These companies provided updates on their clinical trials and studies Thursday, attracting attention from investors and healthcare professionals.
Alkermes (ALKS) rose nearly 3% during the day following the release of results from a Phase 2 study and then rose another 6% after hours after positive Exenatide data. The company announced topline results from a phase 2 clinical study of ALKS 33 for the treatment of binge eating disorder. This randomized, double-blind, placebo-controlled, 12-week study was designed to assess the safety and efficacy of daily oral administration of ALKS 33 or placebo in 68 patients with binge eating disorder. While ALKS 33 demonstrated a significant reduction from baseline in the efficacy endpoint of self-reported weekly binge eating episodes, the reduction was not significantly different from that observed with placebo. Based on these results, the company has determined that future studies in the binge eating indication are less attractive than other potential alternatives and will not pursue further development of ALKS 33 in this area.
After hours Thursday, the company and its partners announced that results from a thorough QT (tQT) study that assessed the potential of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for Bydureon (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. Using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint, demonstrating that exenatide at and above therapeutic levels did not prolong the corrected QT (QTc) interval in healthy individuals. Further, the study found no relationship between QTc interval and plasma exenatide concentrations.
Idera Pharmaceuticals (IDRA) tumbled 7% after its partner announced a halt for a IMO-2055 trial. IMO-2055 is a TLR9 agonist for cancer treatment. Merck KGaA informed Idera that, based on increased incidence of neutropenia and electrolyte imbalances reported in its Phase 1 trial of IMO-2055 in combination with cisplatin/5-FU and cetuximab (Erbitux) in patients with first-line squamous cell carcinoma of the head and neck and subsequent re-evaluation of its clinical development program, Merck KGaA determined that it will not conduct further clinical development of IMO-2055 at this stage. Merck KGaA also informed Idera that it plans to complete its ongoing Phase 2 trial of IMO-2055 in combination with Erbitux in second-line patients with recurrent or metastatic SCCHN and to continue evaluating follow-on TLR9 agonists created by Idera under the collaboration.
Regeneron Pharmaceuticals (REGN) closed 2% higher after the company announced that its Zaltrap Phase 3 study will continue as planned. Regeneron said that the Phase 3 VENICE clinical trial evaluating the investigational agent Zaltrap (aflibercept) in the first-line treatment of patients with androgen-independent (hormone-refractory) metastatic prostate cancer will continue to completion as planned, with no modifications due to efficacy or to safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee following a planned interim analysis.
Baxter (BAX) was slightly higher after hours after it announced results of a Phase 2 study. The company said that new research published in Circulation Research found that injections of adult patients’ own CD34+ stem cells reduced reports of angina episodes and improved exercise tolerance time in patients with chronic, severe refractory angina (severe chest discomfort that did not respond to other therapeutic options). At six months after treatment, patients in the low-dose treatment group reported significantly fewer episodes of angina than patients in the control group (6.8 vs. 10.9 episodes per week), and maintained lower episodes at one year after treatment (6.3 vs. 11 episodes per week). Additionally, the low-dose treatment group was able to exercise (on a treadmill) significantly longer at six months after treatment, as compared with those in the control group (139 seconds vs. 69 seconds, on average). Angina episodes and exercise tolerance rates were also improved in the high-dose treated group at six months and at one year post treatment compared to the control group.
Accuray (ARAY) rose Thursday after announcing two studies highlighting the ability of its CyberKnife Robotic Radiosurgery System and its TomoTherapy Radiation Therapy System to treat a wide range of patients with lung cancer and lung metastases. The first, a study of 89 patients treated with the TomoTherapy System, found high rates of local tumor control with low levels of toxicity in a heterogeneous group of patients, many of whom had undergone previous surgery or conventional radiation therapy. In this study, two-year local progression free survival was 95%. This data suggests that image-guided SBRT with TomoTherapy provided an effective treatment option for this challenging group of patients with limited remaining alternatives.
The second study reported on a center's experience over the last five years using the CyberKnife System to treat 56 patients with metastatic lung tumors, several of whom had two or more tumors. Leveraging the CyberKnife System's real-time tumor tracking and automatic radiation beam correction, researchers were able to deliver high doses of radiation in just a few fractions to achieve high rates of tumor control with low rates of side effects regardless of tumor location.