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Cytori Announces New U.S. Investigator Trial for Hip Osteonecrosis

5 days ago

SAN DIEGO, Nov. 13, 2017 (GLOBE NEWSWIRE) — Cytori Therapeutics, Inc. (CYTX) (“Cytori” or “the Company”) today announced a new investigator initiated U.S. clinical trial for hip osteonecrosis. Details of the trial can be assessed at https://clinicaltrials.gov/ct2/show/NCT03269409.

Cytori Cell Therapy™ technology is approved for use in many countries around the world and has been shown to be safe and clinically useful in many indications. As a result, besides Cytori sponsored clinical trials such as the STAR trial for scleroderma, on a highly selective basis, the Company partners with researchers, academic institutions, and private institutions to support Investigator Initiated Studies (IIS). In these unsolicited, independent clinical or scientific research programs, the sponsor generally provides the majority of the overall trial support while Cytori typically supplies the core cell therapy technology.

  • Recently, the U.S. FDA approved a trial of Cytori Cell Therapy in up to 25 patients with bilateral osteonecrosis of the hip (NCT03269409).  According to Cleveland Clinic, osteonecrosis of the hip is a rare disease that affects ~10,000-20,000 new patients each year in the U.S.  With osteonecrosis of the hip, disruption of the blood supply leads to loss of bone-forming cells within the hip resulting in progressive weakening and even death of the bone.  Over time this can progress to collapse of the hip bone, debilitating pain, and loss of mobility.  Hip decompression involves surgical removal of dead and dying bone to create a space in which new blood vessels and new bone can regenerate with the goal of restoring the structural integrity of the hip.  Despite this treatment, many patients go on to require complete hip replacement, often at a relatively young age.  This evolved from the combination of Cytori’s U.S. ACT-OA clinical trial (NCT02326961) and an earlier trial in Europe which reported evidence of new bone formation in patients receiving Cytori Cell Therapy in both  dental surgery and in osteoporotic fracture repair. This U.S. trial will assess the ability of Cytori Cell Therapy to provide benefit in patients with osteonecrosis of the hip.  The hope is that improved formation of new bone and blood vessels within the diseased hip will lead to more robust bone regeneration and thereby delay or even eliminate the need for later hip replacement surgery.  Cytori is supporting this IIS and believes that the 1stpatient may be enrolled by the end of 2017.
  • The SCLERADEC-2 trial in France (NCT02558543) of Cytori’s Habeo Cell Therapy™ for patients with hand dysfunction due to scleroderma continues to enroll, with 32 patients enrolled out of a target of up to 40.  Earlier this year, French regulatory authorities approved a 3rd center (Hôpital Saint-Louis, Paris) to add to the 2 centers (Assistance Publique Hôpitaux de Marseille and CHU de Rouen) currently treating patients.  The Marseille investigators anticipate completing enrollment by the end of 2017.  This trial has a 6 month follow-up period with the Cochin Hand Function Score at 3 months as the primary endpoint.  A novel aspect of SCLERADEC-2 is the inclusion of a crossover design in which, at the end of the trial, patients enrolled in the placebo arm can be treated with banked, cryopreserved Habeo Cell Therapy, harvested at the time of their initial enrollment in the study.  This arm will capture exploratory data that may be valuable for implementation of a future repeated treatment model for patients requiring only a single tissue harvest procedure for multiple therapies.
  • In September 2017, investigators from the Department of Urology at Nagoya University in Japan published the protocol for the presently enrolling ADRESU trial (NCT02529865) of Cytori’s ECCI-50 Cell Therapy in male patients with stress urinary incontinence (SUI) following radical prostatectomy.  ADRESU is an open-label, multi-center, single arm trial approved by Japan’s Ministry of Health, Labour and Welfare.  This trial is primarily sponsored and funded by the Japanese government, including by a grant provided by Japan’s Agency for Medical Research and Development.  The investigators have treated 35 of the targeted 45 patients. The investigators anticipate complete enrollment by the end of 2017 or early 2018.  ADRESU is the 1st trial of a regenerative treatment for SUI patients using ECCI-50 Cell Therapy performed under Japan’s Pharmaceutical Affairs Act.  Once the trial is completed successfully, Cytori intends to work with the team at Nagoya University to submit the ADRESU data to Japan’s Pharmaceuticals and Medical Devices Agency for approval to market this form of Cytori Cell Therapy for SUI.  ADRESU is a follow-up study of the previously published pilot study in this indication by the Nagoya team.  This pilot study data was subsequently confirmed and published by an independent team in South Korea, also using ECCI-50 Cell Therapy.

In addition to the aforementioned investigator initiated trials, many other investigators are currently conducting research with the Cytori Cell Therapy platform for a broad range of clinical indications:

Country Clinical Indication
Denmark Erectile Dysfunction (NCT02240823)
Denmark Lymphedema (NCT02592213)
France Crohn’s Disease (NCT02520843)
France Diabetic Foot Ulcer (NCT02866565)
France Vocal Cord Scarring (NCT02622464)
Japan Atherosclerosis Obliterans, Buerger’s Disease, Collagen Disease (UMIN000010143)
Japan Heart Failure (UMIN000009066)
Japan Intra Cerebral Hemorrhage
Japan Liver Cirrhosis (UMIN000022601)
Japan Stroke
Poland Acute Myocardial Infarction (link)
Poland Amyotrophic Lateral Sclerosis (NCT03296501)
Poland Breast Reconstruction
Poland Burn
Poland Diabetic Foot Ulcer
Russia Anterior Cruciate Ligament Partial Rupture (NCT02469792)
Russia Erectile Dysfunction (NCT02472431)
Russia Glaucoma (NCT02144103)
Russia Knee Osteoarthritis (NCT02219113)
Spain Meniscus Repair

In summary, these investigator initiated trials, typically performed at leading institutions in the U.S., Japan, and Europe, provide useful preliminary safety and efficacy data into novel therapeutic approaches for Cytori Cell Therapy. In fact, Cytori’s Habeo therapy was developed initially through an investigator initiated clinical trial. For more information about these trials, please visit Cytori’s website at cytori.com/researchers.  Furthermore, the results from some of these trials are listed on Cytori’s website at cytori.com/our-technology/#publications.

About Cytori

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.  As a result, Cytori Cell Therapy may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, statements regarding potential benefit to Cytori and timing of enrollment of investigator-initiated studies, the potential that improved formation of new bone and blood vessels will lead to more robust bone regeneration in patients with osteonecrosis, Cytori’s intention to work with Nagoya University to submit ADRESU data to Japan’s Pharmaceuticals and Medical Devices Agency for approval to market Cytori Cell Therapy for SUI and Cytori Cell Therapy’s potential to provide benefits across multiple disease states,are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of clinical studies and trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy), risks associated with clinical use of Cytori Cell Therapy in studies and trials not controlled by Cytori, risks to Cytori’s intellectual property portfolio (including the risk that independent investigators using Cytori’s technology or their employers may file for patent or other intellectual property that would not be owned by Cytori and may be competitive with or conflict with Cytori’s technology and pipeline) are described under the heading “Risk Factors” in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

CONTACT
CYTORI THERAPEUTICS 
Tiago Girao
+1.858.458.0900
ir@cytori.com

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