Scottsdale 8/6/2015 8:00:00 PM
News / Finance

QualityStocks News - International Stem Cell Corp. (ISCOD) Prepares To Up-List, Tightens Share Structure Ahead of Landmark Parkinson’s Clinical Trial

QualityStocks would like to highlight International Stem Cell Corporation (OTCBB: ISCO), researching 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). The company is focused on using these stem cells to treat diseases of the eye, the nervous system, and the liver, where cell therapy has been proven clinically yet is limited by the availability of safe immune-matched human cells or tissue.

In the company’s news:

With the success of its nine-month GLP safety (tumorigenicity) and biodistribution animal model study in Parkinson’s Disease (PD) showing a completely clean record, as zero tumor growth was observed across a batch of 300 rodents injected with the company’s ethically and proprietarily-derived human neural stem cells (hpNSCs), International Stem Cell Corp. has subsequently taken a major step to increase the company’s market presence and up-list to a major exchange, announcing a reverse stock split in order to tighten the overall share structure. Since the July 29 split announcement, the company’s ticker has been ISCOD, and it will remain so until the typical period of approximately 20 days has elapsed.

The recently completed nine month GLP safety study, which capitalizes on a long track record of successfully demonstrated results stretching back to such examples as the 2013 work with Duke University’s Clinical Research Institute, was the last step needed for International Stem Cell to secure the previously announced landmark phase 1/2a clinical trial in PD with the Australian Therapeutic Goods Administration via the company’s recently-formed Australian subsidiary, Cyto Therapeutics Pty Ltd. The company has quite a preclinical dataset to back up its novel approach to treating PD with injected hpNSCs, which are self-renewing multipotent precursor cells to the main types of cells that make up the CNS (central nervous system), created using the company’s proprietary parthenogenetic technology, which chemically differentiates unfertilized human eggs (oocytes) into pluripotent stem cells (capable of giving rise to many different cell types).

This extensive preclinical dataset the company has thus far amassed, showing zero evidence of tumor formation at even high dosages (including proof-of-principle PD cohort studies and additional studies focused on safety), combined with direct evidence that injected hpNSCs exhibit a neuroprotectant capacity, as well as an ability to actively recover neurons and address the core motor function symptomatology of PD characterized by dopamine deficiency, is an extremely positive forward indicator to investors. International Stem Cell Corporation has been steamrollering forward with incredible momentum in 2015, ever since the announcement in December of last year that the EU’s Court of Justice ruled in favor of the company’s core technology patent applications, declaring them to be effectively outside the scope of prohibitions on patenting embryonic stem cells, due to a laser-like focus on only ethical derivation of non-embryonic stem cells from unfertilized eggs. Ethically-derived sourcing is a key advantage for International Stem Cell Corporation, especially in the current environment, where a political and ethical debate about stem cell technology is heating up.

Highlights for the company so far this year include solid Q1 results reported in March, showing a 74 percent uptick in gross margins on the strength of a 76 percent increase in operating income from the company’s cosmeceutical and biomedical commercialization. Income growth to $1.62 million in revenue was led by a 5 percent sales jump at the company’s Lifeline Skin Care subsidiary, which specializes in providing rejuvenating skin care products based on nanosphere-enscapsulated proteins extracted from parthenogenetic stem cells. Additionally, the company made waves in the regenerative therapy industry with a talk given in May at the International Society for Cellular Therapy’s (ISCT) annual meeting by the company’s CSO, Ruslan Semechkin, Ph.D., highlighting the potential of hpNSCs for treating PD. The ISCT is the leading global association focused on innovative preclinical and translational cell therapy product development, and Dr. Semechkin’s talk on hpNSC therapy left a lasting impression on key industry participants who attended the Regeneration and Nervous System Repair session at the organization’s 21st annual meeting in Las Vegas.

This move to reverse split the common stock and up-list to a major exchange comes at an auspicious time for International Stem Cell Corporation as the company rockets towards commercialization of a potentially genuine treatment option for PD sufferers and their families. With GlobalData estimates on the PD treatment market running into the $5.3 billion range within the next seven years alone, growing at a compound annual rate of over four percent, International Stem Cell Corporation is poised to become one of the big names in PD treatment, especially considering the company’s ample IP position. The company has made a herculean effort thus far to globally secure its core technology, as well as specific pluripotent human parthenogenetic stem cell (hpSC) lines, with 16 issued patents and 91 pending applications spanning 15 patent families, as well as eight more pending applications across four other patent families related specifically to skin care products. International Stem Cell Corporation has even licensed an additional portfolio of 11 issued and 14 pending patents/applications covering eight patent families in order to further secure its broad-spectrum and rapidly developing hpSC treatment pipeline.

This pipeline includes developing the same hpNSCs used to treat PD, in order to provide stroke patients with the first real solution to this leading cause of adult disability, and the company already has robust preclinical evidence that injection of these highly-pure hpNSCs can be used to actually reverse functional deficits when applied even several weeks after the initial event. This one development would be a major commercial victory for the company and it would also largely establish the concrete viability of its parthenogenetic technology for creating commercial-scale, implant-ready cell banks for the ischemic (roughly 87 percent of cases) stroke treatment and other markets. Not to mention being a game-changer for the roughly 691,650 people every year in the U.S. who suffer from ischemic strokes. People whose only current option is costly, laborious, logistically difficult to implement, and often ineffective cognitive/functional rehabilitation. Commercial success in either PD or ischemic stroke would roundly validate the company’s underlying therapeutic approach for treating other diseases and disorders as well, potentially opening a floodgate for the company and allowing them the kind of financial muscle and industry clout needed to knock down additional targets with hpSC-based therapies.

The company’s hpSC technology is currently being developed for areas such as age-related macular degeneration via parthenogenetically-derived human retinal epithelium (RPE) cell therapy, as well as for corneal blindness and many other eye diseases/disorders via the production of corneal cells and whole corneal tissue. This same technology also shows great promise for treating metabolic (and other types of) liver diseases, such as Crigler-Najjar syndrome (inherited), and the company has already successfully created and characterized stem cell-derived liver cells under its CytoHep program, whose transplantation has been shown to effectively delimit the brain and nerve damage associated with Crigler-Najjar syndrome in preclinical animal models.

If one observes all of these emerging hpSC treatment vectors from a wide angle, it becomes strikingly apparent that we could potentially be treating a whole host of degenerative and other diseases/disorders with 100 percent ethically derived stem cell technology. International Stem Cell Corporation is at the forefront of this industry and the shoring-up of its share structure in anticipation of up-listing to a major exchange, in conjunction with the upcoming landmark clinical trials in PD, for which the company has already comfortably sustained the cost on and manufactured a cell bank of over 2.6 billion high-purity hpNSCs (enough to satisfy all foreseeable clinical trial needs), is an extremely bullish indicator to the investment community about where the company is heading.

Continued success of the company’s already commercialized cosmeceutical and biomedical product operations forms a key backdrop for International Stem Cell Corporation when it comes to funding ongoing clinical and preclinical efforts, further differentiating the company (alongside its strong IP position) from competitors.

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Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.