ImmunoGen reports net loss of $21.9 million in Q4 2013
ImmunoGen, Inc., a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload antibody-drug conjugate technology, today reported financial results for the three-month period and fiscal year ended June 30, 2013. ImmunoGen also provided guidance for its 2014 fiscal year and an update on the Company.
More... |
Re: ImmunoGen reports net loss of $21.9 million in Q4 2013
Picking out the really good things from this article since no one is going to get rich off of IMGN stock anytime soon . . .
Roche is assessing Kadcyla in a number of additional indications: including for first-line treatment of HER2-positive metastatic BC (MARIANNE trial), for uses in early stage HER2-positive BC (including the KATHERINE trial), and for the treatment of advanced HER2-positive stomach cancer (GATSBY trial). The progression-free survival (PFS) endpoint of TH3RESA has been met, and Roche intends to submit these data for presentation at the ESMO annual meeting Sept. 27-Oct. 1, 2013. Roche expects results from MARIANNE in late 2014 and to apply for first-line treatment of HER2-positive metastatic BC and for treatment of advanced HER2-positive gastric cancer in 2015. |
Re: ImmunoGen reports net loss of $21.9 million in Q4 2013
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
This study is currently recruiting participants. Verified July 2013 by Hoffmann-La Roche Sponsor: Hoffmann-La Roche Collaborators: National Surgical Adjuvant Breast and Bowel Project (NSABP) German Breast Group Information provided by (Responsible Party): Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT01772472 First received: January 17, 2013 Last updated: July 29, 2013 Last verified: July 2013 History of Changes
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Purpose This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy Resource links provided by NLM: Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Trastuzumab Trastuzumab emtansine U.S. FDA Resources Further study details as provided by Hoffmann-La Roche: Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment: 1484 Study Start Date: April 2013 Estimated Study Completion Date: March 2023 Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: Trastuzumab emtansine Drug: trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks, 14 cycles Active Comparator: Trastuzumab Drug: trastuzumab 6 mg/kg intravenously every 3 weeks, 14 cycles http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria:
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01772472 Contacts Contact: Reference Study ID Number: BO27938 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com http://www.clinicaltrials.gov/ct2/ht...frame/plus.gif Show 276 Study Locations Sponsors and Collaborators Hoffmann-La Roche National Surgical Adjuvant Breast and Bowel Project (NSABP) German Breast Group Investigators Study Director: Clinical Trials Hoffmann-La Roche http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif More Information No publications provided Responsible Party: Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT01772472 History of Changes Other Study ID Numbers: BO27938, 2012-002018-37 Study First Received: January 17, 2013 Last Updated: July 29, 2013 Health Authority: United States: Food and Drug Administration Additional relevant MeSH terms: Breast Neoplasms Neoplasm, Residual Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Trastuzumab Maytansine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action ClinicalTrials.gov processed this record on August 01, 2013 |
All times are GMT -7. The time now is 03:02 AM. |
Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021