We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Bristol Myers Squibb Co | NYSE:BMY | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.19 | 0.43% | 44.83 | 3,742 | 12:33:32 |
Bristol-Myers Squibb Company (NYSE:BMY) and The University of Texas MD Anderson Cancer Center today announced a novel clinical research collaboration to evaluate multiple immunotherapies, including Opdivo (nivolumab), Yervoy (ipilimumab) and three early-stage clinical immuno-oncology assets from Bristol-Myers Squibb, as potential treatment options for acute and chronic leukemia as well as other hematologic malignancies.
The agreement represents an innovative approach to research by focusing numerous clinical trials using multiple agents, in mono and combination regimens, on a specific disease target, in this case select hematologic malignancies. Through this approach, Bristol-Myers Squibb and MD Anderson aim to benefit patients by expediting the delivery of new therapies. The collaboration will launch up to 10 phase 1 and 2 clinical trials, conducted by MD Anderson, focused on evaluating investigational immune-based approaches for acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS) and myelofibrosis (MF). Additional studies will be determined by the collaboration at a later date.
Opdivo (nivolumab) is an investigational PD-1 immune checkpoint inhibitor currently approved in Japan for the treatment of patients with unresectable melanoma, and Yervoy (ipilimumab) is a CTLA-4 immune checkpoint inhibitor approved in the U.S. and more than 40 countries for patients with unresectable or metastatic melanoma. Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.
“Collaborations between industry and academia can offer a faster and broader spectrum of clinical trials to benefit patients,” said Hagop Kantarjian, M.D., chair of leukemia at MD Anderson. “We hope innovative collaborations such as this can help lead to a higher likelihood for success across the board and will speed up the clinical development of new compounds for delivery to the patients who need them.”
“Immunotherapy is an extremely promising area of research and a key area of focus for MD Anderson’s Moonshots Program,” said MD Anderson President Ron DePinho, M.D. “Partnerships between academia and industry have the potential to significantly advance the application of new discoveries to cancer treatment.”
“Bristol-Myers Squibb is committed to advancing the field of immuno-oncology and complementing our broad research and discovery programs through innovative collaborations with partners who share our commitment to patients,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “Cooperation between industry and academia offers a tremendous opportunity to strengthen our scientific and clinical understanding of the role of the immune system in treating cancer.”
Immuno-oncology is an innovative approach to cancer research and treatment that is designed to harness the body’s own immune system to fight cancer. Hematologic malignancies represent significant areas of high unmet need marked by poor outcomes among the elderly, high-risk patients and for those with multiple relapses. Existing clinical research, including studies by MD Anderson, support further research into the potential of immunotherapies as treatment options for leukemia and other hematologic malignancies.
About Opdivo (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end. The FDA granted its first Breakthrough Therapy Designation for Opdivo in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. On September 26, Bristol-Myers Squibb announced that the FDA accepted for priority review the Biologics License Application (BLA) for previously treated advanced melanoma, and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The EMA also validated for review the MAA for nivolumab in NSCLC.
About Yervoy (ipilimumab)
Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries, including Taiwan. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. This includes Phase 3 trials in prostate and lung cancers.
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is leading advances in the innovative field of immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.
Yervoy (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION
Yervoy (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
Yervoy can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.
Permanently discontinue Yervoy and initiate systemic high-dose corticosteroids for sever immune-mediated reactions.
Recommended Dose Modifications
Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.
Permanently discontinue Yervoy for any of the following:
Immune-mediated Enterocolitis:
Immune-mediated Hepatitis:
Immune-mediated Dermatitis:
Immune-mediated Neuropathies:
Immune-mediated Endocrinopathies:
Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:
Pregnancy & Nursing:
Common Adverse Reactions:
Please see Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, available at www.bms.com www.bms.com
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. MD Anderson is one of only 41 comprehensive cancer centers designated by the National Cancer Institute (NCI). For the past 25 years, MD Anderson has ranked as one of the nation's top two cancer centers in U.S. News & World Report's annual "Best Hospitals" survey. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
Get MD Anderson News Via RSS
Follow MD Anderson News on Twitter
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the immunotherapies discussed in this release will be successfully developed or approved for any of the indications described in this release, such as acute and chronic leukemia and other hematologic malignancies. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bristol-Myers SquibbMedia:Ken Dominski, 609-252-5251ken.dominski@bms.comorLaura Hortas, 609-252-4587laura.hortas@bms.comorMD Anderson Cancer CenterMedia:Ron Gilmore, 713-745-1898rlgilmore1@mdanderson.orgorBristol-Myers SquibbInvestors:Ranya Dajani, 609-252-5330ranya.dajani@bms.comorRyan Asay, 609-252-5020ryan.asay@bms.com
1 Year Bristol Myers Squibb Chart |
1 Month Bristol Myers Squibb Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions