to the US Renal Data System, the Medicare cost of hemodialysis is $77,000 per patient, per year and 100,000 ESRD patients die in the U.S. each year. Tengion scientists have published and presented positive data on the effect of our approach on kidney function in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival.
Building on these results, Tengion is actively engaged in the next step in product development, defining product formulation and administration. The Company remains on track to request a pre-IND meeting with FDA by the end of the year.
"We are making progress with our Neo-Kidney Augment program and preclinical research, validating our formulation and delivery," said Tim Bertram, D.V.M., Ph.D., Executive Vice President, Science and Technology and Chief Scientific Officer. "We are on track to meet our goal of requesting a meeting with the FDA by the end of this year regarding the path to clinical trials with this development program."
In March, the Company announced the addition of two renal research and clinical experts, Ben Humphreys, M.D., Ph.D. and Giuseppe Remuzzi, M.D., F.R.C.P., from the Harvard Stem Cell Institute and Mario Negri Institute respectively, to its panel of Research & Development Advisors. This panel provides counsel to Tengion and engages leading researchers, clinicians, and patient advocates with the company as it advances its Organ Regeneration Platform™. The newest additions to the panel will work with Tengion in the area of renal function and CKD as the Company continues to advance its Neo-Kidney Augment program.
For the three months ended March 31, 2011, the Company reported an adjusted net loss of $6.5 million, or $0.41 per basic and diluted common share, compared with an adjusted net loss of $6.6 million, or $1.04 pPage: 1 2 3 4 5 6 7 Related biology technology :1
. Tengion Scientists Publish Positive Preclinical Findings With Neo-Organ Demonstrating Long-term Durability and Growth With Skeletal Maturation2
. Tengion Featured as Model of Innovation and Success at 35th Anniversary Celebration of the National Venture Capital Association3
. Tengion Announces Second Closing of Series C Financing4
. Tengion to Present at the Piper Jaffray 20th Annual Healthcare Conference5
. Tengion Presents New Data Supporting Key Urologic and Kidney Programs at 16th Annual Meeting of the International Society for Cellular Therapy6
. Tengion Presents New Data Supporting its Organ Regeneration Platform™ at 8th Annual Meeting of the International Society for Stem Cell Research7
. Tengion Appoints A. Brian Davis Chief Financial Officer8
. Tengion Announces Webcast of Analyst and Investor Meeting on October 27, 20109
. Tengion Appoints Richard E. Kuntz, MD to its Board of Directors10
. Tengion Presents New Large Animal Data Demonstrating Functional Kidney Regeneration at the American Society for Transplantation Annual Conference11
. Tengion to Present at the 13th Annual BIO CEO & Investor Conference and the Leerink Swann Hot Topics in Therapeutics Roundtable Conference