|Cerulean Pharma Doses First Patients in Randomized Phase 2 Clinical Study of CRLX101 in Non-Small Cell Lung Cancer|
2011-07-12 14:14:46 -
Cerulean Pharma Inc : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. ., a leader in designing and developing tumor-targeted nanopharmaceuticals, today announced the dosing of the first patients with CRLX101 in a randomized, controlled non-small cell lung cancer (NSCLC) Phase 2 clinical trial.
“The initiation of this Phase 2 study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, Ph.D., president and chief
executive officer of Cerulean. “Cerulean is excited to develop CRLX101 as a potential new therapy for lung cancer patients who otherwise have limited treatment options.”
The primary objective of the Phase 2 study is to assess the efficacy and safety of CRLX101 in advanced NSCLC patients whose disease has progressed following one or two prior regimens of therapy. Approximately 150 patients are anticipated to be enrolled in this study at 26 clinical trial sites in Russia and Ukraine. Patients will be randomized 2:1 to receive either CRLX101 plus best supportive care or best supportive care, respectively. Patients will be evaluated for overall survival, progression-free survival, tumor response, and pharmacokinetic parameters.
“Cerulean is a leading developer of cancer-focused nanopharmaceuticals and I am thrilled to advance this tumor-targeted agent into Phase 2 development,” said Edward Garmey, M.D., chief medical officer of Cerulean. “Based on exciting preclinical and clinical data, CRLX101 has the potential to be effective in both squamous and non-squamous histology patient populations, as well as in patients with a variety of tumor mutational markers including KRAS and EGFR. There may exist, therefore, the opportunity to consolidate rather than further divide the treatment landscape in lung cancer, while improving safety and quality-of-life parameters.”
CRLX101 is a tumor-targeted nanopharmaceutical containing camptothecin, an inhibitor of both topoisomerase 1 and hypoxia-inducible factor-1 alpha (HIF-1a). CRLX101 is designed to concentrate in tumor tissue and tumor cells, prolonging drug exposure at the site of action. CRLX101 has demonstrated significant anti-tumor activity across a wide range of cancers in animal models and has been well tolerated in a recent 36 patient Phase 2a solid tumor clinical trial. CRLX101 is currently in Phase 2 clinical development. More information on CRLX101 clinical studies can be found at www.clinicaltrials.gov : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. .
Arrowhead Subsidiary Calando Pharmaceuticals Enters into License Agreement with Cerulean Pharma Inc.
Arrowhead Research Corp. (MM) (NASDAQ:ARWR)
Arrowhead Research Corporation (NASDAQ:ARWR) today announced that its Calando Pharmaceuticals, Inc. subsidiary has entered into a worldwide license agreement with Cerulean Pharma Inc. for Calando?s drug delivery platform, Cyclosert?, and associated clinical stage anti-cancer drug, IT-101. The agreement is part of Calando?s strategy to minimize its burn rate while retaining upside exposure via partnerships with high quality companies that will continue the development of Calando?s platforms and drug candidates. Importantly, this agreement does not include rights to develop and commercialize RNAi products or the clinical-stage RNAi candidate, CALAA-01, both of which Calando intends to partner separately.
Under the terms of the agreement, Cerulean made an upfront payment of $2.4 million to Calando and will make development milestone payments of up to $2.75 million if IT-101 progresses through clinical trials and receives marketing approval. If approved, Calando is also entitled to receive up to an additional $30 million in sales milestone payments, plus royalties on net sales.
As a platform delivery system, Cyclosert? may be utilized to generate a very large number of new drugs in addition to IT-101, and under the agreement with Cerulean, Calando will participate in any potential upside related to the development of other drugs using the delivery platform. For each new drug candidate that Cerulean is able to bring to market utilizing the Cyclosert? system, Calando will be entitled to $3 million in development milestone payments. Once these products reach the market, Calando could potentially receive an additional $15 million in sales milestone payments, plus royalties on net sales.
Commenting on the partnership, Dr. Christopher Anzalone, Arrowhead's President and Chief Executive Officer, stated, ?We strongly believe in IT-101 and the Cyclosert? platform, and this transaction goes a long way toward achieving our dual strategy of decreasing costs while working to monetize these potentially powerful assets. We believe that Cerulean will be a terrific partner given its focus on nanoparticle-based drugs, strong financial position, and high quality management team. We look forward to our mutual future success.?
?Calando?s cyclodextrin co-polymer based technology is founded on elegant chemistry, and the integration of this platform into our program fully leverages the expertise and capabilities that we have built,? said Dr. Oliver Fetzer, President and Chief Executive Officer of Cerulean. ?We look forward to applying the technology against a range of product opportunities, as well as further advancing IT-101 in the clinic.?