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Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today provided an update on the status of its research and development programs at the Piper Jaffray 25
th Annual Healthcare Conference in New York.
“We are pleased with the progress of our clinical pipeline and remain on track to achieve the goals we’ve previously outlined, including reporting interim data from the sotatercept trial in beta-thalassemia next week at the American Society of Hematology Annual Meeting,” said John Knopf, Ph.D., Chief Executive Officer of Acceleron. “Notably, our clinical development of dalantercept is progressing nicely and we’re excited to announce plans to initiate a phase 2 study in patients with hepatocellular cancer in the early part of 2014. We look forward to providing additional updates on our pipeline progress over the coming months.”
In the ongoing phase 2 clinical trial of dalantercept plus axitinib in patients with renal cell carcinoma, Acceleron has completed dose escalation and is now enrolling patients in the expansion stage of this study. Acceleron expects to achieve its previously stated goal of initiating the randomized, placebo-controlled stage of this trial by the end of the first quarter of 2014.
Based on the activity and tolerability observed in the ongoing renal cell carcinoma study in which patients are treated with the combination of dalantercept and axitinib, Acceleron has decided to initiate a combination study with dalantercept and sorafenib in patients with hepatocellular cancer (HCC). Acceleron previously stated plans to initiate its next dalantercept clinical trial by the end of the third quarter of 2014, but now expects to initiate this combination trial in HCC in the first quarter or early in the second quarter of 2014.
The Gynecologic Oncology Group (GOG) is conducting two monotherapy clinical trials to explore the single agent activity of dalantercept in ovarian and endometrial cancers. Both of these clinical trials are designed as two-stage studies. If there is sufficient clinical activity to potentially warrant development of dalantercept as a single agent in this first stage of the study, additional patients will be enrolled in the second stage of the trial. All of the patients have been enrolled in the first part of the ovarian cancer trial and the study is ongoing. In the endometrial cancer study, the GOG has determined that there was not sufficient activity to warrant development of dalantercept as a monotherapy for endometrial cancer and will not advance to the second stage of this trial.
Sotatercept and ACE-536
New interim clinical data from the phase 2 trial of sotatercept in patients with beta-thalassemia will be presented at 2013 American Society of Hematology Annual Meeting in New Orleans on December 9 th. The presentation will include new interim data from the 0.5 mg/kg dose group as well as data from the 0.1 and 0.3 mg/kg dose groups in this trial.
Sotatercept and ACE-536 clinical trials in beta-thalassemia and myelodysplastic syndromes are progressing on schedule.
Celgene and its collaborators continue to explore sotatercept in additional clinical studies including anemia of chronic kidney disease, Diamond-Blackfan anemia, myelofibrosis and multiple myeloma. Additionally, Acceleron and Celgene are exploring the preclinical activity of sotatercept and ACE-536 in other red blood cell disorders including Sickle Cell Disease.
Acceleron and Celgene remain on track to initiate a registration enabling study with either sotatercept or ACE-536 by the end of 2014 or the beginning of 2015.
Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.