Astellas Institute for Regenerative Medicine

Last updated
Astellas Institute for Regenerative Medicine
TypeSubsidiary
Industry Biotechnology
Founded1994
Headquarters Marlborough, MA
ProductsStem cell therapies for macular degeneration (human safety trial started in 2010 [1] ), retinis pigmentosa, glaucoma and corneal blindness [2]
Website Official website

Astellas Institute for Regenerative Medicine is a subsidiary of Astellas Pharma located in Marlborough, Massachusetts, US, developing stem cell therapies with a focus on diseases that cause blindness. It was formed in 1994 as a company named Advanced Cell Technology, Incorporated (ACT), which was renamed to Ocata Therapeutics in November 2014. [3] In February 2016 Ocata was acquired by Astellas for $379 million USD.

Contents

[4] [5]

History

Advanced Cell Technology was formed in 1994 and was led from 2005 to late 2010 by William M. Caldwell IV, Chairman and Chief Executive Officer. [6] Upon Mr. Caldwell's death on December 13, 2010, Gary Rabin, a member of ACT's board of directors with experience in investment and capital raising, assumed the role of Chairman and CEO. [7]

In 2007 the company's Chief Scientific Officer (CSO), Michael D. West, PhD, also founder of Geron [8] left Ocata to join a regenerative medicine firm, BioTime as CEO. In 2008, for $250,000 plus royalties up to a total of $1 million, the company licensed its "ACTCellerate" technology to BioTime. [9] Robert Lanza was appointed CSO. [10]

On November 22, 2010, the company announced that it had received approval from the U.S. Food and Drug Administration (FDA) to initiate the first human clinical trial using embryonic stem cells to treat retinal diseases. [11] A preliminary report of the trial published in 2012, [12] and a follow-up article was published in February 2015. [13]

In July 2014, Ocata announced that Paul K. Wotton, previously of Antares Pharma Inc (ATRS:NASDAQ CM), became President and Chief Executive Officer. [14]

On August 27, 2014, Ocata announced a 1-100 reverse stock split of its common stock. [15] Ocata was listed on NASDAQ in February 2015. [16]

Research

Macular degeneration

On November 30, 2010, Ocata filed an Investigational New Drug application with the U.S. FDA for the first clinical trial using embryonic stem cells to regenerate retinal pigment epithelium to treat Dry Age-Related Macular Degeneration (Dry AMD). [17] Dry AMD is the most common form of macular degeneration and represents a market size of $25–30 Billion in the U.S. and Europe. [18]

Stargardt's disease

In November 2010 the FDA allowed Ocata to begin a Phase I/II human clinical trial to use its retinal pigment epithelium cell therapy to treat Stargardt disease, a form of inherited juvenile macular degeneration. [19]

See also

Related Research Articles

<span class="mw-page-title-main">Macular degeneration</span> Medical condition associated with vision loss

Macular degeneration, also known as age-related macular degeneration, is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes. While it does not result in complete blindness, loss of central vision can make it hard to recognize faces, drive, read, or perform other activities of daily life. Visual hallucinations may also occur.

<span class="mw-page-title-main">Lipofuscin</span> Lipid-containing residue associated with aging

Lipofuscin is the name given to fine yellow-brown pigment granules composed of lipid-containing residues of lysosomal digestion. It is considered to be one of the aging or "wear-and-tear" pigments, found in the liver, kidney, heart muscle, retina, adrenals, nerve cells, and ganglion cells.

<span class="mw-page-title-main">Retinal implant</span>

A retinal implant is a visual prosthesis for restoration of sight to patients blinded by retinal degeneration. The system is meant to partially restore useful vision to those who have lost their photoreceptors due to retinal diseases such as retinitis pigmentosa (RP) or age-related macular degeneration (AMD). Retinal implants are being developed by a number of private companies and research institutions, and three types are in clinical trials: epiretinal, subretinal, and suprachoroidal. The implants introduce visual information into the retina by electrically stimulating the surviving retinal neurons. So far, elicited percepts had rather low resolution, and may be suitable for light perception and recognition of simple objects.

<span class="mw-page-title-main">Choroideremia</span> Medical condition

Choroideremia is a rare, X-linked recessive form of hereditary retinal degeneration that affects roughly 1 in 50,000 males. The disease causes a gradual loss of vision, starting with childhood night blindness, followed by peripheral vision loss and progressing to loss of central vision later in life. Progression continues throughout the individual's life, but both the rate of change and the degree of visual loss are variable among those affected, even within the same family.

<span class="mw-page-title-main">Drusen</span> Medical condition

Drusen, from the German word for node or geode, are tiny yellow or white accumulations of extracellular material that build up between Bruch's membrane and the retinal pigment epithelium of the eye. The presence of a few small ("hard") drusen is normal with advancing age, and most people over 40 have some hard drusen. However, the presence of larger and more numerous drusen in the macula is a common early sign of age-related macular degeneration (AMD).

Stargardt disease is the most common inherited single-gene retinal disease. In terms of the first description of the disease, it follows an autosomal recessive inheritance pattern, which has been later linked to bi-allelic ABCA4 gene variants (STGD1). However, there are Stargardt-like diseases with mimicking phenotypes that are referred to as STGD3 and STGD4, and have a autosomal dominant inheritance due to defects with ELOVL4 or PROM1 genes, respectively. It is characterized by macular degeneration that begins in childhood, adolescence or adulthood, resulting in progressive loss of vision.

<span class="mw-page-title-main">Robert Lanza</span> American medical doctor and scientist

Robert Lanza is an American medical doctor and scientist, currently Head of Astellas Global Regenerative Medicine, and Chief Scientific Officer of the Astellas Institute for Regenerative Medicine. He is an Adjunct Professor at Wake Forest University School of Medicine.

<span class="mw-page-title-main">Maculopathy</span> Term for pathological conditions effecting the macula

A maculopathy is any pathological condition of the macula, an area at the centre of the retina that is associated with highly sensitive, accurate vision.

<span class="mw-page-title-main">Foundation Fighting Blindness</span>

The mission of the Foundation Fighting Blindness is to fund research that will lead to the prevention, treatment and cures for the entire spectrum of retinal degenerative diseases, including retinitis pigmentosa, macular degeneration, Usher syndrome, Stargardt disease and related conditions. These diseases, which affect more than 10 million Americans and millions more throughout the world, often lead to severe vision loss or complete blindness.

Retinal gene therapy holds a promise in treating different forms of non-inherited and inherited blindness.

The Food and Drug Administration (FDA) approved the first clinical trial in the United States involving human embryonic stem cells on January 23, 2009. Geron Corporation, a biotechnology firm located in Menlo Park, California, originally planned to enroll ten patients with spinal cord injuries to participate in the trial. The company hoped that GRNOPC1, a product derived from human embryonic stem cells, would stimulate nerve growth in patients with debilitating damage to the spinal cord. The trial began in 2010 after being delayed by the FDA because cysts were found on mice injected with these cells, and safety concerns were raised.

Lampalizumab (INN) is an antigen-binding fragment of a humanized monoclonal antibody that binds to complement factor D; it was developed as a potential treatment of geographic atrophy secondary to age-related macular degeneration.

<span class="mw-page-title-main">Lineage Cell Therapeutics</span> Clinical-stage biotechnology company developing novel cell therapies

Lineage Cell Therapeutics, Inc. is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer.

Stephen H. Tsang is an American ophthalmologist and geneticist. He is currently a Professor of Ophthalmology, and Pathology and Cell Biology at Columbia University Irving Medical Center in New York.

Brolucizumab sold under trade name Beovu among others, is a humanized single-chain antibody fragment for the treatment of neovascular (wet) age-related macular degeneration (AMD).

<span class="mw-page-title-main">Robert MacLaren</span> British ophthalmologist

Robert E. MacLaren FMedSci FRCOphth FRCS FACS VR is a British ophthalmologist who has led pioneering work in the treatment of blindness caused by diseases of the retina. He is Professor of Ophthalmology at the University of Oxford and Honorary Professor of Ophthalmology at the UCL Institute of Ophthalmology. He is a Consultant Ophthalmologist at the Oxford Eye Hospital. He is also an Honorary Consultant Vitreo-retinal Surgeon at the Moorfields Eye Hospital. MacLaren is an NIHR Senior Investigator, or lead researcher, for the speciality of Ophthalmology. In addition, he is a member of the research committee of Euretina: the European Society of Retina specialists, Fellow of Merton College, in Oxford and a Fellow of the Higher Education Academy.

Geographic atrophy (GA), also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, choriocapillaris) which can lead to a loss of visual function over time. It is estimated that GA affects over 5 million people worldwide and approximately 1 million patients in the US, which is similar to the prevalence of neovascular (wet) AMD, the other advanced form of the disease.

Masayo Takahashi is a Japanese medical physician, ophthalmologist and stem cell researcher.

<span class="mw-page-title-main">Faricimab</span> Medication for macular degeneration

Faricimab, sold under the brand name Vabysmo, is a monoclonal antibody used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is the first bispecific monoclonal antibody to target both vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2). By targeting these pathways, faricimab stabilizes blood vessels in the retina. It is given by intravitreal injection by an ophthalmologist.

<span class="mw-page-title-main">Stem cell therapy for macular degeneration</span> Use of stem cells to treat macular degeneration

Stem cell therapy for macular degeneration is the use of stem cells to heal, replace dead or damaged cells of the macula in the retina. Stem cell based therapies using bone marrow stem cells as well as retinal pigment epithelial transplantation are being studied. A number of trials have occurred in humans with encouraging results.

References

  1. ↑ "Company seeks to test stem cells for blindness". Reuters. 2009-11-25.
  2. ↑ "Ocata website: Pipeline Overview". Archived from the original on 2015-01-09. Retrieved 2015-03-09.
  3. ↑ "Advanced Cell Technology Changes Name to Ocata Therapeutics". Ocata Therapeutics. 2014-11-14. Archived from the original on 2015-04-02. Retrieved 2015-04-25.
  4. ↑ "Astellas to acquire Ocata Therapeutics for $379M". GEN - Genetic Engineering and Biotechnology News. 2015-11-10. Retrieved 2020-04-29.
  5. ↑ "Astellas Announces Results of Tender Offer to Acquire All Outstanding Shares of Ocata Therapeutics and Changes to Subsidiaries - Feb 10, 2016". Astellas Pharma US, Inc. | News Room. Retrieved 2020-04-29.
  6. ↑ "Executive Profile". BusinessWeek.com. 23 March 2010. Archived from the original on October 18, 2010.
  7. ↑ "Advanced Cell Technology Senior Executive Officers". Advanced Cell Technology. Archived from the original on 2014-07-20. Retrieved 2014-08-13.
  8. ↑ "Bloomberg Longevity Economy Conference 2013 Panelist Bio". Archived from the original on 2013-08-03.
  9. ↑ "Press Release: ACTCellerate Technology Licensed to BioTime, Inc by Advanced Cell Technology".
  10. ↑ "New Method for Controversy Free Embryonic Stem Cells". Wired Science. 9 July 2008.
  11. ↑ "FDA approves second human embryonic stem cell trial". CNN.com. 22 November 2010.
  12. ↑ Schwartz, Steven D; Hubschman, Jean-Pierre; Heilwell, Gad; Franco-Cardenas, Valentina; Pan, Carolyn K; Ostrick, Rosaleen M; Mickunas, Edmund; Gay, Roger; Klimanskaya, Irina; Lanza, Robert (2012). "Embryonic stem cell trials for macular degeneration: A preliminary report". The Lancet. 379 (9817): 713–720. doi:10.1016/S0140-6736(12)60028-2. PMID   22281388. S2CID   2230787.
  13. ↑ Schwartz, Steven D; Regillo, Carl D; Lam, Byron L; Eliott, Dean; Rosenfeld, Philip J; Gregori, Ninel Z; Hubschman, Jean-Pierre; Davis, Janet L; Heilwell, Gad; Spirn, Marc; Maguire, Joseph; Gay, Roger; Bateman, Jane; Ostrick, Rosaleen M; Morris, Debra; Vincent, Matthew; Anglade, Eddy; Del Priore, Lucian V; Lanza, Robert (2015). "Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: Follow-up of two open-label phase 1/2 studies". The Lancet. 385 (9967): 509–516. doi:10.1016/S0140-6736(14)61376-3. PMID   25458728. S2CID   85799.
  14. ↑ "Cynata appoints Paul K Wotton to Board of Directors". www.biospectrumasia.com. Retrieved 2020-04-29.
  15. ↑ Seiffert, Don (18 November 2015). "Ocata's $379M acquisition leaves many small investors disillusioned". Boston Business Journal. Retrieved 2020-04-29.
  16. ↑ Ocata Therapeutics Approved for Listing on NASDAQ February 26, 2015
  17. ↑ "Advanced Cell Technology Files IND with FDA for First Clinical Trial Using Embryonic Stem Cells to Treat Dry AMD". Archived from the original on 2010-12-05. Retrieved 2010-11-30.
  18. ↑ "ACT Seeks FDA Approval For Stem Cell Study". Archived from the original on 2010-12-13. Retrieved 2010-11-30.
  19. ↑ "Advanced Cell Technology Receives FDA Clearance to Initiate Clinical Trials". Retina Today. Retrieved 5 April 2015.
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