Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.

开始日期2018-04-01

申办/合作机构

St. Joseph's University

CTRI/2014/09/004959 / Recruiting临床3期

A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line.

开始日期2014-09-19

申办/合作机构

mAbxience SA

NCT02268045 / Completed临床3期

A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line

This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).
Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.

开始日期2013-05-01

申办/合作机构

mAbxience Research SL

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2024-09-01·Oncology and Therapy

Long-Term Safety and Effectiveness of Rituximab Biosimilar RTXM83: A Retrospective Extension Study in Brazilian Patients with Diffuse Large B-Cell Lymphoma

Article

作者: Werutsky, Gustavo ; da Silva Araújo, Sérgio Shusterschitz ; Higashi, Marcia ; da Silva, Roberto Luiz ; Fogliatto, Laura ; Pereira, Juliana ; Pericole, Fernando Vieira ; Salvino, Marco Aurélio ; Delamain, Marcia Torresan ; de Paulo Giacon Radtke, Patrícia ; Castilho, Vivienne ; Cardoso, Ana Carolina Ferreira

INTRODUCTION:

RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption.

METHODS:

In this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01-11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment.

RESULTS:

The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group.

CONCLUSION:

This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04928573. June 16, 2021, "retrospectively registered".

2021-11-01·Journal of pharmacy & bioallied sciences

Evaluating the Effect of Ormeloxifene on Multiple Fibroadenomas and Mastalgia

Article

作者: Bhagat, Vaishali ; Patil, Pooja ; Vasuniya, Vikram ; Brahmachari, Swagata

Introduction::

Most common benign breast conditions presenting in the breast clinics include fibroadenomas and mastalgia, both these conditions cause considerable anxiety in the patients. Among other treatment modalities, the hormonal drug treatments are gaining popularity. Ormeloxifene (centchroman) is an antiestrogenic drug which is shown to have effect in reducing the pain in mastalgia patients and the size of fibroadenoma.

Objectives::

Ormeloxifene is selective antiestrogen and a nonsteroidal drug. It has a discerning antiestrogen action and hence is useful for the treatment of mastalgia and multiple small fibroadenomas. Hence, the objective of our study was to assess the effect of Ormeloxifene (centchroman) on multiple fibroadenoma and mastalgia.

Materials and Methods::

Patients with benign breast disease attending our surgery outpatient department from June 2016 to July 2017. Patients were started on Ormeloxifene 30 mg on alternate days for a period of 3 months. Patients were followed up to 6 months after the inception of the study. Parameters recorded include the Visual Analog Scale (VAS) for pain and ultrasonography for breast lump size.

Results::

Thirty patients were included in the study. We found very good response in the mastalgia; the VAS scores in these patients dropped from 10 to 3 in 90% in the 1st week of introduction of the drug, and at the end of 1 month, almost all of the patients were painless. Overall final response was noted in terms of complete dissolution and change in the size was noted in 34% partial response in 46 %, no changes in 17 % and increase in size of fibroadenoma was noted in only one case.

Conclusion::

Novex is proved to be safe drug for the treatment of mastalgia and fibroadenoma. Its results were great in mastalgia group. At the end of 6 months, the number of surgeries (if needed) decrease and there is considerable improvement in the patient satisfaction rate.

2020-01-13·Advances in urology

Prospective Multicenter Open-Label One-Arm Trial Investigating a Pumpkin Seed, Isoflavonoids, and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: A Pilot Study

Article

作者: Mjaess, Georges ; Nemr, Elie ; Chebel, Josselin Abi ; El Helou, Elie ; Semaan, Albert

Phytotherapy for lower urinary tract symptoms (LUTSs) due to benign prostate hyperplasia (BPH) is progressively demanded by patients and trusted by physicians. The aim was to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids, and cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. Male patients aged ≥40 years, who had had mild to moderate LUTS for >6 months at screening, with no previous therapy or who are still symptomatic despite current use of alpha-blockers, were recruited. Exclusion criteria were an IPSS >19 and an age >80 years. The mixed compound was administered orally, daily, for 3 months. Patients were evaluated by means of IPSS, urological quality of life (uQoL) index, and International Index of Erectile Function (IIEF-5) at 3 visits: baseline (visit 1), 30 days (visit 2), and 90 days after treatment (visit 3). Among 163 screened patients, 128 patients (61.8 ± 9.9 years) were recruited. IPSS improved from 15 (Q1 : 12–Q3 : 17) in visit 1, to 11 (Q1 : 8–Q3 : 14) in visit 2, and to 9 (Q1 : 6–Q3 : 12) in visit 3 (p<0.001). uQoL improved from 4 (3–4) in visit 1, to 3 (2–3) in visit 2, and to 2 (1–2) in visit 3 (p<0.001). The patients had an IIEF-5 score of 15 (12–18.7) in visit 1, 15 (12–18) in visit 2, and 17 (13–19) in visit 3 (p=0.99 visits 1 vs. 2, p=0.004 visits 2 vs. 3, and p=0.001 visits 1 vs. 3). Treating mild to moderate LUTS/BPH patients with Novex® might therefore relieve symptoms, improve the quality of life, and have a mild beneficial effect on erectile function.

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2023-01-20

·PipelineReview

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

HYDERABAD, India I January 20, 2023 I Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions. DRL_RI is being developed as a biosimilar of rituximab, a cluster of differentiation 20 (CD20) directed cytolytic antibody for approval in the United States, European Union and other regions for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company undertook further clinical development to meet regulatory requirements of highly regulated markets. With the successful completion of these clinical studies, Dr. Reddy’s is now preparing to file Biologics License Application (BLA) / Marketing Authorisation Application (MAA) dossiers with various regulatory authorities globally. Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said : “This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets. These results underscore our commitment to developing high quality biosimilars and reinforce the potential of DRL_RI as a safe and effective treatment option to patients across the globe.” Dr. Reddy’s is currently collaborating with its partner Fresenius Kabi to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly. About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI: *EU reference medicinal product is MabThera® **U.S. reference product is Rituxan® MabThera® and Rituxan® are registered trademarks of Roche. About Dr. Reddy’s biosimilars programme: Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and future growth. Over the last 20 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India and over 25 Emerging Markets. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We recently announced the successful completion of Phase I study and initiation of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab, for global markets. We are also ramping up manufacturing capacity to support our global expansion plans. About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. SOURCE: Dr. Reddy’s

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