Teresa F. Winslow has been named senior vice president, global business development and James Miskel has been appointed vice president, strategy and corporate development, MDS Pharma Services. Ms. Winslow will direct global business development efforts and Mr. Miskel will focus on strategic partnerships.
   
"I'm delighted to add these two experienced leaders to our senior management team," said MDS Pharma Services president David Spaight. "Their skills and knowledge will allow us to seize emerging opportunities to accelerate the growth of our business."
   
Ms. Winslow is an experienced executive leader of business development in the healthcare industry. She previously served as president, Dendrite Americas and senior vice president, Dendrite International, a supplier of sales force and marketing effectiveness solutions for the pharmaceutical industry. Ms. Winslow was responsible for operations, sales and marketing functions and led double-digit growth of the company's largest division.  
   
Mr. Miskel joins the company from Wyeth Pharmaceuticals, where he was assistant vice president for business planning and strategy. He spent much of his career with McKinsey & Co. leading growth strategy, operational improvement, and acquisition work in the Americas and Europe for pharmaceutical and medical device companies.  

Pfizer has discontinued a Phase III clinical trial of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma, after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.

The company has communicated with worldwide regulatory authorities and investigators regarding the discontinuation of the trial. Investigators will work with their patients to determine if they are benefiting from treatment and therefore should continue treatment with tremelimumab.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high risk area of research with significant unmet medical need. We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer," said Charles Baum, M.D., Ph.D., vice president and Oncology Therapeutic Area head at Pfizer Global Research and Development. "We will continue to assess the study data to understand the clinical benefit seen in some patients who received tremelimumab."

The full data set from the study is being analyzed, and more details are expected to be available at the American Society for Clinical Oncology Annual Meeting in June 2008.

"We have a robust pipeline within Pfizer Oncology and we remain committed to the discovery and development of novel cancer treatments which hold promise for patients with cancer," said Dr. Baum. "We are extremely grateful for the strong support we have received for this clinical trial from the physicians, study staff, and most importantly from the patients."

Pfizer is developing several classes of agents in its Immuno-Oncology pipeline including CD40 agonists, toll-like receptor (TLR) agonists and vaccines.

Abraxis BioScience, Inc. has initiated enrollment in its Phase II clinical trial to evaluate the efficacy and safety of Coroxane for the prevention and reduction of restenosis following revascularization of the superficial femoral artery (SFA).

Coroxane (nanometer-sized paclitaxel and Abraxane) is a novel, solvent-free, albumin-bound form of paclitaxel used for cardiovascular applications. Abraxane is the first and only approved protein-bound, nanometer-sized, solvent-free taxane and is the first commercial product to validate Abraxis’ proprietary nab technology platform. Abraxane is marketed for the treatment of breast cancer.

Earlier preclinical and clinical studies investigated the potential for Coroxane as an alternative to drug eluting stents in coronary arteries. Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis,  noted that the company currently intends to seek a strategic partner for the development and marketing of Coroxane.

Tthe Phase II trial, led by principal investigator John Rundback, M.D., director of the Interventional Institute at Holy Name Hospital in Teaneck, N.J. and Associate Professor of Clinical Radiology at Columbia University College of Physicians and Surgeons, is a randomized, open-label, prospective, multicenter study that will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis in the SFA.

“The present study is an important step forward in providing a treatment alternative to patients with moderate to long segment SFA disease using Coroxane. The novel mode of delivery allows platform independent treatment and can be used regardless of the initial revascularization method," said Dr. Rundback. "Since drug eluting stents have not yet clearly shown long-term benefit, a different strategy for delivering this very bioactive agent to the site of balloon injury has tremendous potential to expand the therapeutic options and improve outcomes for these patients."

Approximately 150 patients will be monitored for restenosis of the target vessel at nine months as evaluated by angiography and duplex ultrasound.

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