Radiotherapy has been used to fight cancers for over 100 years. There are basically two means to administer radiation: external radiotherapy and internal radiotherapy (also known as brachytherapy.) With internal radiotherapy a radiation source is administered with precise placement inside or next to the site of the cancerous tumor. It is commonly used as an effective treatment for prostate, breast, cervical, and head and neck cancer, as well as others. The radioactive material, or seeds, inserted in the body cavity are generally delivered via a catheter allowing for a higher dose of radiation to a more specific part of the body. It differs from conventional radiation therapy, which uses an external beam, that projects radiation from outside of the body; thus brachytherapy has shown to cause fewer side effects and requires a shorter treatment time than conventional radiation. However, there are limitations to conventional brachytherapy, the most prominent being the need to surgically implant and remove the seeds (in some cases). But brachytherapy is also advancing in its delivery systems, and new methods are being tested to develop the next generation of this type of radiotherapy.
A new method tested at Duke University uses an alternative brachytherapy approach by injecting the seed directly into the body instead of using a catheter to deliver the radioactive material. The doctors, using mice models, injected the tumors with a biodegradable elastin-like polypeptide (ELP) with radioactive iodine, which they found shrank the tumors, and in some cases eliminated the tumors completely. The researchers identified the ELP that had demonstrated the best tumor retention, and they tested three variations (in mouse models) of prostate and head and neck cancers. After only a single administration, the most effective variation shrank tumors in all of the mice regardless of tumor type. It also completely eliminated tumors in two-thirds of the mice with head and neck tumors, and all of the mice with prostate tumors. Dr. Wenge Liu, associate research professor of biomedical engineering at Duke University, and lead investigator of the study explained, "We set out to develop an alternative approach to brachytherapy that would eliminate the need for surgery." Dr. Liu continued, "We believe that this approach provides a useful alternative to existing brachytherapy, which requires a complicated surgical procedure to implant the radioactive seeds. Moreover, these injectable seeds degrade after the radiation is exhausted, so they do not need to be surgically removed." Thus injectable treatments could eliminate some of the difficulties associated with brachytherapy, and in the future this injection method could be used as a treatment for a variety of cancers, replacing conventional brachytherapy.
Interestingly, a small isotope company from Kennewick, Washington, Advanced Medical Isotope Corporation (OTCQB:ADMD), has been touting its Radiogel cancer treatment, an injectable therapy similar to the one discussed above, though using a different isotope. The therapy is a radiotherapy treatment where a water-based polymer containing yttrium-90 microspheres (Y-90), a medical isotope used to fight cancers, is injected directly into the tumor. Once injected, the body's own heat causes the liquid to turn into a gel forming a lattice around the Y-90 microspheres in the targeted area. The high-energy beta particles irradiate cancer cells in the target mass with little of the radiation affecting nearby healthy tissue. This maximizes the radiation dose at the tumor while minimizing exposure to nearby healthy tissues. Radiogel therapy can be delivered either during a surgical procedure or with an injection directly through the skin into the solid tumors and can be used when a cancer tumor cannot be surgically removed. ADMD acquired the license and numerous patents relating to Radiogel from Battelle, the world's largest independent research and development company. Radiogel technology could have a major impact on the future methods used to battle various cancers. The positive news from the research at Duke University could serve to validate Radiogel's use and additionally provide for more exposure for ADMD.
Interestingly, ADMD started as an isotope production company and is becoming one of the few companies producing medical isotopes in the USA. In May of 2010, the company entered into a licensing agreement for the patent rights in the area of radioisotope production using electron beam accelerator(s) for creating short-lived radioisotopes such as Mo-99 and Tech-99 with the University of Missouri. ADMD is also producing short-lived and stable isotopes for Positron Emission Tomography (PET) procedures with a PULSAR Isotope Production system, the first compact linear accelerator (LINAC) in North America designed for the production of medical isotopes used in PET imaging. Medical isotopes are big business; the demand is on the rise. In the USA, 18 million medical procedures use medical isotopes, and the demand is expected to rise 10% annually. 90% of all the non-PET radioisotopes used in the United States are imported giving ADMD quite a future in isotope production and sales.
ADMD is an $18 million market cap company, selling for just under $0.25 per share, which could be considered a bargain basement price if either its Radiogel proves successful or its isotope line proves lucrative. Either way, ADMD now has two separate avenues to develop product raising its odds of becoming a successful company. I like ADMD, I see a lot of potential growth with both its medical isotope production and its move into the nuclear medicine with Radiogel, and if successful I wouldn't be surprised if a larger pharmaceutical company swoops in to buy up ADMD. Considered to be a speculative buy until the company begins to prove itself more, interested investors should consider all risks associated with this mostly development-phase company including its OTC status, its financials and its small $18 million market capitalization.
Injectable may or may not be the future in brachytherapy, but today's treatments still require surgical methods to implant the seeds, and Theragenics Corporation, (TGX) a micro-cap company based in Buford, Georgia, may have one of the better treatments on the market with its TheraSeed, a brachytherapy to fight prostate cancer. Prostate cancer is the most frequently diagnosed cancer, and the leading cause of cancer deaths in men. The American Cancer Society estimates there will be 241,740 new cases of prostate cancer diagnosed this year, and an estimated 28,170 will die in the USA due to the disease. Theragenics has treated over 150,000 prostate cancer patients over the last 25 years. The treatment utilizes between 50 to 150 seeds consisting of biocompatible titanium that encapsulates the radioactive isotope, palladium-103 (Pd-103), which is implanted throughout the prostate using transrectal ultrasound to guide the process. The half-life of Pd-103 is 17 days, resulting in the loss of virtually all radioactivity in less than six months. Theragenics, through its purchase of Core Oncology earlier this year, also carries an iodine seed device, I-Seed, that utilizes the radioactive isotope iodine-125 (I-125), with a half-life of approximately 60 days and a loss of almost all radioactivity in approximately 20 months. Both TheraSeed and I-Seed together should help increase the company's revenue in this unique niche market.
Theragenics is a $43.7 million market cap company, and though solid, its stock is down over 13% YTD and has been flat the past 5 trading sessions where it sits at $1.47 per share in light volume. Last month the company announced its 3rd quarter earnings of $19.9 million, down 5% from the previous year. Earnings per share were $0.02 compared to $0.03 the previous year. Healthcare companies are dealing with the uncertainty of health care reform and a weak economy, which could account, in part, for its lackluster performance. However, Theragenics has established itself over the years as a quality company. In July the company completed a $10 million stock repurchase with cash on hand. Even though the stock has done little since its pre-recession highs, I do like this stock and I can see its product line growing. However, caution and due diligence is advised when investing in any micro-cap company as there can be wild swings, as seen when the stock climbed to $2.10 per share in July, only to drift back downward. But I think the worst is behind it and, as earnings increase, I look for the stock to move upward.
Varian Medical Systems Inc. (VAR), based in Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. Earlier this month it announced that it has received regulatory clearance from the Indian Atomic Energy Regulatory Board for the use of its popular TrueBeam High Intensity Mode for advanced radiosurgical treatments. TrueBeam is designed to treat lung, breast, head and neck, and other cancers that are often treated with radiotherapy. The system uses sophisticated imaging and respiration synchronization tools to visualize soft tissue during treatment and make adjustments accordingly. With new beam-shaping capabilities used with the High-Intensity Mode, it enables the delivery of large doses in small targets. TrueBeam treatment can be delivered with sub-millimeter accuracy and varying intensity. The idea is to deliver the lowest dose possible to the surrounding healthy tissue, while still delivering the maximum dose to the tumor. The reason this is big news for the company and investors is that India's population is over one billion. And since the population has adopted a more of a western lifestyle, breast cancer has been dramatically on the rise: 100 thousand new cases of breast cancer are reported per year, and it is estimated by 2015 that number will rise to 250 thousand cases per year. Varian has placed a sizeable number of linear accelerators in the country and holds a notable position in the market.
Varian has a market cap of $7.8 billion with a P/E ratio of 18.44, and offers no dividend. The company announced its quarterly earnings on October 25th, of $1.08 per share beating the analysts' consensus estimate of $1.03 by $0.05. Also its quarterly revenue jumped 5.1% on a year-over-year basis. Analysts at Cantor Fitzgerald, which currently have a hold rating on the stock, raised its target price from $63.00 to $70.00 in a research report sent to investors. However, analysts at SunTrust initiated coverage on Varian on November 16th, setting a buy rating with an $81.00 price target. Benchmark Co. also set a buy rating on November 16th with an $88.00 price target, while analysts at Zacks reiterated a neutral rating with a $70.00 price target. I like Varian; it has a strong balance sheet, low debt, and a decent amount of cash, which it has been known to use to repurchase its own stock. The caveat in the deck stems from the uncertainty of the effects of the health care reform and weak economy in developed countries, especially those in Europe. However, I see Varian as a good company with a strong business model and solid pipeline of products, and it appears to be a good value stock to have in one's portfolio.
Radiotherapy is evolving with new devices and therapies. Companies like Varian and Theragenics have a track record of successful devices on the market. Upstart ADMD, on the other hand, is taking a different approach to brachytherapy using an injectable, as opposed to a surgical, procedure in treating cancers. And judging by the success of the Duke University study, the injection method works. That is why I think ADMD, with its Radiogel, has the best chance of the three for its stock to rise significantly. However, until either of its products proves to be successful, ADMD is a speculative investment and there are risks. Radiogel is in its early stages and will require regulatory approval, so caution and due diligence is advised when investing in small companies.