Companies Positioned for Treating Acute Radiation Syndrome

Includes: CBLI, CLBS, OSIR
by: John Eastman

The world has watched with great concern the news and information surrounding the largest recorded earthquake (magnitude 9.0 ) in Japanese history. As reported, the quake was the underlying factor in major tsunamis that ravaged the northern Japan coastlines and damaged three nuclear reactor facilities. The Fukushima Daiichi nuclear power plant, 240 km (150 miles) north of Tokyo, suffered the greatest damage and by some reports is still leaking radiation into surrounding areas of the air and water. It is possible that the impacted sites will be not inhabitable by life forms for thousands of years.

Approximately 200,000 people have been evacuated from around the plant, some injured from radiation burns, others developing radiation sickness from poisoning quickly thereafter. Potentially a great number of people could be sickened or their death caused by Acute Radiation Syndrome (ARS). This is especially apparent in the event of a nuclear plant explosion.

In instances where individuals have moderate to high levels of radiation exposure there may not be hope for survival. Many victims will have received enough radiation to injure but not kill their bone marrow. They can possibly recover from their initial injuries but are impacted by the reality of a 30–60 day period during which they cannot fight infections. During this stage, they are prone to uncontrolled bleeding and anemia. Their immediate need is to receive supportive care until their hematopoietic system recovers. This is a challenge as environmental factors and the nature of the disaster itself poses treatment issues. Potassium Iodide may be used for the prevention of thyroid cancer from radioactive iodine, and antimicrobials may be used to prevent infection due to the degradation of the immune system. In past nuclear disaster situations, such as in Chernobyl, such care was not possible in the field.

The human hematopoietic (blood-forming) system is especially susceptible to radiation injury. As a result of radiation injury to the blood forming system, victims suffer from a lack of the cells that deliver oxygen (red blood cells), cells that detect and eliminate infectious agents (white blood cells), and cell components that promote blood clot formation (platelets). This set of symptoms is generally referred to as Acute Radiation Syndrome (ARS) which is both dose and time dependent in the sub-syndromes and complications that can occur.

Minimal treatments are available to help people with radiation poisoning but this landscape is changing due to biotech companies that are developing solutions. There are multiple approaches to therapy and treatments, and as research progresses, more possibilities are underway.

The U.S. government has been investing in treatment options to assist in the development of anti-radiation treatments. The Biomedical Advanced Research and Development Authority (BARDA), NIH (National Institute of Health, and Department of Defense (DoD) have all played key roles to the tune nearly $500 million (U.S.).

A possible treatment for the loss of white blood cell production is the use of the growth factor Neupogen to boost their numbers. A quite unique approach is stem cell transplantation.

If the transplant is performed within 7-10 days of exposure, cure rates can be high for this procedure. Stem cell transplantation has been used successfully in Japan following the Tokaimura nuclear reactor accident in 1999. Stem cell transplantation has improved since then with the advent of autologous engraftments. In the past, therapies required donation of stem cells from family or close relatives to assure a close match. In many instances, grafts were rejected. Autologous transplants take stem cells from the patient, ensuring a perfect match. This procedure only works if you have cells of your own to work with. In cases of severe ARS, patients may have much of their stem cells destroyed.

As there are multiple therapy tracts, some initiated before, during or after radiation poisoning, others more on the preemptive side. There are various biotech firms posing solutions:

NeoStem Inc. (NBS) has a unique approach in that they prepare for use in the future by individuals their stem cells until they are needed. Its core business is the collection and storage of stem cells for those who want such an insurance plan. NeoStem has facilities across the U.S. to collect the cells, and its recent acquisition of Progenitor Cell Therapy has further enlarged its business, giving it additional scale. The company is conducting additional research on what are termed Very Small Embryonic Like (VSEL) stem cells that may have the potential to be used in bone marrow rescue through an autologous stem cell transplant. With the spotlight on potential nuclear disasters, NeoStem’s multi-solution approach and business plan for stem cell transplantation - accompanied with housing of individuals cells - positions them in a very positive way, one that the investment community may take note of in the current times. Currently trading at 1.83, their 52wk Range is 1.10 - 3.50 and a Market CAP of 105.43M.

Osiris Therapeutics (NASDAQ:OSIR) has a product which is currently being developed, called Prochymal. It is currently in FDA Phase III clinical trials for two diseases with clinical manifestations similar to acute radiation syndrome (ARS). These indications have Fast Track status by the FDA. Prochymal therapy could be administered post exposure or at the onset of symptoms, eliminating the need for a predefined treatment. Osiris' stem cells are derived from human bone marrow. The long-term storage capability of Prochymal makes stockpiling for a mass-health event feasible. Currently (4.11.11) trading at 6.72 on Volume of 49,870, it is on the lower end of the spectrum of a 52-week range of 5.39 - 8.58, on the Its market CAP is 220.54M.

Cleveland BioLabs (NASDAQ:CBLI) has based its focus on molecular mechanisms by which radiation induces cell death to develop pharmaceuticals that address this need. The firm’s Protectan compounds reportedly rescues mammals from lethal doses of radiation by suppressing apoptotic cell death in critical hematopoietic (HP) and/or gastrointestinal (GI) tract cells. The company is currently developing derivatives of microbial factors that are natural regulators of apoptosis as Protectans, molecules that prevent death of normal cells in the face of stresses such as radiation. The lead Protectan compounds CBLB502 and CBLB600 series have significant activity as both radioprotectants (injected prior to radiation exposure) and mitigators of radiation damage (injected after radiation exposure). The underlying principle of radioprotection by Protectans, and their structures and uses, represent the intellectual property of CBLI developed in collaboration with the Cleveland Clinic.

Cleveland BioLabs is currently trading at 7.92, at the high end of a 52-week range of 2.80 - 9.60. Its market cap is 230.65M. With a strong focus on a Department of Defense tract, the company may be well positioned for growth.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.