Micromet (MITI) Outlines Clinical Plans for Blinatumomab in ALL Feb 10, 2010 11:11AM

At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia, highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.

"We are very pleased with the strong support received from the medical community for the planned pivotal study in adult ALL," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "Based on our discussions with the EMEA on the study design, we plan to initiate patient enrollment in the EU in mid-2010." Â

Blinatumomab Development Program Highlights

Micromet provided additional details today on its plans to expand development of blinatumomab in leukemia:

  • EU pivotal study of blinatumomab in MRD-positive adult ALL – The Company plans to initiate a pivotal, single-arm study that will seek to enroll approximately 130 adult patients with MRD-positive ALL. Patients will receive up to four 4-week treatment cycles of blinatumomab at a dose of 15 micrograms/m2/day.  Key endpoints of the study include molecular complete response (MRD negativity) and relapse-free survival rate.  The Company currently anticipates enrolling patients in both the EU and US.  The Company plans to discuss its registration strategy for blinatumomab in the U.S. with the FDA later this year.
  • Development of blinatumomab in pediatric ALL – Based on experience from compassionate use utilization of blinatumomab in pediatric patients with relapsed/refractory ALL, the efficacy results in adult ALL and preliminary discussions with the EMEA, the Company is in the process of designing studies to facilitate expedited development of blinatumomab in this setting. The Company expects to finalize discussions with FDA and EMEA regarding its registration strategy in pediatric ALL during the course of 2010.
"Children resistant to available treatments for ALL are in dire need of new therapeutic options," said Arend von Stackelberg, M.D., Pediatric Oncology/Hemotology, Charite - University Clinic, Berlin, Germany. Â "The experience to date with blinatumomab in ALL is very encouraging and provides a strong rationale for expanded development in the pediatric setting."
  • Phase 2 study in relapsed/refractory adult ALL – The Company plans to initiate an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory ALL.  The primary endpoint of the study is hematological complete response rate.  The Company currently expects to initiate the study in mid-2010.
"Many adults with ALL who achieve complete remission will eventually relapse, making prevention of recurrence the best strategy for long-term patient survival," said Deborah Thomas, M.D., Associate Professor, Department of Leukemia, MD Anderson Cancer Center, Houston, Texas. "Novel therapeutic approaches for the treatment of this disease are therefore desperately needed."
  • Phase 2 study in relapsed/refractory Chronic Lymphocytic Leukemia€“ In collaboration with leading investigators in the EU and US, the Company plans to design and conduct an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory CLL. The Company currently plans to initiate patient enrollment by the end of 2010.
Webcast replay

A replay of the Company's R&D Day webcast, along with presentation slides, is available through a link on Micromet's web site at www.micromet-inc.com.


Toyota's (TM) Carter Says All Dealers Nationally Have Pedal Fix Feb 10, 2010 11:07AM

Speaking at the Chicago Auto Show, Toyota's (NYSE: TM) General Manager Bob Carter has said that all Toyota dealers nationally have issues with sticking accelerator pedals fixed. He said that dealers have repaired about 225,000 vehicles so far, and are repairing at a rate of 50,000 per day. He called the support dealers are showing the automaker overwhelming. The manager also said that Toyota is "completely focused" on fixing recent issues.

Shares of Toyota are up 1.3% to $75.59 today.


Northrop Grumman (NOC) Wins $26.2M Contract from U.S. Navy for Shipboard Radar Systems Feb 10, 2010 11:05AM

Northrop Grumman Corporation (NYSE: NOC) has received a full-rate production contract from the U.S. Naval Sea Systems Command for its AN/SPQ-9B shipboard radar systems, which will enhance detection and tracking of high-speed threats such as sea-skimming anti-ship missiles.

Under the fixed-price $26.2 million contract, Northrop Grumman's Naval and Marine Systems Division facility in Melville, N.Y., will supply four shipsets. The contract includes options that could bring the total value to $281.5 million. The options encompass a wide range of U.S. aircraft carriers, cruisers and amphibious assault ships, as well as the U.S. Coast Guard National Security Cutter.

The high-resolution X-band AN/SPQ-9B search radar sets will greatly improve the ability to defend against small high-speed threats, such as surface-skimming anti-ship missiles, and will be integrated with the ships' fire-control systems. The multi-mission radar systems are designed to detect small fast-moving targets in the presence of clutter from ocean waves, rain and land returns, as well as chaff and jamming.

"The AN/SPQ-9B radars will make an important contribution to the fleet's ability to operate in littoral waters where land and sea clutter often limit the tracking and detection capabilities of search radars," said Jeffrey L. Holloway, director of business development and marketing for Northrop Grumman's Maritime Systems business unit.


BT Group (BT) Awarded $370M Three-Year Contract Estension with The DWP Feb 10, 2010 10:08AM

BT Group plc (NYSE: BT) today announced it has been awarded a three-year contract extension with The Department for Work and Pensions (DWP), worth a minimum of $370 million, to provide voice, data network and contact centre solutions to the UK government department.

The deal builds on the existing contract between the DWP and BT Global Services, which has seen the networked IT services company help transform the department's voice and data networks by installing an IP (Internet Protocol) network and telephony solution, which regularly handles in excess of two million calls a day and at peak times has managed three million.

The contract extension, which closely fits with the Government's Public Sector Network (PSN) program, will see BT continue to provide converged IP local and wide-area networks, IP telephony and a range of conferencing services including video conferencing to a broad range of units, including Jobcentre Plus, the Pensions, Disability and Carers Service, Northern Ireland Social Security Agency and the Child Maintenance and Enforcement Commission. In addition to providing contact center technologies that have delivered considerable savings to units, such as Jobcentre Plus, BT has already delivered 118,000 IP telephony ports, 203,000 local area network connections, and 1,140 wide area network circuits across 1,140 DWP locations.

BT Global Services will now continue to build and maintain the DWP's contact center infrastructure, one of the largest in the world. BT has already rolled out nearly 22,000 seats for the department's virtual contact center, which at its peak is already handling in excess of 400,000 calls a day. In 2010 BT will take the number of contact center seats close to 30,000.

Sir Leigh Lewis, Permanent Secretary for the DWP, said: "Our relationship with BT has already played a major role in modernizing the Department's operations, enabling us to become even more customer focused and meet our customers' ever more complex communications needs. The extension of our contract with BT will ensure that we are able to further improve our service to our customers, reduce costs and move closer to our objective of meeting Public Sector Network program requirements.

Ian Livingston, Chief Executive Officer of BT, said: "We are delighted to have been awarded this contract extension with the Department for Work and Pensions. In the current economic climate, it's vital that UK citizens receive access to the best help and advice on jobs and benefits. Our award winning contact centre solutions are helping the DWP provide this and we are delivering networked IT services for citizens that will make a positive difference to their lives."

BT is working with the DWP to ensure that the network integrated communications and network services program closely meets the UK government's Public Sector Network (PSN) vision. The PSN program aims to create the effect of a single network infrastructure across Her Majesty's Government, reducing costs and introducing utility-like network-orientated computing services.


BT (BT) Awarded 3-year Contract Extension with The Department for Work and Pensions Worth minimum of $370 Million Feb 10, 2010 10:08AM

BT (NYSE: BT) has been awarded a three-year contract extension with The Department for Work and Pensions (DWP), worth a minimum of $370 million, to provide voice, data network and contact centre solutions to the UK government department.

The deal builds on the existing contract between the DWP and BT Global Services, which has seen the networked IT services company help transform the department's voice and data networks by installing an IP (Internet Protocol) network and telephony solution, which regularly handles in excess of two million calls a day and at peak times has managed three million.

[SM]


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