Tag Archives: CSF

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Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for t

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By Business Wirevia The Motley Fool

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Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for the Treatment of Chemotherapy-Induced Neutropenia

  • In U.S.-based Phase 1 trial, SPI-2012 demonstrated increase of neutrophil count similar to Neulasta ® (pegfilgrastim) at one-third the dose.
  • Pending clinical progress and regulatory approval, SPI-2012 will enter a worldwide market estimated to be over $5 billion.
  • Spectrum has global rights for SPI-2012 except for Korea, China, and Japan.

HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has initiated a Phase 2 clinical program for SPI-2012 (also referred to as “LAPS-GCSF”), a drug candidate for the treatment of chemotherapy-induced neutropenia that utilizes partner Hanmi Pharmaceutical Company‘s proprietary LAPSCOVERY™ Technology. This technology, as shown in preclinical models, permits greater marrow penetration and retention of G-CSF when compared to naked CSF and avoids elimination through kidney. In a previous Phase 1 trial in healthy volunteers SPI-2012 showed increase in neutrophil count similar to Neulasta® (pegfilgrastim) at one-third the dose.

“We are excited to begin mid-stage clinical studies for a drug candidate that can become a key component of Spectrum’s long-term growth,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Chemotherapy-induced neutropenia constitutes a large global market estimated to be over $5 billion, and there is preliminary evidence showing SPI-2012 may have advantages over the comparator regarding the intensity and duration of neutrophil recovery. We look forward to the continued study of this product candidate, which we believe has the potential to address continued unmet medical needs by studying the opportunity to minimize the risks from chemotherapy induced neutropenia.”

Spectrum’s phase 2 trial is a multicenter, open label, dose-ranging study, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed and standard dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012. The primary objective and endpoint of this study is to assess the effect of test doses of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in patients with breast …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Accretive Health Achieves Industry-Leading HITRUST Certification for Data Security and Protection of

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Accretive Health Achieves Industry-Leading HITRUST Certification for Data Security and Protection of Private Patient Health Information

CHICAGO–(BUSINESS WIRE)– Accretive Health, Inc. (NYS: AH) announced today that it has achieved from the Health Information Trust Alliance (HITRUST) Common Security Framework (CSF) Certified status. This status assures that Accretive Health is meeting the health care industry’s highest standards in managing risk and protecting health information. Achieving HITRUST CSF Certified status from HITRUST is vital as electronic health record-sharing expands.

“HITRUST has been working with the industry to ensure the appropriate information protection requirements are met when sensitive health information is accessed, used and stored,” said Kenneth Vander Wal, Chief Compliance Officer of HITRUST. “We are pleased that Accretive Health has taken the steps necessary to achieve HITRUST CSF Certified status, and we expect its customers to have confidence in this designation.”

The HITRUST CSF is the most widely-adopted security framework in the U.S. healthcare industry. Accretive Health obtained CSF Certified status by meeting all of the applicable CSF requirements, which include rigorous encryption and inventory management policies and practices as well as ongoing security monitoring and comprehensive review performed by a third party HITRUST CSF Assessor organization.

Accretive Health Founder and CEO Mary Tolan said, “To meet the triple aim of improving care, lowering costs, and enhancing the patient experience we have to enable health care professionals to make the best medical judgments based on the best information, while also keeping patient privacy paramount. This HITRUST designation indicates the care and diligence our organization takes to achieve health information privacy objectives in our day-to-day work.”

About Accretive Health

At Accretive Health, our mission is to help our healthcare clients strengthen their financial stability and deliver better care at a more affordable cost to the communities they serve (increasing healthcare access to all). For more information, visit www.accretivehealth.com.

About HITRUST

The Health Information Trust Alliance (HITRUST) was born out of the belief that information security should be a core pillar of, rather than an obstacle to, the broad adoption of health information systems and exchanges. HITRUST, in collaboration with healthcare, business, technology and information security leaders, has established the Common Security Framework (CSF), a certifiable framework that can be used by any and all organizations that create, access, store, or exchange personal health …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigati

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Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer’s Disease

Collaboration to Support Patient Selection for the Clinical Development of MK-8931, Merck’s Lead Investigational Medicine for Alzheimer’s Disease

WHITEHOUSE STATION, N.J. & AUSTIN, Texas–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, and Luminex Corporation (NAS: LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck’s lead investigational candidate for Alzheimer’s disease (AD). Financial terms were not disclosed.

“Evaluation of biomarkers that may provide an indicator of disease onset and enable earlier diagnosis is an important goal toward facilitating early intervention and potentially improving the treatment of Alzheimer’s disease,” said Darryle D. Schoepp, Ph.D., senior vice president, head of Neuroscience and Ophthalmology at Merck Research Laboratories. “We look forward to working with Luminex to advance our ongoing clinical development program for MK-8931.”

Luminex will be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic device, which will employ Luminex’s xMAP® Technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI). The candidate device will be evaluated as a means to identify subjects with MCI who have a higher risk of developing AD to support patient selection for Merck’s therapeutic BACE inhibitor clinical program.

“This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer’s disease,” added Patrick J. Balthrop, president and CEO of Luminex. “We are pleased to leverage our technologies and development capabilities and look forward to expanding our activity into the companion diagnostic segment of personalized medicine.”

The accumulation of beta amyloid in the brain is a key pathological characteristic related to AD. Recent clinical evidence supports the hypothesis that the measurement of the investigational biomarkers Aβ42 and t-tau in CSF may be useful in identifying patients at greater risk of developing AD. Currently, AD is diagnosed by clinical examination (i.e., medical history; physical, neurological, psychiatric and neuropsychological exams; and Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan). An AD diagnosis can only be …read more
Source: FULL ARTICLE at DailyFinance