International Stem Cell Corp., a biotechnology company, is focusing on developing novel stem cell-based therapies and biomedical products. The company recently declared its first quarter results; reporting year-over-year revenue growth of 28% to $1.65 million, with a gross margin of 73%. The revenue was mainly driven by the strong performance of its subsidiary, Lifeline Cell Technology, which contributed around 51% to the company’s total revenue.
On April 29, after six month of its trial study, the company reported significant behavioral improvement in its pre-clinical non-human primate (NHP) study of PD. The company spent around $958,000 on research and development (R&D) in the last quarter compared to $721,000 in same period last year. The increase in R&D was mainly driven by the increased stem cell line research and testing expenses. This helped the company to improve the efficacy of its drug to treat PD, which is based on its stem cell line technology.
Superior results from the pre-clinical study for treating PD
International Stem Cell, after six months observation of its pre-clinical non-human primate (NHP) study for PD, reported significant behavioral improvement in the PD cases. The company divided the total primates that have matching levels of Parkinsonism and functional disability into three groups. Out of these three groups, two received different doses of human neural stem cells (hPNSC) developed from ISCO’s proprietary parthenogenetic stem cell line “phSC-Hhom-4.” The company in initial experiments on mice demonstrated that the neuronal cells derived from this technology lived in mice brain without developing tumors. This shows that the company’s stem cell line technology has higher potential to provide improved graft acceptance and possible therapeutic applications, including treating PD.
International Stem Cell’s technology helped it to demonstrate healthy behavior scores (the intelligence quotient level of the individual) of the treated group, which were increased by 170% compared to just 58% in placebo group. The third group demonstrated a significant improvement in the main Parkinson’s rating score of 63% (p< 0.05) compared to minute improvement in the control group.
This significant change in the scores signifies a greater reduction in the severity of the symptoms in the treatment group compared with the control group. This is expected to lead to higher improvements in International Stem Cell’s trial studies. Further, as per the meeting with the FDA in February, the company plans to complete FDA-required pharmacology and safety studies by the end of 2014. The recommendations on the PD trial program from the FDA will allow the company to improve the efficacy of the drug. This could reduce the risk of the any delays and integrating the recommendation from the FDA in the program will enable the company to develop stronger Investigational New Drug (IND) applications with a greater chance of positive reviews.
Market opportunity in PD treatment
PD is the 14th leading cause of death in the U.S. Also notable, The Parkinson’s Disease Foundation estimates around seven million to ten million people are living with PD globally and around one million are in the U.S. alone. Further, around 60,000 new cases of PD are diagnosed annually in the U.S., and the total direct and indirect cost of PD is estimated to be around $25 billion per year. Medication costs for an individual suffering with PD is around $2,500 per year, and therapeutic surgery can cost $100,000 per patient.
The superior results demonstrated by International Stem Cell in the pre-clinical trial of its PD program and its efforts to improve the efficacy of its drug will enable the company to take advantage of the underlying opportunities in this PD medication market.
Conclusion
International Stem Cell with its “parthenogenetic stem cell line” technology will be able to improve the efficacy of its new drug candidates for treating PD. Further, fulfilling the FDA norm and integrating the FDA recommendation in its PD program will help to avoid the delays in submitting the IND application to FDA. The success of the PD program will generate greater opportunity in the PD medication market, which will in turn strengthen its long-term financial position.
For more information, visit www.internationalstemcell.com
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