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pharmafile | September 17, 2007 | News story | Research and Development, Sales and Marketing |
Cell Therapeutics launches Phase III study for pixantrone
Cell Therapeutics has launched its phase III clinical trial, known as PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma who have relapsed following first-line therapy.
The randomised trial enrols 300 patients and expects to complete over a 12 to 16-month period. Depending on the rate of progression, an interim analysis is targeted for 2009.
The trial will examine progression-free survival, which is the rate at which a patient's lymphoma recurs or progresses, following treatment with pixantrone, fludarabine and rituximab (FP-R), compared to treatment with fludarabine and rituximab.
James Bianco, president and CEO, said: "We have previously shown in a randomised controlled trial that the addition of pixantrone to rituximab significantly increased median time to progression over rituximab alone in relapsed indolent non-Hodgkin's lymphoma patients. That data, coupled with the marked increase in progression-free survival when pixantrone was added to a fludarabine-based regimen, provides a strong rationale for proceeding with this trial which could expand the application into the larger indolent non-Hodgkin's lymphoma market."
Related links:
Cell Therapeutics Inc: LSA company profile
Non-Hodgkin Lymphoma Drug Pipeline Report
Stakeholder Opinions: Non-Hodgkin's Lymphoma – Immunotherapy Stimulates the Market
Hollis-Eden reports promising results for multiple sclerosis treatment
Hollis-Eden Pharmaceuticals has announced new data showing that its pre-clinical drug candidate provides benefit in an animal model of multiple sclerosis.
The company is planning to present the results evaluating HE3286 at the 2nd International Congress on Immune-Mediated Diseases being held in Moscow, Russia. The company is also presenting preclinical data demonstrating that HE3286, along with other novel compounds under investigation – HE3413 and HE3177, appear to act by limiting the activation of the pro-inflammatory transcription factor NF-kappaB.
In the data presented, HE3286 showed marked benefit in a SJL/J female mouse model of experimental autoimmune encephalitis, a model widely used in industry and academia to test agents as potential treatments for multiple sclerosis.
In the study, mice were treated orally at disease onset with either HE3286 or placebo for approximately 20 days. HE3286-treated mice, at doses as low as 4mg/kg, had markedly reduced disease scores in comparison to placebo-treated animals. Benefit was maintained for over two weeks, even after treatment was discontinued.
Dr Halina Offner, professor of Neurology at Oregon Health Science Center, said: "We continue to be excited about researching these new steroid hormones because of their apparent ability to regulate critical inflammatory targets such as NF-kappaB and T-regulatory cells."
Richard Hollis, chairman and CEO, said: "We are pleased that HE3286 continues to perform well in preclinical models of diseases of inflammation. We intend to file an IND to support a Phase I/II clinical trial with HE3286 in diseases of inflammation this month. This IND would enable us to potentially test HE3286 not only in rheumatoid arthritis but in additional diseases of inflammation."
Related links:
Hollis-Eden Pharmaceuticals Inc: LSA company profile
Central Nervous System – Multiple Sclerosis Drug Pipeline Report
Pipeline Insight: Multiple Sclerosis – The oral revolution
Xoma initiates phase I diabetes trial
Xoma has initiated a second phase I study of its monoclonal antibody targeting interleukin-1 beta, in patients with type 2 diabetes.
The Europe-based study, designed to assess the safety and pharmacokinetics of Xoma 052, will enrol up to 36 subjects with type 2 diabetes and includes disease-specific outcome measurements. The trial will also strengthen Xoma's involvement with the European researchers and institutions specialized in the investigation of the IL-1 disease pathway in diabetes.
Marc Donath, professor at the University Hospital of Zurich, is the study's principal investigator.
The US-based trial is currently ongoing. The company expects to use the safety data from the two phase I studies to guide the development of Xoma 052 in type 2 diabetes and to evaluate its relevance for other inflammatory indications, which may include rheumatoid arthritis, systemic juvenile idiopathic arthritis and osteoarthritis.
Alan Solinger, vice president of clinical immunology, said: "We are optimistic about the therapeutic potential of Xoma 052 for use in the treatment of multiple inflammatory diseases. The importance of the IL-1 pathway for rheumatoid arthritis is already well documented in humans."
Steven Engle, CEO and president, added: "We are excited by the potential of Xoma 052 to address a number of chronic diseases with major unmet medical needs, and look forward to evaluating options for its broader clinical development. This novel, high-affinity antibody addresses a disease pathway where the pathogenic impact of the pathway and beneficial effect of intervention have been demonstrated in humans."
Related links:
Metabolic Endocrinology – Type I Diabetes Drug Pipeline Report
Metabolic Endocrinology – Type II Diabetes Drug Pipeline Report
The Diabetes Market Outlook to 2011
Non-insulin Antidiabetics – Type 2 diabetes unlikely to develop into a switch market
Erbitux increases overall survival in phase III lung cancer study
ImClone Systems and Bristol-Myers Squibb have reported that a phase III study of Erbitux in combination with platinum-based chemotherapy met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced non-small cell lung cancer.
The randomised multinational study was conducted by Merck KGaA, and enrolled patients with stage IIIB or stage IV non-small cell lung cancer who had not previously received chemotherapy.
Eric Rowinsky, senior vice president of ImClone Systems, said: "Based on the first-line treatment for patients results, Erbitux is the only member of the class of epidermal growth factor inhibitors to demonstrate survival in the first-line treatment of patients with advanced non-small cell lung cancer. Previous pivotal trials involving other agents targeting epidermal growth factor inhibitor have failed to demonstrate a survival advantage for these patients."
Martin Birkhofer, vice president, added: "Studies have shown that Erbitux improves overall survival for patients with certain head and neck cancers, and now, with the first-line treatment for patients data, for patients with advanced non-small cell lung cancer."
Erbitux (cetuximab) was discovered by ImClone Systems and is distributed in North America by ImClone and Bristol-Myers Squibb, while in the rest of the world distribution is by Merck KGaA.
Related links:
ImClone Systems: LSA company profile
Bristol-Myers Squibb Company: LSA company profile
Non-Small Cell Lung Cancer – Angiogenesis and signal transduction inhibitors to expand market
Stakeholder Insight: Non-Small Cell Lung Cancer
Ariad reaches agreement with FDA for phase III cancer drug trial
Ariad Pharmaceuticals has reached agreement on a special protocol assessment with the FDA for its global phase III trial of oral deforolimus in patients with metastatic sarcomas.
Based on the assessment, progression-free survival (PFS) will be the primary endpoint of the phase III trial and overall survival will be a secondary endpoint. The company expects to begin patient enrolment in the trial later in September.
The special protocol assessment (SPA) is a written agreement between the trial's sponsor and the FDA regarding the design, endpoints, and planned conduct and analysis of a trial to be used in support of regulatory approval.
The European Medicines Agency (EMEA) has provided protocol advice consistent with that of the FDA regarding the phase III trial design as part of its protocol assistance programme. Ariad and Merck & Co. have a global collaboration to jointly develop and commercialize deforolimus for use in cancer.
Ariad and Merck plan to conduct a phase III trial of oral deforolimus in patients with metastatic soft tissue and bone sarcomas following a favourable response to chemotherapy – a period when continued treatment with traditional chemotherapeutic agents has not been established to provide additional clinical benefit.
This double-blind trial is designed to evaluate approximately 650 patients who will be randomised (1:1) to oral deforolimus or placebo at approximately 125 sites. Complete patient enrolment and the second interim analysis are expected to take place within approximately two years of the first patient being enrolled.
Pierre Dodion, senior vice president of oncology at Araid, said: "FDA agreement on our overall phase III trial design, patient population and endpoints, as well as our newly established partnership with Merck represent important achievements for the global development of deforolimus."
Related links:
Ariad Pharmaceuticals Inc: LSA company profile
Pipeline Insight: Therapeutic Cancer Vaccines – A turbulent path from bench to bedside
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
Innovative and Targeted Cancer Therapies: Key technologies, new applications and leading players
