Radioisotopes: New Hope Using An Old Therapy

by: Chemistfrog

Savvy investors in the pharmaceutical sector often spend a great deal of time researching the latest and most promising trial data and try to ascertain before the masses what the "next big thing" will be in disease treatment. Early entry into volatile and small cap pharma is desirable for traders more willing to tolerate high risk. Others prefer the safer, but often correspondingly lower returns via entries in the large pharmaceuticals with higher market capitalizations and stable revenue, but even these companies can provide for nice returns as patient and well-educated investors may take advantage of dips in stock prices and then hold for the longer term.

When viewing headlines in the pharma sector for 2012, readers see advances in treating diseases through stem cell therapy, immunotherapy, antibody drug conjugates and a host of other modern marvels that the healthcare sector could only dream of just a couple of short decades ago. However, improvement in harnessing the power of tried and true radioisotopes for treating cancers is showing a great deal of promise. Novel methods used to target tumors and reduce unwanted radiation exposure to patients, healthcare providers and even loved ones grow more advanced by the day. While not grabbing many headlines from the mainstream and higher profile therapies aforementioned as of yet, there are companies that may benefit investors in the near future as their trials and technologies advance and may soon begin sharing the spotlight.

Following is a diversified group of pharmaceutical companies with promising therapies addressing novel improvements in radioisotope treatment of cancer. There appears to only be marginal coverage and awareness of some of these companies, while others are mainstream, but their radiotherapy treatments are overshadowed by other "sexier" therapies in their pipelines.

AREVA Med (OTCPK:ARVCF) and Roche Holdings (OTCQX:RHHBY) are two established companies that have recently joined forces to develop a novel radioimmunotherapy platform for fighting cancer. On July 27th they announced their collaboration will "combine Roche's expertise in engineered antibodies with AREVA Med's proficiency in developing radioactive isotopes." This partnership, combining two solid companies with a global presence in the pharmaceutical world, will likely bring new attention to radioisotope use in cancer treatment as it will be utilizing the Lead-212 radionuclide paired with highly specific antibodies to target and irradiate cancer cells while reducing systemic exposure throughout the patient's body and even closely-located healthcare providers and family members.

AREVA has already initiated a phase I trial using Lead-212 and a monoclonal antibody. The treatment is called Pb-TCMC-Trastuzumab, and the trial was initiated in July 2011 to treat intra-abdominal HER-2 expressed cancers. The trial is scheduled to run for two years, so the company is now at the half-way point in its duration. No updates have been posted on interim data, but a press release on May 3rd announced an additional enrollment site. Lead-212 is a promising and unique isotope as it is a short range isotope with the dissipation of energy at an energy level minimizing exposure to surrounding tissue already. Utilized in a targeted radioimmunotherapy setting further reduces systemic exposure and should offer a much-improved safety profile over conventional radiotherapy treatments. Attention to the AREVA Med trial should increase in the coming months as the trial nears completion in addition to the new attention AREVA's and Roche's collaboration will likely bring to both companies and radiotherapy.

Advanced Medical Isotopes Corporation (OTCPK:ADMD), also known as AMIC, made headlines in April of this year by obtaining exclusive rights to eight patents encompassing injectable radiogel for high-dose interstitial radiation therapy from Battelle. Like AREVA's technology, radiogel also works to reduce systemic exposure. However, the radiogel technology is likely a much lower cost treatment as it utilizes an injectable water-based polymer gel that delivers Yttrium-90 microspheres directly to the tumor tissue either transdermally or intraoperatively. Once inside the body and warming to the body's temperature, the gel polymerizes into a lattice that traps the radioactive Y-90 microspheres allowing irradiation of the surrounding tissue while not allowing the radiation to travel throughout the body.

Y-90 is a commonly-used isotope with a half-life of about 64 hours, so it degrades quickly after it performs its initial irradiation. Although details on the company's plans for the technology haven't yet been revealed, AMIC's Chief Scientific Officer, Dr. Robert Schenter, noted in the press release that "AMIC continues to develop the Yttrium-90 radiogel line with Pacific Northwest National Laboratory, operated by Battelle. We believe that this product optimizes treatment of radiation-resistant tumors in vivo. We expect the radiogel to become a therapeutic agent that provides physicians with the ability to effectively treat tumors that cannot be removed surgically or that cannot be treated by any other means." Investors should watch for updates on this collaboration and make investment determinations as events unfold.

With many other radioisotope products available on the company's website, manufacturing or supply partnerships along with any updates from the radiogel collaboration may be nice share price drivers for this budding company with an $20.6 million market cap as of market close on Tuesday the 31st. Currently operating at a loss, a recent stock offering should shore up the company's cash position at least for the interim and reduces the need for dilutive offerings at least in the near future.

Spectrum Pharmaceuticals (NASDAQ:SPPI) is having a phenomenal year with earnings growing at a huge pace largely in part due to colon cancer drug - Fusilev - sales. With $22.3 million in April and another $24.8 million in May, 2Q sales could reach $90 million according to estimates. Spectrum's other approved therapy, ZEVALIN (administered as a combination of Rituxan and Y-90 ZEVALIN), should be of interest to shareholders looking for radioisotope investment exposure. A labeling change in November of 2011 removed the requirement that patients undergo an "imaging dose" of ZEVALIN along with Rituxan and a subsequent imaging scan a couple of days later to observe how the drug is being distributed in their bodies. It wouldn't be until a week or two later when the patients would undergo therapeutic doses of ZEVALIN along with Rituxan. The labeling change removed the preliminary "imaging dose" and subsequent scan and is thought to benefit sales with the simplified and likely less expensive regimen.

More importantly, when fighting aggressive cancers, a "week or two" wait before beginning therapeutic treatment after simple imaging analyses may make a huge difference in prognosis for some patients. Like AMIC's newly-acquired radiogel technology, ZEVALIN also utilizes Y-90 with impressive trial data backing up its efficacy. An earlier labeling change for ZEVALIN in 2009 to include patients with previously untreated follicular non-Hodgkin's Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy noted phase III data stating "at 3.5 years of follow-up, the FIT trial demonstrated that when used as part of first-line chemotherapy for patients with follicular NHL, ZEVALIN significantly improved the median progression-free survival time from 18 months (control arm) to 38 months (ZEVALIN arm) (p<0.0001)" ... a very strong statistical correlation. ZEVALIN is also in trials for Diffuse Large B-Cell Lymphoma and with MGd in Rituximab-Refractory Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma with impressive interim data. With an exciting pipeline and a host of catalysts from trial data ahead of them, Spectrum is a solid investment for those seeking exposure to modern radioisotope therapy in treating cancer with much upside still possible for this $914 million market cap pharmaceutical company.

Presented are exciting companies that may make good investments for those wishing to expand their portfolio exposure to include novel new advancements in radiotherapy for treating cancer. Each of these companies has something different to offer with a wide range of indications possible, diverse market capitalizations and varying company financial situations.

RHHBY and ARVCF are pharmaceutical entities with a global presence and represent a wide range of already-marketed products. SPPI's financials are improving almost daily as Fusilev and ZEVALIN sales continue to improve with awareness and expanding indications. ADMD is a development-phase company that is still operating at a loss but is beginning to diversify its business model beyond its product line of radioisotopes to include a clinical candidate that it may develop on its own, partner out to another, outright sell or use to tempt a pharmaceutical suitor. As modern radiotherapy continues to advance and start generating additional attention, any or all of the presented companies may benefit from or contribute to the new hope that is coming for cancer suffers needing novel, new radiotherapy treatments to fight cancer.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in OTCPK:ADMD over the next 72 hours.