CJEU Judge Agrees with ISCO and UK Court. Finds Parthenotes not Human Embryos. Opens way for Patents to be Approved

The Advocate General delivered his opinion this morning, essentially agreeing with the UK Court and ISCO that parthenotes, because they cannot become humans, should not be considered part of the definition of a human embryo.

The ruling is quite long, and contains a lot of analysis, follow the CJEU ruling link for the whole text, but appears to clear the way for ISCO's UK patents to now be approved.

Here's just the final conclusion paragraph.

V – Conclusion

80. In the light of the foregoing, I suggest that the Court should answer the question referred by the High Court of Justice, Chancery Division (Patents Court) as follows:

Unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity.

We'll have a longer press release when we've had a chance to read the full judgement.

Lifeline Cell Technology Expands Asian Distribution Network

CARLSBAD, CA – (Marketwired) - July 16, 2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company focused on therapeutic and research products, today announced that its subsidiary, Lifeline Cell Technology, has expanded its sales network by adding a number of new distributors in Asia and Oceania.

“Expanding our footprint in the fast-growing Asian marketplace has been a key strategic goal for the Company,” said Simon Craw, PhD, ISCO’s Executive Vice President of Business Development. “We already have several excellent distributors in Asia, and the in-house expertise and experience to make these new accounts successful. With these new distributors we have increased the number of countries where scientists can purchase our high-quality cell culture products.”

Lifeline Cell Technology (LCT) has expanded its overseas network by adding new distributors in several fast-growing territories including Korea, Taiwan, Australia, New Zealand and India. LCT develops, manufactures and commercializes over 130 human cell culture products. These products include frozen human adult or primary cells, adult stem cells and the reagents (called media) needed to grow, maintain and differentiate such cells. These human cell-based products are used by research scientists in pharmaceutical, academic and government research organizations to study human diseases and basic cell biology. LCT’s products provide value and quality by eliminating the need for scientists to source their own cells or develop their own media. Strict quality assurance ensures a high level of consistency and standardization, which along with a high level of customer service, makes LCT’s products the first choice for many scientists.

Lifeline Cell Technology is an important part of ISCO’s business model. As the commercially focused human cell subsidiary of ISCO, with a large catalog of existing products for sale, LCT complements ISCO’s R&D focus on developing novel stem cell-related therapeutic treatments for various unmet medical needs including Parkinson’s disease. LCT’s sales were $3.15 million for the previous four reported fiscal quarters (2Q 2013 through 1Q 2014), with 1Q 2014 sales having grown by 21% over 4Q 2013. We believe that increasing the international availability of LCT’s products will support continued sales growth.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs, expectations of LCT sales growth, and other opportunities for the company 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, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Contacts:

International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

Decision on ISCO's EU patent case (C-364/13) coming up next week.

Here's the link to the European Union Court of Justice website with the details of ISCO's up coming case.

Request for a preliminary ruling — High Court of Justice (Chancery Division) — Interpretation of Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ 1998 L 213, p. 13) — Meaning of human embryo — Meaning of ‘capable of commencing the process of development of a human being’ — Non-fertilised human ova whose division and development have been stimulated by parthenogenesis — Ova which cannot develop into a human being.

International Stem Cell Corporation Signs Agreement Including Certain Terms for a Definitive License Agreement with Rohto Pharmaceutical Co., Ltd. of Japan

CARLSBAD, CA - (Marketwired) - 07/08/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a research agreement with Rohto Pharmaceutical Company, Ltd. (“Rohto”), a global Japanese pharmaceutical company that develops new technology for the medical and cosmetics markets with approximately $1.3 billion in consolidated annual sales. Under this agreement, Rohto will evaluate stem cell-derived human cells owned and provided by ISCO in a number of pre-clinical animal models. If the research is successful and the parties agree on remaining terms, it is anticipated that a definitive license agreement will be signed at the end of the twelve-month period of this research agreement. Certain key terms of such a license agreement, including the target disease areas and intellectual property rights, have been established in the research agreement.

“We are delighted to have such an outstanding company work with us, and we believe that the potential for this agreement is significant,” said Dr. Simon Craw, EVP of Business Development at ISCO. “Under the terms of the agreement Rohto will begin working with our cells immediately and if the program is successful we may move to the next stage, signing a definitive license agreement. Such an agreement would significantly enhance our standing in a number of ways. Firstly, having diligently built up our scientific strength and patent portfolio over the last few years, it would both validate our research as well as our ability to generate licensing revenue from our proprietary platform. Secondly, by expanding the use of our technology into new areas beyond that which we can address alone, it would add value to the Company.”

Under the agreement ISCO will provide a number of differentiated human cells derived from the Company’s collection of pluripotent human stem cells known as UniStemCellTM. The Company has a track record of successfully demonstrating that human cells derived from UniStemCellTM are effective in animal models of various diseases and have the potential to be used as a basis for developing human therapies. The Company has adopted this approach successfully with a number of academic collaborators in the past.

About Rohto Pharmaceutical Company, Ltd.

Founded in 1899, Rohto Pharmaceutical is the second-largest consumer health company in Japan, and is a world leader in the manufacturing and marketing of pharmaceuticals, cosmetics, and skincare and healthcare products. Rohto has global operations and its products are available in more than 150 countries.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company 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, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, 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 company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

International Stem Cell Corporation to Present at BIO 2014

CARLSBAD, CA - (Marketwired), 6/17/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced that Executive Vice President Dr. Simon Craw, will present an overview of ISCO and its subsidiaries at the BIO 2014 conference on Tuesday, June 24th at 4:15 pm PDT. The conference is being held at the San Diego Convention Center.

BIO 2014 conference presentation details:

Date:                                                     Tuesday, June 24^th 2014

Time:                                                    4:15 pm PDT

Location:                                            San Diego Convention Center, San Diego, CA

Room:                                                  Mission Beach

Conference details:                       http://convention.bio.org/

BIO is the largest, most influential biotech meeting in the world, regularly attracting 15,000 of the most powerful biotech and pharm participants from 60+ countries.  This year at the San Diego Convention Center, June 23 – 26, 2014, the conference includes sessions and specialty forums covering 17 hot topics, 1,700+ exhibitors and BIO One-on-One Partnering^TM meetings with thousands of companies. If you have an interest in attending the conference or if you would like to arrange a meeting with International Stem Cell Corporation’s management team please contact the conference organizers.  To register for the event visit the conference website at http://convention.bio.org/register/

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell^TM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Contacts:

International Stem Cell Corporation

Dr. Simon Craw, Executive Vice President

Phone: 760-940-6383

Email: ir@intlstemcell.com

International Stem Cell Corporation Completes Important Study in Parkinson’s Disease Program

CARLSBAD, CA - (Marketwired) - 6/19/2014 , International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell based therapies, announced today the completion of the acute toxicity study of the Company’s proposed clinical product to treat Parkinson’s disease.  The recently completed IND-enabling study transplanting rodents with human neural stem cells, derived from ISCO’s proprietary parthenogenetic stem cell platform, showed that the cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans.  The program continues to progress according to the plan outlined with the FDA at the pre-IND meeting as reported in February 2014.  The Company intends to provide a further update early next quarter.

“I’m pleased that we have successfully achieved another important milestone in our Parkinson’s disease program.  A critical part of the development process, and the preparations for the IND submission, was to establish the highest tolerated dose of our clinical product in rodents,” said Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer.  “The results of this study show that the doses we will be proposing to the FDA in our phase I clinical study design for the treatment of Parkinson’s disease are well below the safety threshold.”

The study consisted of 19 immune deficient rodents divided into four cohorts, a control group and three treatment groups receiving escalating doses of human parthenogenetic neural stem cells (hPNSC).  Animals received stereotactic injections of hPNSC in the striatum and substantia nigra.  The rodents were observed for seven days post transplantation and demonstrated normal appearance and behaviors.  Necropsies showed no abnormal tissues or tumors after sacrifice.  Detailed immunohistochemical analysis demonstrated that the majority of the implanted cells survived the surgery and engrafted into the host brain tissue.

According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease.  The total direct and indirect cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells.  hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system.  The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCellTM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells.  hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system.  The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Contacts:

International Stem Cell Corporation

Dr. Simon Craw

Executive Vice President

Phone: 760-940-6383

Email: ir@intlstemcell.com

Dr. Ruslan Semechkin

Chief Scientific Officer

Phone: 760-940-6383

Email: ras@intlstemcell.com