96% of Patients Experience NO Recurrence of Brain Cancer After IsoRay Treatment

IsoRay, Inc. (ISR – $1.76), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of cancers of the prostate, brain, lung, head and neck and gynecological, announced exceptional results conducted by researchers at the Barrow Neurological Institute, one of the world’s foremost brain cancer research and treatment sites.

The Barrow study reported on 27 patients who had a variety of deadly brain cancers. The patients had received as many as four earlier treatments that had failed, resulting in a recurrence of their cancers in the same locations that previously had been treated.

This time, oncologists employed a different technique on these patients. Following surgical removal of the tumor tissue, Cesium-131 was delivered to the targeted brain tissue using a modular, pre-commercial biocompatible carrier system that provided custom-tailored implants for each patient.

The patients fared better than they had using earlier, conventional treatment. In fact, 26 of the 27 patients (96%) have not experienced a recurrence of the treated cancer within the treated bed during the follow-up period.

IsoRay CEO Dwight Babcock commented, “We are extremely excited to see that Cesium-131 isotope seeds continue to perform so well against aggressive cancers throughout the body, including a variety of brain cancers as shown in this study. This further confirms other peer–reviewed results showing Cesium-131 can have a very favorable impact on local control, especially for cancers that have shown a tendency to recur at the site of surgery.”

IsoRay’s stock price climbed from $1.62 to $1.84, up 13 percent on the new, and even reach an intraday high of $2.18. Over 9 million shares exchanged hands, about 9 times the average volume.

IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).

Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body.

Successful Treatment of Young Peruvian Girl

IsoRay’s Cesium-131 treatment continues to cure patients worldwide. Next to the outstanding study results mentioned above, another remarkable story is the one of a seven year old Peruvian girl who was diagnosed with a potentially life-threatening brain cancer in March of 2014. The 2.7 cm tumor was located very close to the brainstem, making surgical removal too risky to attempt.

Because of the increasing pressure on the brain produced by the tumor, the young patient was experiencing significant weakness, trouble maintaining alertness and even walking. External whole brain radiation therapy and chemotherapy resulted in no improvement to the patient’s worsening condition.

After working with IsoRay’s Richland, Washington, U.S. based team, a custom Cesium-131 implant was designed and manufactured for placement directly into the tumor in the patient’s brain. Care was taken to devise an aggressive implant that could deliver a high dose of cancer-killing radiation to the cancer while sparing the very closely associated brain and brainstem structures.

In July 2014, a Cesium-131 seed was implanted directly into the brain tumor of the girl. The patient’s recovery was remarkable as she was alert and eating the next day. She recovered from the implant without incident.

After a couple of weeks she was again able to walk without assistance. As of September 2014, ten weeks after the implant, with over 99% of the radiation from the implant delivered, an MRI scan showed a 70% reduction in the mass of the tumor. This young girl has now returned to school without assistance or special accommodations and also returned to her normal activities.

First Quarter Results

During the first quarter, ended September 30, 2014, IsoRay reached revenues of $1.04 million, about even compared with the first quarter in 2013. Prostate brachytherapy sales accounted for approximately 88% of total revenues. The operating loss declined about 6% from $1.23 million in the first quarter of 2013 to $1.16 million in the comparable period this year.

At the end of the quarter, the company had more that $22 million in cash, short-term investments, and CDs.

Sales in the prostate treatment arena are doing quite well. In fact, brachytherapy utilizing Cesium-131 has since been used by over 8,300 men as their isotope of choice for treating prostate cancer. Three recent studies detailed a total of 412 patients treated with Cesium-131 brachytherapy as their sole treatment for localized prostate cancer. As a group, these patients are experiencing a 96% freedom from Prostate-Specific Antigen (PSA) progression rate between five and six years.

On the other hand, it’s clear that IsoRay needs to step up its marketing efforts to inform the medical community about its Cesium-131 products to treat other cancers. For that exact reason, IsoRay recently hired additional sales representatives, who are strategically located throughout the U.S.

Those additional marketing initiatives are already bearing fruit as several outstanding medical centers have started using Cesium-131 during the last quarter. Some notable names now utilizing Cesium-131 in treating tumors in various body sites include Massachusetts General Hospital, Johns Hopkins, Harvard affiliate Brigham and Women’s, Rutgers Medical School and MD Anderson.

Conclusion

IsoRay’s various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite(R) radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay’s cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.

The Company is actively bringing new brachytherapy applications to the market, providing new solutions to leading physicians throughout the world. The Company’s continued investment in research and development focusing on Cesium-131’s efficacy for treatment of various cancers located throughout the body is expected to have a direct impact on its overall growth with an expanding array of non-prostate cancer treatments.

In addition, the recent reorganization and increase in the size and quality of IsoRay’s sales organization in the US market has created the means to contact more facilities than ever before with the Company’s new and novel treatment alternatives.

All in all, the company’s stock price didn’t react that much to the outstanding results of the brain cancer study, as it only appreciated 8% during the week. While that’s a bit of a disappointment, we’re very pleased with the stock’s performance in 2014 as it gained 135% since we first recommended it in February. In addition, the results again confirm the wonderful potential of Cesium-131 and… IsoRay.

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