Aastrom Biosciences Presents Clinical Results at The American Society of Hematology Meeting PR Newswire - December 07, 1998 10:30
Clinical Studies From Duke, Hackensack and Other Centers to Support European Marketing Efforts of the AastromReplicell(TM) System
MIAMI, Dec. 7 /PRNewswire/ -- Multi-center clinical trial results presented at the annual scientific meeting of the American Society of Hematology (ASH) have provided further evidence of the safety and clinical utility of the AastromReplicell(TM) Cell Production System (System) for stem cell transplantation, according to Aastrom Biosciences, Inc. (Nasdaq: ASTM). Results from four clinical studies conducted at multiple sites will be used to support European marketing efforts to begin later this year, and to establish the use of the AastromReplicell(TM) System for production of bone marrow and cord blood cells for transplantation.
The data presented at ASH were compiled from clinical studies evaluating the AastromReplicell(TM) System and the Company's two lead therapy kits for the production of bone marrow cells (SC-I Therapy Kit) or umbilical cord blood cells (CB-I Therapy Kit) for use in stem cell therapy in patients with cancer and other blood diseases. The AastromReplicell(TM) System is an automated clinical system designed to enable hospitals to produce patient-specific cells for use in the treatment of a broad range of diseases including cancer, infectious diseases, auto-immune diseases as well as cells used in the restoration of solid tissues. The AastromRepliCell(TM) System product line consists of an instrumentation platform that operates single use therapy kits.
"These new data substantially advance our development program for the AastromReplicell(TM) System in enabling new approaches in stem cell therapy for cancer patients," said R. Douglas Armstrong, Ph.D., President and CEO of Aastrom. "Most importantly, the studies begin to demonstrate the potential clinical benefits of the AastromReplicell(TM) System as we approach European market introduction of the product line for stem cell therapy. These potential benefits include improving patient care and enabling transplants to be performed when they otherwise might not have been feasible."
Advancements in Pediatric and Adult Cord Blood Transplantation
Cord blood is emerging as a promising new source of stem cells for use in therapy. Cord blood, which remains in the umbilical cord and placenta after child birth, is a rich source of stem cells that can be used to restore tissue destroyed by aggressive chemotherapy or radiation therapy used in the treatment of cancer and other diseases. However, there is a limited quantity of cells available from a standard cord blood collection, which generally restricts cord blood transplants to small patients and results in recovery times that can be quite long. Results from two studies were presented at ASH which evaluated the use of the AastromReplicell(TM) System to expand cord blood cells and to increase the quantity of cells available for transplant. These studies involved the transplantation of unmanipulated cord blood cells, followed 12 days later by a second transplant of cord blood cells expanded in the AastromReplicell(TM) System.
The first study, led by Joanne Kurtzberg, M.D., Director of the Pediatric Bone Marrow Transplant Program at Duke University Medical Center, was conducted to evaluate the clinical utility of the AastromReplicell(TM) System to increase the transplantation dose of cord blood cells for pediatric patients. The trial enrolled 25 patients and showed that use of the AastromReplicell(TM) System to increase the number of cells available for transplant could enable similar engraftment times to those seen when a larger dose of unexpanded cells is available and used. Although results are preliminary, the study also suggests an apparent improvement in the 100-day post transplant survival rates for the study patients when compared to historical control patients.
"The follow-up performed to date suggests that there may be a survival advantage for patients receiving a cell dose expanded ex vivo with the AastromReplicell(TM) System, as compared to our historical controls," said Dr. Kurtzberg. "Results of the trial support a continued study of the AastromReplicell(TM) System, as a means to increase the number of stem cells available for transplantation in our pediatric patients. We hope that this new technology will help these patients by offering a larger transplantation cell dose."
Low transplantation cell dose is particularly problematic for larger and older patients where cord blood transplantation is generally not attempted. Initial observations from a study conducted at Hackensack University and Loyola University Medical Center demonstrated that ex vivo expansion of cord blood cells using the AastromReplicell(TM) System, enabled adult patients to undergo a transplant when a sufficient cell dose of cord blood stem cells was otherwise unavailable. This study involved nine patients with advanced hematologic cancers who had undergone ablative therapy. The median weight of the patients transplanted was 74 kilograms (range 47 to 117 kilograms), and the data presented showed that four of the patients who received this treatment are alive at 56 to 292 days post-transplant.
These results may yield a new therapeutic approach for adult patients with otherwise incurable hematologic disorders. By being able to expand cord blood cells to larger quantities using the AastromReplicell(TM) System, patients may have a new treatment option when an acceptable bone marrow donor cannot be found.
Procedure Improvements in Stem Cell Transplantation
Results from another clinical study evaluated ex vivo expanded bone marrow cells in combination with sub-therapeutic doses of peripheral blood stem cells (PBSC) in cancer patients who had undergone extensive chemotherapy. The study, conducted by clinicians at Hackensack University, Loyola University Medical Center and the South Texas Cancer Institute, involved 31 patients and evaluated the effect on hematopoietic recovery rates by combining ex vivo expanded bone marrow cells with low doses of PBSC collected in a single blood apheresis collection.
The study demonstrated that the combination of ex vivo expanded bone marrow cells with PBSC collected in a single blood apheresis procedure resulted in hematopoietic recovery rates similar to that reported for patients receiving significantly higher doses of PBSC, typically collected in multiple apheresis procedures. In these studies, median recovery times to absolute neutrophil count greater than 500 and platelets greater than 20,000 for patients receiving 0.5 to 0.7 x 10(6) CD34+ cells/kg collected from a single blood apheresis procedure, plus ex vivo expanded cells were 10 and 11 days, respectively.
"The ability of the, AastromReplicell(TM) System procedure to reduce the required PBSC dose and corresponding number of blood apheresis procedures, concurrent with offering the patient the opportunity for an optimal recovery, may address several of the unmet needs in stem cell transplantation," said Dr. Armstrong. "The addition of ex vivo expanded bone marrow to the sub-therapeutic doses of PBSC evaluated in this study, resulted in transplant recoveries that were similar to patients who receive a dose of PBSC alone that is as much as ten times greater. Additionally, decreasing the required dose of PBSC and the number of apheresis procedures using the AastromReplicell(TM) System procedure may potentially decrease the risk of tumor cell contamination and enable transplants for patients where otherwise only sub-therapeutic PBSC collections could be completed."
Data to Support European Market Introduction
In October of this year Aastrom announced that it obtained its initial approval to affix the CE Mark to the AastromReplicell(TM) System instrumentation platform. This instrumentation platform is designed to operate therapy-specific kits including the Company's lead therapy evaluated in the trials reported at ASH. Approval to affix the CE Mark to the remaining components of these therapy kits is pending. Upon receipt of these remaining approvals and completion of production manufacturing of the AastromReplicell(TM) System, the Company plans to initiate marketing activities in Europe.
Aastrom Biosciences, Inc. is pioneering the development of proprietary clinical systems including the AastromReplicell(TM) System, a first of its kind product, to enable physicians and patients greater accessibility to cells used for therapy. The AastromReplicell(TM) System product line consists of an instrumentation platform that can operate a growing number of patient specific therapy kits tailored to each cell therapy application. Aastrom has received patents covering methods and devices for the ex vivo production of human stem and other types of cells, as well as for the genetic modification of stem cells. The AastromReplicell(TM) System is an experimental device under development, and is not available for sale in the U.S. at this time.
This document contains forward-looking statements, including without limitation, statements concerning product development and commercialization objectives and potential advantages of the AastromReplicell(TM) System, which involve certain risks and uncertainties. The forward-looking statements are also identified through use of the words "anticipates," "believes," "expects," "plans," and other words of similar meaning. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors than may result in differences are the results obtained from clinical trial and development activities, regulatory approval requirements, risks associated with market acceptance of the Company's products, and the availability of resources. These and other significant factors are discussed in greater detail in Aastrom's Annual Report on Form-10K and other filings with the Securities and Exchange Commission.
SOURCE Aastrom Biosciences, Inc.
/CONTACT: Todd Simpson, Sr. VP Finance & Administration, CFO of Aastrom
Biosciences, Inc. 734-930-5777 or Francesca T. DeVellis of Feinstein Kean
Partners Inc., 617-577-8110/
/Web site: aastrom.com
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