There are two biotechnology companies that have grown legs to stand on in the past few years. They are Geron (Nasdaq: GERN) and Advanced Cell Technology (ACTC.OB). Both share the accomplishment of receiving approval from the U.S. Food and Drug Administration for their efforts. That's an accomplishment exclusive to them in an industry that has battled everything from federal funding removal and subsequent reinstatement, to political figures (including a U.S. President), Christian conservatives and moral groups who have worked to derail their work. Each has also weathered the losses of their CEO’s. For ACT, the loss was of a respected and driving CEO William Caldwell to an untimely death; for Geron it was the untimely resignation of Thomas Okarma, its long-time employee and CEO.
Geron and Advanced Cell Technology have nonetheless kept focus and worked diligently to develop their respective therapies based on regenerative medicine. The benefits of their efforts may be about to be realized as investors are taking note. The reasons for the raised eyebrow reactions are upcoming clinical trials and Patent approval of their Intellectual Property (IP).
Advanced Cell Technology in particular has been in the limelight recently for its efforts. Wednesday, the Marlborough, MA-based firm announced that it has received patent approval (Patent Number 7,893,315) for its proprietary single-blastomere technology that provides a non-destructive alternative for deriving human embryonic stem cell (hESC) lines. The significance of this IP cannot be overstated for the firm whose stock has climbed from a basement level of .04 per share in November to a current day level of .18, and which has held that level for the past few months. It is almost unbelievable that this small cap firm is still priced at that level considering its position in the biotechnology and regenerative medicine field, its recent FDA approvals and now its IP accomplishment which represents a validation of its “safe embryo’s” technique, therefore addressing most criticism of the company's work.)
On Nov. 22, 2010, ACT became the second company to win permission from the U.S. Food and Drug Administration to conduct a trial of human embryonic stem cells. In that case, to treat Stargardt macular dystrophy, a rare form of macular degeneration that strikes children.
The first company, Geron Corp. of Menlo Park, California, said on October 11, 2010 that it used embryonic stem cells to treat the first of 10 patients with spinal-cord injuries.
In October of 2010, Geron announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of the study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the Phase One study must be newly injured and receive GRNOPC1 within 14 days of the injury.
The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, GA. Shepherd Center is one of seven potential sites in the United States that may enroll future patients in the clinical trial.
ACT is pursuing several trials. One is to address Stargardt's Disease. The sites which are currently under consideration are the Jules Stein Eye Institute at UCLA, the Casey Eye Institute in Portland, Oregon , the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts, and the [New Jersey Medical School] University of Medicine and Dentistry of New Jersey in Newark. Additional sites may be considered.
ACT is also planning a Dry AMD clinical trial. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.
ACTC has a market cap of roughly 228.42M. It’s 52-week range has swung from a low of .04 to 0.27.
Geron Corporation, has a market cap of nearly 494.M, and a 52-week range: of 4.37 - 6.44.