BASKING RIDGE, N.J., April 18, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a leading cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic product pipeline, announces that the Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) thirty-day review period of the Company’s Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Company’s CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed without further comment from the PMDA. Accordingly, Caladrius is allowed to proceed with the trial when ready. The Company is seeking a partnership in order to pursue this trial, and is currently in advanced discussions with potential licensing partners. Pending consummation of a partnering agreement, Caladrius expects that the pivotal trial could initiate as early as late 2016.
The Company believes the study design is sufficient to achieve conditional approval for CLBS12 in Japan for the treatment of CLI. The agreed trial is a 35-patient Phase 2, prospective, randomized, controlled, multicenter study in patients with no-option CLI conducted in Japan. Those patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34+ cells (CLBS12) through intramuscular injection in addition to standard of care. Patients randomized to the control arm will receive standard of care pharmacotherapy alone.
“We are pleased that our interactions with the PMDA have led to the design of a relatively small and, we believe, low risk trial that could significantly advance CLBS12 and the Company’s CD34 asset,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “We look forward to achieving a partnership to enable the launch of this pivotal Phase 2 trial in Japan. CLI is just the entry-point to explore the broader applicability of the CD34 platform therapy, which could potentially be effective in the treatment of chronic heart failure or dilated cardiomyopathy.”
Caladrius has decided to aggressively pursue this registration pathway in Japan largely due to the recent Regenerative Medicine Law passed in November 2014. The legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate safety and the likelihood for efficacy.
“Based on the substantial clinical data from four prior trials in critical limb ischemia and claudication, we believe that CD34 cell therapy is not only safe, but can help improve quality of life and potentially treat patients with this serious and life-threatening condition, which we intend to demonstrate through this pivotal study,” said Dr. Atsuhiko Kawamoto, principal investigator for this pivotal Phase 2 trial for CLBS12.
Dr. Kawamoto is the Director of the Unit of Regenerative Medicine and Leader of the Vascular Regeneration Research Group at the Institute of Biomedical Research and Innovation in Kobe, Japan. He is also the Vice Director of the Translational Research Informatics Center at the Foundation for Biomedical Research and Innovation.
CD34 cells have been investigated in clinical studies encompassing over 700 patients with over 400 receiving CD34 cell therapy exposure. The scientific rationale for CLBS12 is based on previous studies of autologous CD34 cell therapy for no-option CLI patients in both Japan and the U.S. From those previous studies, researchers found that CD34 cell injection was safe, led to improvement in CLI-free status and improved amputation-free survival and other clinical parameters.
About Critical Limb Ischemia
Critical limb ischemia is a severe obstruction of the arteries which markedly reduces blood flow to the extremities (hands, feet and legs). CLI is an advanced stage of peripheral artery disease, which results from a progressive thickening of an artery’s lining (caused by a build-up of plaque). It can lead to pain, skin ulcers and sores, and if not successfully addressed, eventually amputation. One year after CLI onset, only 50% of patients will remain amputation-free (though may still be symptomatic), 25% will require a major amputation and the remaining 25% will have died. Caladrius’ CD34 cell approach, if successful, could aid patients who currently have no other therapeutic options for this devastating disease.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. For more information, visit www.caladrius.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the consummation of a partnership agreement to initiate a pivotal trial in critical limb ischemia and the achievement of conditional approval for CLBS12 in Japan based on such a trial. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
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