医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Ocata Therapeutics Announces Positive Results in Treating Macular Degeneration Using Fully Differentiated Stem Cell-Derived Retinal Pigment Epithelium (RPE) Cells in Asian Patients

2015年05月01日 AM01:30
このエントリーをはてなブックマークに追加


 

MARLBOROUGH, Mass.

Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, announced that a study has been published that includes top-line, positive results in Asian patients who were treated with Ocata’s proprietary RPE cells, manufactured using its DeltaCell™ Technology.

These new data support previously reported positive long-term safety and signs of visual improvement, as presented in The Lancet of October 15th, 2014. The Korean study published online in Stem Cell Reports features twelve months of post-transplant follow-up data from four Asian patients; two with Stargardt’s macular degeneration (SMD) and two with dry age-related macular degeneration (AMD).

“The results of this study conducted by CHA Biotech in Asian patients support the findings published in The Lancet in October 2014 and further underscores our leadership in regenerative ophthalmology,” said Paul K. Wotton, Ph.D., President and Chief Executive Officer. “The safe treatment of a total of forty two patients across multiple studies with this novel therapeutic approach in geographically distinct patient populations is encouraging. We look forward to the planned initiation of our comprehensive Phase 2 safety study in dry AMD and a pivotal study in SMD, two disabling diseases where there is no cure available today.”

In this study there was no evidence of adverse proliferation, tumorigenic behavior, ectopic tissue formation, or other serious safety issues related to the transplanted cells. Although designed as a safety study, visual acuity improved 9–19 letters in three patients and remained stable (+1 letter) in one patient. Vision was measured using the widely accepted standard for visual acuity testing, the Early Treatment Diabetic Retinopathy Study visual acuity exam.

Robert Lanza, M.D., Chief Scientific Officer of Ocata Therapeutics and co-senior author of the paper, commented, “These results support the potential safety and efficacy of hESC-derived cells in Asian patients and provides further evidence that hESC-derived cells could serve as a potentially safe new source for regenerative medicine.”

About Ocata Therapeutics, Inc.

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of regenerative ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.

About Age-related Macular Degeneration

Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the USA there are 1.8 million patients newly diagnosed with dry AMD which occurs when light-sensitive photoreceptor cells in the macula, located in the center of the retina, slowly break down, causing vision loss as a result. Photoreceptor breakdown is a consequence of loss or damage to the RPE layer. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven medical therapy for dry AMD and the projected number of people worldwide with age-related macular degeneration in 2020 is 196 million, increasing to 288 million in 2040 underscoring the urgent need for new treatments.

About Stargardt’s Disease

Stargardt’s macular degeneration is a form of juvenile macular degeneration that affects vision in children and young adults between the ages of six and 20, with a prevalence of approximately one in 10,000 people in the United States. It is an orphan disease and loss of vision is an inevitable aspect of SMD, with more than half of the patients experiencing vision loss in the range of 20/200-20/400. Like dry AMD, it occurs as a result of damage to the RPE layer and there are no treatments currently approved to prevent or slow the vision loss associated with SMD.

Forward-Looking Statements

All statements, other than historical facts, contained in this news release, including, Ocata’s plans to commence a comprehensive Phase 2 safety study in dry AMD and a pivotal study in SMD, hESC-derived cells’ potential as a safe new source for regenerative medicine, the planned objective and endpoints of the AMD trial and SMD trial, the planned objective and endpoints of the AMD trial and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history; Ocata’s need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.

CONTACT

Investors:
Westwicke Partners
John Woolford, 443-213-0506
john.woolford@westwicke.com
or
Press:
Russo
Partners
David Schull, 858-717-2310
david.schull@russopartnersllc.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • BioVectra与Keryx Biopharmaceuticals签署枸橼酸铁扩产协议
  • Eternity Healthcare Inc. Enters into Share Exchange Agreement with Guizho Tongren Healthy China Biotechnology Co. Ltd.
  • Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease
  • Chi-Med Initiates Fruquintinib U.S. Clinical Trials
  • Orthocell Granted European Tendon Regeneration Patent