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
28, 2013
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
|
California |
1-12830 |
94-3127919 |
|
(State or other jurisdiction |
(Commission File Number) |
(IRS Employer Identification No.) |
1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
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:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as “may, “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime’s periodic reports filed with the SEC under the heading “Risk Factors” and other filings that BioTime may make with the Securities and Exchange Commission. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, BioTime disclaims any intent or obligation to update these forward-looking statements.
Section 8 - Other Events
Item 8.01 - Other Events.
Enrollment in a safety trial evaluating Renevia™, a proprietary injectable matrix designed to facilitate the stable engraftment of transplanted cells, has been completed. Ten healthy volunteers each received one subcutaneous injection of Renevia™ without cells. The primary objective of the trial is to determine the safety, tolerability, and acceptance of Renevia™ without cells as determined by monitoring subjects for any post-treatment reactions. Examinations of the subjects after they received Renevia™ injections have shown that Renevia™ as well-tolerated by all subjects with no serious adverse events or subject withdrawals. A final check of the enrolled subjects for adverse events will be made four weeks after the injection.
The Renevia™ safety study was initiated on October 7, 2013 at The Stem Center in Palma de Mallorca, Spain, a patient therapy center, laboratory, and research facility located within the hospital Clinica USP Palmaplanas in Palma.
Subsequent clinical studies are planned to document the efficacy of Renevia™ as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to lipoatrophy, beginning with HIV related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin. Lipoatrophy is often a consequence of the normal aging process where the loss of fat in the cheeks or the back of the hands contributes to an aged appearance, but lipoatrophy can also be associated with trauma, surgery, and diseases, and is frequently suffered by HIV patients being treated with anti-viral drugs. According to published estimates, at least several hundred thousand patients in Europe, and a similar number in the U.S., are affected by lipoatrophy and related conditions such as lipodystrophy. These patients have very limited treatment options and these conditions therefore represent a significant unmet medical need. Our plans to proceed with additional clinical trials are subject to obtaining required regulatory and institutional approvals.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
|
Exhibit Number |
Description |
| 99.1 |
Press Release Dated October 28, 2013. |
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.
|
BIOTIME, INC. |
||||
|
Date: |
October 28, 2013 |
By: |
/s/ Michael D. West |
|
|
|
Chief Executive Officer |
|||
|
Exhibit Number |
Description |
| 99.1 |
Press Release Dated October 28, 2013. |
3
Exhibit 99.1
BioTime Reports Interim Results on Renevia™ Clinical Safety Trial
- Enrollment completed in first safety study of Renevia™ for dermatological applications -
- Two weeks following administration, Renevia™ appears safe and well tolerated with no serious unexpected adverse events observed to date -
ALAMEDA, Calif.--(BUSINESS WIRE)--October 28, 2013--BioTime, Inc. (NYSE MKT: BTX), today announced that William Tew, Ph.D., BioTime’s Chief Commercial Officer will provide an update on the development of Renevia™ at an investor meeting in New York City. In his presentation, Dr. Tew will announce that enrollment in a safety trial evaluating Renevia™, a proprietary injectable matrix designed to facilitate the stable engraftment of transplanted cells, is complete.
The ten healthy volunteers each received one subcutaneous injection of Renevia™ without cells. The primary objective of the trial is to determine the safety, tolerability, and acceptance of Renevia™ without cells as determined by monitoring subjects for any post-treatment reactions. Examinations of the subjects after they received Renevia™ injections have shown that Renevia™ was well-tolerated by all subjects with no serious adverse events or subject withdrawals. A final check of the enrolled subjects for adverse events will be made four weeks after the injection.
The Renevia™ safety study was initiated on October 7, 2013 at The Stem Center (www.stem-center.com) in Palma de Mallorca, Spain, an innovative patient therapy center, laboratory, and professional research facility located within the world-class hospital Clinica USP Palmaplanas in Palma. The Medical Director of the Center is Dr. Ramon Lull, MD, PhD, a leading expert on advanced regenerative therapies based on adipose technology. The Stem Center is owned and operated by the GID Group, Inc., Louisville, CO, USA.
Subsequent clinical studies are planned to document the efficacy of Renevia™ as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to lipoatrophy, beginning with HIV related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin. Lipoatrophy is often a consequence of the normal aging process where the loss of fat in the cheeks or the back of the hands contributes to an aged appearance, but lipoatrophy can also be associated with trauma, surgery, and diseases, and is frequently suffered by HIV patients being treated with anti-viral drugs. According to published estimates, at least several hundred thousand patients in Europe, and a similar number in the U.S., are affected by lipoatrophy and related conditions such as lipodystrophy. These patients have very limited treatment options and these conditions therefore represent a significant unmet medical need. BioTime’s plans to proceed with additional clinical trials are subject to obtaining required regulatory and institutional approvals.
Renevia™ is manufactured in the US in compliance with cGMP requirements and has been tested pursuant to ISO 10993 standards for implantable medical devices and shown to be biocompatible without adverse effects in animal studies.
About Renevia™
Renevia™ is a member of BioTime’s HyStem® family of hydrogels. These unique biomaterials are designed as matrices and scaffolds for tissue engineering and regenerative medicine applications. HyStem® hydrogels are distributed and sold worldwide by BioTime and its distributors for pre-clinical research. Clinical grade hydrogels are also available to support translational research and investigator initiated clinical studies. BioTime’s HyStem® technology is covered by two issued US patents with applications pending in the EU, Canada, Japan, and Australia.
About BioTime, Inc.
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime’s focus is on pluripotent stem cell technology based on human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”) cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime’s therapeutic and research products include a wide array of proprietary PureStem™ progenitors, HyStem® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (a HyStem® product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. In addition, BioTime has developed Hextend®, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend® is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:
Additional information about BioTime can be found on the web at www.biotimeinc.com.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com
CONTACT:
BioTime, Inc.
Lesley Stolz, PhD, 510-521-3390, ext 367
Executive
Vice President, Corporate Development
lstolz@biotimemail.com
or
Judith
Segall, 510-521-3390, ext 301
jsegall@biotimemail.com