UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event
Reported): October 14, 2014
ADVANCED
CELL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Delaware |
000-50295 |
87-0656515 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
33 Locke Drive, Marlborough, Massachusetts |
01752 |
(Address of Principal Executive Offices) |
(Zip Code) |
Registrant's Telephone Number, Including
Area Code: (508) 756-1212
_____________________________________
(Former Name or Former Address, if Changed
Since Last Report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On October 14, 2014, Advanced Cell Technology, Inc. (the “Company”) issued a press release announcing the October 14,
2014 publication online by The Lancet, of results from a Company-sponsored Phase 1/2 clinical trial regarding the
safety and tolerability of sub-retinal transplantation of human embryonic stem cell-derived retinal pigment epithelial cells transplanted
into patients with Stargardt’s macular dystrophy and dry age-related macular degeneration.
A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference.
Item 9.01 Financial Statement and Exhibits.
Exhibit
Number Description
Exhibit
Number |
|
Description |
|
|
|
99.1 |
|
Press Release Dated October 14, 2014 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Advanced Cell Technology, Inc. |
|
|
Date: October 15, 2014 |
By: |
/s/ Edward Myles |
|
|
Edward Myles
Chief Operating Officer & Chief Financial Officer |
EXHIBIT INDEX
Exhibit
No. |
|
Description |
|
|
99.1 |
|
Press Release, dated as of October 14, 2014 |
Exhibit 99.1
ACT Announces Positive Results from Two
Clinical Trials Published in The Lancet Using Differentiated Stem Cell-Derived Retinal Pigment Epithelium (RPE) Cells for
the Treatment of Macular Degeneration
Phase 1/2 Clinical Trials of RPE Cells
for the Treatment of Dry Age-Related Macular Degeneration and Stargardt’s Macular Degeneration Show Positive Long
Term Safety Results and Signs of Visual Improvement
ACT
to Host a Conference Call on Wednesday, October 15, 2014 at 4:30 PM Eastern Time. Interested Parties may access the call live by
dialing (888) 264-3177 and using Conference ID 18428590.
A Webcast is available at http://engage.vevent.com/rt/act~advancedcelltechnology101514
MARLBOROUGH, Mass. – October 14th, 2014 − Advanced
Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative ophthalmology, announced today that
Phase 1/2 clinical data published online in The Lancet demonstrate positive long-term safety results using ACT’s proprietary
Retinal Pigment Epithelium (RPE) cells for the treatment of Stargardt’s macular degeneration (SMD) and dry age-related macular
degeneration (AMD). The publication features data from 18 U.S.-based patients with at least six months of post-transplant follow-up.
“These study results represent an important milestone
and strengthen our leadership position in regenerative ophthalmology” said Paul K. Wotton, Ph.D., President and Chief Executive
Officer. “We would like to thank the patients for their willingness to participate in these studies. Our findings underscore
the potential to repair or replace tissues damaged from diseases. We plan to initiate comprehensive Phase 2 clinical trials for
the treatment of both AMD and SMD, two disease states where there is currently no effective treatment.”
These two studies provide the first evidence of the mid- to
long-term safety, survival, and potential biologic activity of pluripotent stem cell progeny into humans with any disease. In addition
to showing no adverse safety issues related to the transplanted tissue, anatomic evidence confirmed successful engraftment of the
RPE cells, which included increased pigmentation at the level of the RPE layer after transplantation in 13 of 18 patients.
Robert Lanza, M.D., Chief Scientific Officer of ACT
and co-senior author of the paper, commented, “Diseases affecting the eye are attractive first-in-man applications for
this type of investigational therapy due to the immune-privileged nature of the eye. Despite the degenerative nature of
these diseases, the vision of 10 of 18 patients showed measurable improvement at the six month follow up, after
transplantation of the RPE cells. Furthermore, the cells have been well tolerated for a median period of 22 months with two
of the patients treated more than three years ago. We are pleased that there have been no serious safety issues attributable
to the cells observed in any of the patients.”
Vision was measured using the widely accepted standard for visual
acuity testing, the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity exam.
Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at
the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute, principal investigator
and lead author of the publication said “The data published in The Lancet support the potential safety and biological
activity of stem cell-derived retinal tissue. Once again, surgical access to the subretinal space has proven safe. However, for
the first time in humans, terminally differentiated stem cell progeny seem to survive, and do so without safety signals. Combined
with the functional signals observed, these data suggest that this regenerative strategy should move forward. This is a hopeful
and exciting time for ophthalmology and regenerative medicine.”
About the Trials
The SMD and dry AMD trials are prospective, open-label studies
designed to evaluate the safety and tolerability of human embryonic stem cell (hESC)-derived RPE cells following sub-retinal transplantation
into patients at 12 months, the studies’ primary endpoint. Three dose cohorts were treated for each condition in an ascending
dosage format (50,000 cells, 100,000 cells, and 150,000 cells). Both the SMD and dry AMD patients had subretinal transplantation
of fully-differentiated RPE cells derived from hESCs. In addition to the two clinical trials in the U.S., ACT is carrying out a
Phase 1/2 clinical trial of hESC-derived stem cells for the treatment of SMD in the United Kingdom.
About Age-related Macular Degeneration
Age-related macular degeneration is the leading cause of vision
loss in people over the age of 50, with late stage AMD affecting about 30 million people worldwide. Dry AMD, accounts for 90 percent
of all AMD and occurs when light-sensitive cells in the macula, located in the center of the retina, slowly break down, causing
vision loss. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven
medical therapy for dry AMD. Including the earlier stages of disease, 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. Loss of vision is an inevitable aspect of SMD, with more than half of patients experiencing vision loss in
the range of 20/200-20/400. Like dry AMD, there are no treatments currently approved to prevent or slow the vision loss associated
with SMD.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., (ACT) is a clinical stage biotechnology
company focused on the development and commercialization of regenerative medicine and cell therapy technology. ACT’s most
advanced products are in clinical trials for the treatment of dry age-related macular degeneration, Stargardt’s macular degeneration
and myopic macular degeneration. ACT’s preclinical programs involve cell therapies for the treatment of other ocular disorders
and for diseases outside the field of ophthalmology, including autoimmune, inflammatory and wound healing-related disorders. ACT’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.advancedcell.com
Forward-Looking Statements
All statements, other than historical facts, contained in
this news release, including statements regarding the relevance and applicability of clinical trials, potential new applications
of and expanded indications covering ACT’s technology, the effect of ACT’s products on the medical needs and quality
of life of study subjects or other patients, ACT’s potential product pipeline and development efforts, and any other statements
about ACT’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 ACT has no product revenue and no
products approved for marketing; ACT’s limited operating history; the 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 ACT’s intellectual
property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials
may not support the Company’s drug candidate claims; even if approved, the risk that physicians and patients may not accept
or use ACT’s products; ACT’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 ACT’s periodic reports, including the Quarterly Report
on Form 10-Q for the three and six months ended June 30, 2014. Forward-looking statements are based on the beliefs, opinions,
and expectations of ACT’s management at the time they are made, and ACT 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 ACT’s management at the time they are made, and ACT 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 ACT’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
Tony Russo, Ph.D., 212-845-4251
tony.russo@russopartnersllc.com
Editor’s Note: Photos and b-roll are
available on request. Please contact
David.Schull@russopartnersllc.com