Alchemia Ltd., of Brisbane, Australia, said it expected to report the top-line results from a pivotal phase III trial of HA-Irinotecan in metastatic colorectal cancer before the end of the third quarter this year.
Brainstorm Cell Therapeutics Inc., of New York and Petach Tikvah, Israel, said the first patient has been enrolled in its phase II amyotrophic lateral sclerosis trial at Massachusetts General Hospital in Boston. The study is designed to evaluate the safety and efficacy of transplantation of autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF or Nurown) in 48 ALS patients.
Cubist Pharmaceuticals Inc., of Lexington, Mass., said the positive results from ESTABLISH-2, a pivotal phase III trial of the investigational antibiotic Sivextro (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI), have been published online in The Lancet Infectious Diseases. Sivextro is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious infections caused by certain gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus. The published data are based on one of the two global studies (ESTABLISH-1 and ESTABLISH-2), which met the primary and secondary endpoints defined by the FDA and European Medicines Agency. The clinical trials enrolled 1,333 people in the U.S., Europe and other regions worldwide. Cubist is seeking approval for Sivextro in ABSSSI and the FDA accepted an NDA for Priority Review, assigning a PDUFA action date of June 20.
Tolero Pharmaceuticals Inc., of Salt Lake City, reported at ASCO positive interim results from an ongoing, randomized phase II trial of its lead drug candidate, alvocidib, in combination with cytarabine plus mitoxantrone for previously untreated acute myeloid leukemia (AML) patients. In this study patients with newly diagnosed, poor and intermediate risk AML, experienced complete response rates of 70 percent versus 46 percent with the standard of care (p=0.003).
Vertex Pharmaceuticals Inc., of Cambridge, Mass., posted the design of an open-label, first-in-human study of cancer compound VX-970 on clinicaltrials.gov. The trial, which plans to enroll approximately 105 participants, will evaluate safety, tolerability and pharmacokinetics of VX-970, in combination with cisplatin and gemcitabine and in combination with gemcitabine alone, in advanced solid tumors. Secondary outcome measures include objective tumor response and progression-free survival.