GNBT Reports Favorable Phase III Data
Generex Biotech (GNBT 0.40) announced that findings based on in-process data for subjects that completed the 6-month treatment phase of the study demonstrate several favorable comparisons to injectable insulin.
The company said that these reported trends and outcomes are preliminary only. Once approximately 450 subjects are enrolled in the study, a formal interim analysis of the collected data is planned.
MITI Presents Update on MT110
Micromet (MITI 6.02 -0.23) announced the presentation of updated interim results from a Phase 1 trial of the Company's BiTE antibody MT110 in patients with advanced solid tumors. MT110 is designed to direct a patient's T cells, the immune system's most potent killer cells, against cancer cells that express the epithelial cell adhesion molecule (EpCAM). As of May 2010, 28 patients with locally advanced, recurrent or metastatic colorectal, gastric, and lung cancer have been treated with MT110 at dose levels ranging from 1 to 24 micrograms per day, in four week treatment cycles.
The company reported that 62% of the enrolled patients had received more than three prior lines of chemotherapy. Out of 22 patients evaluable for response, disease stabilization was observed in nine patients, with a median duration of 91 days. Consistent with the BiTE mode of action, investigators observed redistribution and expansion of T cells in blood, and infiltration of T cells into tumor tissue. The majority of adverse events were Grade 1 and 2, including fever and nausea.
CPA Reports YoY Growth in May ASM and RPM Data
Copa Holdings (CPA 48.60 -0.29) announces monthly traffic statistics for May 2010; ASMs up 6.1% year-over-year; RPMs up 20.9% year-over-year.
EXEL Reports PI3K Inhibitor XL147 Data
Exelixis (EXEL 4.98 -0.10) reported updated interim data from three ongoing trials of XL147 (SAR245408), a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K).
Exelixis is developing XL147 with sanofi-aventis (SNY). For XL147 in Patients with Advanced Malignancies, 75 patients were evaluable for antitumor activity. Pharmacodynamic (PD) analyses indicate robust inhibition of PI3K and ERK pathway signaling in tumors were observed.
In a separate press release, the company said the pathway also has been implicated as a mediator of resistance to agents targeting epidermal growth factor receptor (EGFR) family members. The presentations will be made at the 2010 Annual Meeting of the American Society of Clinical Oncology, which is being held June 4-8 in Chicago. Exelixis is developing XL147 with sanofi-aventis (SNY).
OII Lowers FY10 EPS Guidance
Oceaneering International (OII 43.14 +0.25) issued fiscal year 2010 earnings guidance overnight, which was below consensus.
The company issued earnings guidance of $2.80 to $3.10 per share, well below the $3.48 Thomson Reuters consensus. The company estimates that the impact of the six-month moratorium on deepwater permitting and drilling activities in the Gulf of Mexico will be reduction of $0.45 to 2H10 results.
OII said the reduced earnings guidance presumes declining use of ROVs in the GOM during 2H10, lower demand for IWOCS and pipeline repair system Subsea Product lines, and less deepwater vessel installation work for Subsea Projects.
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