clinical trials in Gastrointestinal disorders (PO) [33] (RedHill Biopharma pipeline, August 2018) Updated 08 Aug 2018
20 Oct 2017 Regulatory Status Upamostat receives Orphan Drug status for Pancreatic cancer (Adjuvant therapy) in USA [18] Updated 25 Oct 2017
19 Oct 2017 Company Involvement WILEX AG is now called Heidelberg Pharma AG Updated 20 Nov 2017
18 Sep 2017 Phase Change - Clinical Clinical trials in Cancer (Combination therapy) in USA (PO) [35] Updated 28 Sep 2017
18 Sep 2017 Patent Information RedHill Biopharma receives patent allowance for Yeliva® and Mesupron in USA [35] Updated 20 Sep 2017
10 Aug 2017 Trial Update RedHill plans a phase I/II trial for Pancreatic cancer in Germany in the first half of 2018 [36] Updated 28 Aug 2017
05 Jan 2017 Licensing Status RedHill Biopharma and Aarhus University enter into a research collaboration for evaluation of molecular targets of upamostat [8] Updated 09 Jan 2017
13 Jan 2016 Regulatory Status Link Health files an IND application with the China Food and Drug Administration in China for Solid tumours [25] Updated 14 Jan 2016
13 Jan 2016 Trial Update Link Health plans a phase I trial for Solid tumours in China [25] Updated 14 Jan 2016
13 Jan 2016 Trial Update Link Health plans two phase II trials in Cancer [25] Updated 14 Jan 2016
01 Jan 2016 Phase Change - Preclinical Preclinical trials in Solid tumours in China (PO) [28] Updated 28 Mar 2019
30 Jun 2015 Active Status Review Upamostat is still in phase II development for Breast cancer (Combination therapy, First-line therapy, Metastatic disease) in USA, Belgium, Brazil, Germany and Israel and for Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Germany, Hungary, Italy, Russia, Spain and Ukraine Updated 24 Aug 2015
25 Feb 2015 Patent Information RedHill Biopharma has patent protection for upamostat worldwide Updated 27 Nov 2015
30 Jun 2014 Licensing Status Upamostat licensed to RedHill Biopharma worldwide excluding China, Hong Kong, Taiwan and Macau [6] Updated 01 Jul 2014
28 Mar 2014 Licensing Status Upamostat licensed to Link Health Group in China, Hong Kong, Taiwan & Macao [3] Updated 03 Apr 2014
06 Mar 2013 Phase Change - Discontinued(I) Discontinued - Phase-I for Head and neck cancer in Germany (PO) Updated 06 Mar 2013
27 Feb 2013 Licensing Status Upamostat is available for licensing as of 27 Feb 2013. www.wilex.com Updated 05 Mar 2013
15 Jun 2012 Scientific Update Efficacy, adverse events and pharmacokinetic data from a phase II trial in patients with HER2-receptor negative breast cancer released by Wilex [9] Updated 17 Jun 2012
30 Apr 2012 Trial Update Wilex completes a phase II trial in Breast cancer in USA, Brazil, Israel, Belgium & Germany (NCT00615940) Updated 18 Apr 2013
05 May 2011 Trial Update Wilex completes enrolment in its phase II trial for Breast cancer (Combination therapy, First-line therapy, Metastatic disease) in the US, Belgium, Brazil, Germany and Israel (NCT00615940) Updated 09 May 2011
07 Jun 2010 Scientific Update Final efficacy & adverse events data from the phase II WILEX-WX-60-004 trial in Pancreatic cancer presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO-2010) [20] Updated 10 Jun 2010
03 May 2010 Scientific Update Interim efficacy and adverse event data from a phase II trial in Pancreatic cancer released by Wilex (ADNM) Updated 06 May 2010
03 May 2010 Trial Update Wilex completes a phase II trial in Pancreatic cancer in the EU, Russia and the Ukraine Updated 06 May 2010
31 Jul 2008 Phase Change - II Phase-II clinical trials in Breast cancer in Belgium (PO) Updated 16 Feb 2009
31 Jul 2008 Phase Change - II Phase-II clinical trials in Breast cancer in Brazil (PO) Updated 16 Feb 2009
31 Jul 2008 Phase Change - II Phase-II clinical trials in Breast cancer in Germany (PO) Updated 16 Feb 2009
31 Jul 2008 Phase Change - II Phase-II clinical trials in Breast cancer in Israel (PO) Updated 16 Feb 2009
31 Jul 2008 Phase Change - II Phase-II clinical trials in Breast cancer in USA (PO) Updated 16 Feb 2009
24 Jul 2008 Trial Update Wilex completes enrolment in its phase II trial for Pancreatic cancer in Europe Updated 25 Jul 2008
28 Jan 2008 Regulatory Status US FDA approves IND application for WX 671 in metastatic Breast cancer Updated 31 Jan 2008
13 Oct 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Spain (PO) Updated 06 Mar 2013
13 Oct 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Italy (PO) Updated 06 Mar 2013
24 Sep 2007 Trial Update Wilex AG completes a phase Ib trial in head and neck cancer in Germany Updated 26 Sep 2007
07 Sep 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Hungary (PO) Updated 06 Mar 2013
30 Jul 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Germany (PO) Updated 06 Mar 2013
26 Jun 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Ukraine (PO) Updated 16 Feb 2009
26 Jun 2007 Phase Change - II Phase-II clinical trials in Pancreatic cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Russia (PO) Updated 16 Feb 2009
16 Aug 2006 Scientific Update Clinical data from a media release have been added to the adverse events and pharmacokinetics sections [17] Updated 17 Aug 2006
07 Aug 2006 Phase Change - I Phase-I clinical trials in Head and neck cancer in Germany (PO) Updated 16 Aug 2006
07 Aug 2006 Trial Update Wilex has completed the phase I, multiple escalating dosing trial for Solid tumours in Germany Updated 16 Aug 2006
30 Dec 2005 Trial Update Wilex has initiated a phase I, multiple escalating dosing trial for Solid tumours in Germany Updated 16 Aug 2006
27 Jul 2005 Trial Update Wilex has completed a phase I, single escalating dosing trial for Solid tumours in Germany Updated 28 Jul 2005
04 May 2005 Scientific Update Data presented at the 96th Annual Meeting of the American Association for Cancer Research (AACR-2005) have been added to the Cancer pharmacodynamics section [37] Updated 04 May 2005
20 Sep 2004 Phase Change - I Phase-I clinical trials in Solid tumours in Germany (PO) Updated 01 Oct 2004

References

  1. WILEX AG successfully completes change of name to Heidelberg Pharma AG.

    Media Release
  2. RedHill Biopharma Announces Agreement with NIAID to Evaluate RHB-107 Against COVID-19.

    Media Release
  3. WILEX enters into licensing and development partnership for MESUPRON(Rm) in China with Link Health Group.

    Media Release
  4. Interim management statement on the first quarter of 2016.

    Media Release
  5. Heidelberg Pharma Receives Milestone Payment From Partner Link Health.

    Media Release
  6. WILEX and RedHill Biopharma enter into an exclusive license agreement for MESUPRON(Rm).

    Media Release
  7. Heidelberg Pharma AG: Partner RedHill Announces Orphan Drug Designation for MESUPRON.

    Media Release
  8. RedHill Biopharma Announces New Research Collaboration with Aarhus University for Oncology Drug MESUPRON.

    Media Release
  9. MESUPRON(Rm) met its primary objective of demonstrating efficacy in the proof of concept phase II breast cancer trial.

    Media Release
  10. A Phase 2, Two-Arm, Double-Blind, Multi-Center, Randomized Study of the Combination of Oral WX-671 [Wilex] Plus Capecitabine [Xeloda; Hoffman La Roche AG] vs. Capecitabine Monotherapy in First-Line Her2-Negative Metastatic Breast Cancer.

    ctiprofile
  11. WILEX reports on a successful financial year 2011.

    Media Release
  12. Patient recruitment in Phase II breast cancer trial with MESUPRON(Rm) successfully completed.

    Media Release
  13. WILEX receives US FDA approval (IND) for clinical Phase II trial with its uPA inhibitor WX-671 in metastatic breast cancer.

    Media Release
  14. WILEX publishes half-yearly financial report 2013.

    Media Release
  15. Phase Ib trial to evaluate the tolerability and pharmacokinetics of neoadjuvant WX 671 in patients with head and neck cancer.

    ctiprofile
  16. Phase Ib trial with WX-671 in patients with head & neck cancer successfully completed.

    Media Release
  17. WILEX completes Phase I program with anti-cancer drug WX-671 in healthy volunteers and conducts clinical Phase Ib study in cancer patients now.

    Media Release
  18. RedHill Biopharma Receives FDA Orphan Drug Designation for MESUPRON for Pancreatic Cancer.

    Media Release
  19. A randomized, open label, phase II proof of concept study of WX-671 in combination with gemcitabine vs. gemcitabine alone in patients with locally advanced, non resectable pancreatic cancer in order to evaluate the anti-tumor activity of the combination therapy.

    ctiprofile
  20. WILEX presents at ASCO positive final phase II data of MESUPRON(Rm) in pancreatic cancer.

    Media Release
  21. Final Phase II data of MESUPRON (Rm) confirm impressive increase in overall survival of patients with pancreatic cancer.

    Media Release
  22. Patient recruitment in Phase II trial with MESUPRON(R) (WX-671) in pancreatic cancer patients successfully completed.

    Media Release
  23. Patient recruitment started in clinical Phase II trial with WX-671 in pancreatic cancer.

    Media Release
  24. WILEX receives approval for clinical Phase II trial with oral WX-671 in pancreatic cancer.

    Media Release
  25. WILEX's partner Link Health submits IND application for clinical Phase I with the uPA inhibitor MESUPRON(R) in China.

    Media Release
  26. A phase I dose escalation study of Upamostat in Chinese patients with solid tumour

    ctiprofile
  27. Heidelberg Pharma AG: Interim Management Statement on the First Nine Months of 2019.

    Media Release
  28. Heidelberg Pharma announces financial figures for fiscal year 2018 and provides business update.

    Media Release
  29. Wilex successfully completes first clinical Phase I study with new anti-cancer drug WX-671.

    Media Release
  30. Wilex starts clinical trial with new anti-cancer compound WX-671.

    Media Release
  31. Interim Management Statement on the First Nine.

    Media Release
  32. RedHill Biopharma Provides Update on Development Pipeline and Expected Timing for RHB-105 Phase III Top-Line Results.

    Media Release
  33. RedHill Biopharma Elaborates on Its Announced Positive Top-Line Results from Phase III Study of RHB-104 in Crohns Disease.

    Media Release
  34. RedHill Biopharma Provides Update on Opaganib (Yeliva(R)).

    Media Release
  35. RedHill Biopharma Receives Notice of Allowance for a New U.S. Patent Covering its Combination Therapy for Hard-to-Treat Cancers.

    Media Release
  36. RedHill Biopharma Provides 2017 Semi-Annual Business Update - 10 Aug 2017 .

    Media Release
  37. Setyono-Han B, Foekens J, Schmalix WA. Anti-cancer and anti-metastatic activity of the oral uPA-inhibitor WX-671 in the rat BN472 breast cancer model. 96th-AACR 2005;461374.

  38. RedHill Biopharma Reports 2016 Fourth Quarter and Full-Year Financial Results.

    Media Release
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