NEW YORK and MELBOURNE, Australia, Nov. 12, 2014 (GLOBE NEWSWIRE) -- Mesoblast's Phase 2 trial results in degenerative disc disease were presented today at the North American Spine Society (NASS) Annual Meeting, the premier global conference for spine disease professionals. The key outcome of the trial was that a single injection of Mesoblast's proprietary allogeneic Mesenchymal Precursor Cell (MPC) product resulted in sustained improvements in pain and function at 12 months.
Investigator Dr Hyun Bae, who is Medical Director, Director of Education, Cedars-Sinai Spine Center, Cedars-Sinai Medical Center, Los Angeles; and Medical Director of the Spine Institute, Santa Monica, USA; presented summarized results on behalf of the trial investigators and stated: "There is a critical need for a non-surgical biologic approach to improve pain and function in the millions of patients suffering from chronic low back pain associated with disc degeneration. The results to date seem promising and I believe Mesoblast's stem cell therapy product could have the potential to transform the treatment of back pain."
Mesoblast's Phase 2 clinical trial enrolled 100 patients with moderate to severe low back pain persisting for more than 6 months and caused by early disc degeneration (less than 30% disc height loss, 83% below Pfirrmann Grade 5 by MRI). Patients were enrolled across 13 sites in the United States and Australia and randomized to receive direct intra-disc injection of saline (n equals 20), hyaluronic acid (HA, n equals 20), 6 million allogeneic Mesenchymal Precursor Cells (MPCs) in hyaluronic acid carrier (6M, n equals 30) or 18 million allogeneic MPCs in hyaluronic acid carrier (18M, n equals 30). Patients received the injection in the outpatient setting for a single painful degenerated lumbar level disc and are being assessed for safety and efficacy over a total of 36 months to evaluate long-term treatment effects.
The following key findings were presented to the NASS meeting:
- Allogeneic MPCs were well tolerated
- Both MPC doses showed improvement relative to controls for pain and functional improvement and reduced interventions
- Radiographic evidence demonstrating decreased abnormal vertebral movement, suggesting improvement in disc structure and stability
- MPC treated patients were three times more likely to achieve treatment success defined as clinically significant pain and function improvement without further intervention at both 6 and 12 months, when compared to controls
In line with recent discussions with the United States Food and Drug Administration (FDA), Mesoblast anticipates that it will commence the Phase 3 program by the end of this year which is expected to support product regulatory approvals.
Chronic Discogenic Low Back Pain (CDLBP)
Mesoblast's investigational product candidate MPC-06-ID is being developed to target the population of patients suffering from moderate to severe chronic low back pain due to moderately degenerated discs. The target patient population has exhausted conservative treatment options, may have failed epidural steroid injections to alleviate pain and has no treatment option other than invasive and costly surgical interventions. Over four million patients in the United States alone suffer from CDLBP. Physicians estimate a failure rate of 40% in surgically treated patients. Total costs of low back pain are estimated to be between US$100 billion and US$200 billion annually with two thirds of this amount attributed to patients' decreased wages and productivity.
Mesoblast Limited
Mesoblast Limited (ASX: MSB; USOTC: MBLTY) is a world leader in the development of biologic products for the broad field of regenerative medicine. The Company's proprietary adult stem cell technologies include its highly purified, immunoselected Stro- 1/Stro-3 positive Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs), Dental Pulp Stem Cells (DPSCs), and expanded Hematopoietic Stem Cells (HSCs). Mesoblast's protein technologies are based on factors derived from its proprietary cellular platforms, including Stromal Derived Factor-1 (SDF-1). Mesoblast's allogeneic or 'off-the-shelf' cell-based products are targeting substantial market areas of unmet medical need, including cardiac and metabolic diseases, inflammatory/immune-mediated conditions, oncology, and orthopedic diseases. Lead products under investigation are MSC-100-IV for steroid refractory acute Graft Versus Host Disease, MPC-06-ID for chronic discogenic lower back pain and MPC-150-IM for congestive heart failure, in partnership with Teva Pharmaceutical Industries Ltd. www.mesoblast.com