The most common cancer treatment today is surgical intervention. According to the American Cancer Society, "Most people with cancer will have some type of surgery." However, there are certain situations in which surgery is not a viable option because of factors like the spread of the disease, tumor location and the health of the patient. When surgery has been ruled out, the traditional alternative treatments of radiation therapy and chemotherapy are often used. These methods are also used to destroy the cancer cells that remain around the surgical site or have spread to other parts of the body through the bloodstream or the lymph nodes. Unfortunately, these treatments also have unpleasant side-effects, and since the cancer tissue cannot be solely targeted, healthy tissue is often damaged. Several companies are developing new minimally invasive or non-invasive treatments to treat such non-resectional cancers. I have found three that I consider to be investment grade and offer them up to potential investors for consideration.
OncoSec Medical Focusing On Electroporation via ImmunoPulse and NeoPulse
The first promising platform of minimally-invasive treatment I wish to present is called electroporation, in which electrodes are used to apply an electric current across the tumor or a specific area of cancer tissue, which has been injected with an anti-cancer agent. The current induces a significant increase in the porosity of the target tissue, and allows a much larger uptake (up to 4,000 times higher) of the anti-cancer agent. Once the current is removed, the tumor cell membranes reseal and trap much of the agent inside, thus increasing the efficacy of the treatment. The targeted approach means that lower doses of the anti-cancer agents are required, which minimizes harmful side-effects and spares more healthy tissue.
OncoSec Medical (OTCQB:ONCS) is developing a proprietary electroporation platform called OMS, which is a drug-delivery system for approved anti-cancer agents. The company has developed two separate treatments, ImmunoPulse (formerly ElectroImmunotherapy) and NeoPulse (formerly ElectroChemotherapy). NeoPulse delivers a proven and approved chemotherapy agent directly to the site affected by cancer. Although the treatment has the potential to be used with a number of different chemotherapy agents, the company is concentrating on bleomycin, which has already been approved for use in several different types of cancer.
OncoSec Medical acquired the technology as well as the clinical trial data from Inovio Pharmaceuticals (INO). Inovio carried out phase III trials for head and neck cancer, but enrollment was terminated in 2007 after the Data Monitoring Committee (DMC) recommended trial termination because of concerns about efficacy and safety. OncoSec presented re-evaluated data in July of 2012, and has confirmed that there are no safety problems. This will be validated when additional trial data is gathered and analyzed.
ImmunoPulse takes a much different approach from traditional cancer treatments. It makes use of the body's own immune system to attack cancer cells. An IL-12 plasmid DNA construct is introduced directly into cancer cells via electroporation. This DNA construct instructs the cells to produce interleukin-12, a naturally occurring protein that stimulates cytotoxic T-cells and macrophages to attack and destroy the cancer cells, which they would normally ignore because the cancer cells are not typically recognized as dangerous by the body's immune system.
In an earlier phase I melanoma study involving 24 patients in the U.S., preliminary results showed that the treatment was both safe and effective. The study also showed that there were no increased levels of IL-12 or interferon-gamma in blood serum, which means that there are no toxicity issues. The IL-12 produced was largely confined to the electroporated cells themselves thereby having efficacy and maintaining the therapy's safety profile. OncoSec has begun three phase II trials for late-stage metastatic melanoma, Merkel cell carcinoma (MCC) and cutaneous T-cell lymphoma (CTCL). MCC and CTCL are uncommon forms of skin cancer, and CTCL is very aggressive and lethal in the late stage. MCC is three times more deadly than melanoma.
According to OncoSec Medical, DNA IL-12 and electroporation are comparable to, or exceed, response rates of other approaches to melanoma, including Bristol-Myers Squibb's (BMY) Yervoy and Genentech's Zelboraf, which were both approved last year. The company also states that Yervoy has not shown much improvement in response rates, compared with earlier treatments using interferon and Dacarbazine. While it has increased survival by eight to ten months, it also exhibits severe side effects. According to OncoSec Medical CEO Punit Dhillon, "Response rates for Zelboraf exceed Yervoy, but the drug is limited to a certain patient population." Patients can also develop resistance to the drug; and when they discontinue treatment, melanoma can reoccur.
A successful regulatory approval process for either treatment could greatly reward OncoSec Medical shareholders. While investments in early-stage biotech companies can be risky, the risk in investing in OncoSec Medical is mitigated by two factors. The first factor to consider is that OncoSec Medical is focusing on new drug delivery systems, not new drugs. The second factor to consider is that OncoSec Medical is hedging its bets by developing two alternative treatments. Unlike the other two companies I present below, OncoSec's advantage is that the company doesn't have the higher regulatory hurdle of developing or marketing a new drug, but instead, has a proven efficient delivery system of an already-approved therapy. The company's true value is in its potential sales rather than current financials, like many development-phase companies. It currently has a market capitalization of $19 million and had $6.6 million in cash and equivalents at the end of Q1, 2012. Traded on the OTCBB, the security has the additional risk of lower liquidity and higher potential share price manipulation than its big board counterparts. However, I believe a risk assessment for those desiring a higher potential upside investment puts investment in this budding company into a positive light. OncoSec Medical is currently trading around $0.21, between a 52-week range of $0.12 and $1.00. I urge investors to consider OncoSec Medical if they believe in the viability of its approach to cancer treatment and are willing to accept the volatility the company's common shares could exhibit in the coming months.
AngioDynamics Focusing On NanoKnife
The second investment utilizing minimally-invasive cancer treatments has a radiofrequency ablation platform it has been developing. Radiofrequency ablation (RFA) is a procedure in which a probe is inserted directly into the tumor. The probe is energized once it is in the tumor, and monitored by ultrasound. The surrounding tissue is heated as a result of resistive friction, and by carefully heating the area to between 50°C and 100°C, the cancer cells are destroyed.
AngioDynamics (ANGO) focuses on RFA with its strong line of devices and supplies for a variety of treatments, including targeted tumor ablation and pain relief. Its flagship device, the NanoKnife System, has received FDA 510K clearance for soft tissue surgical ablation. In January 2012, the company faced a setback when it was forced to recall $3.5 million worth of products because an update on software violated FDA approval procedures. The company was able to resume shipments quickly, but the financial impact was considerable. The company's StarBurst RFA device, an RFA device for treating smaller lesions, has not yet received the FDA's 510K clearance, but has received the CE mark for sales in the EU, where it can be used to treat a variety of cancers. The company had previously received FDA approval for its NeverTouch Direct Procedure Kit (which is used in conjunction with its VenaCure EVLT Laser Vein Ablation System). It also completed a $355 million acquisition of Navilyst Medical, which could substantially enhance its presence in the vascular access market.
AngioDynamics finished its fiscal year with a mixed performance. The top line was encouraging, but there is clearly more work to be done on controlling costs. Revenue rose by 3%, but organic growth amounted to 10% if you exclude the impact of Navilyst. Vascular sales were up by 23% (10% organic), but oncology/surgery sales plummeted by almost 40%. The company's gross margin fell by four points, and though adjusted margins were better, there is much work to be done in improving them. The company reported less than 3% growth in EBTIDA. The encouraging aspect of the results was the 17% growth in sales of VenaCure EVLT systems, and this establishes the foundation for further sales of high margin disposables amounting to about $300 for each procedure. There was also an impressive 54% growth in NanoKnife sales. Bard (BCR) is the dominant player in the vascular access market, with a 70% market share and a wide range of offerings. Bard should do much better in fluid management (about 60% of Navilyst), where the company has a 60% market share and a big lead on competitor Merit Medical (MMSI).
Management is concentrating on NanoKnife and the pancreatic tumor ablation market. This makes a lot of sense, because pancreatic cancer represents a fairly large market where traditional treatments, like radiation and drugs, have not been particularly effective. This is a disciplined approach, and much preferable to squandering resources and time investigating a much broader range of tumors. AngioDynamics is currently trading around $12.48, between a 52-week range of $10.34 and $16.39. Investors should watch this company closely and be prepared to buy if there are more favorable developments, if the stock dips to an oversold position, or if technical analysis indicates a chart breakout.
Celsion Focusing On ThermoDox
The third company I wish to present is Celsion Corporation (CLSN). Celsion is concentrating on a new drug-delivery system that delivers an approved and well-established drug. The product is called ThermoDox, and the therapy is a lysolipid thermally sensitive liposome (LTSL) encapsulation of doxorubicin (which is approved and widely used in chemotherapy). It is infused intravenously and can be used in a large number of heat treatments. LSTL has the ability to contain the chemotherapy agent in a trapped and inert condition within the body. Radiofrequency ablation is then used to raise the temperature of the targeted area to just above body temperature, and heat activation releases the chemotherapy agent from the encapsulation. Chemotherapy agents are often highly toxic with strong side effects, which will be reduced by this treatment. Because the heat is applied to a targeted area, the agent is active only in the targeted region. The company says that testing on animals has shown that up to 25 times more doxorubicin is delivered to the tumor, compared to conventional intravenous methods.
Although the delivery system can be used in a variety of cancer tumors, clinical trials have focused on hepatocellular carcinoma (HCC), or liver cancer, which often results from long-standing hepatitis C. It is estimated there are around 750,000 cases every year around the world, of which 33 % could be treated using this treatment. Heat treatment is particularly important in the case of HCC, because liver cancers are located in close proximity to major arteries and surgery carries the risk of damage to the arteries. Heavy bleeding is often a primary cause of death in liver cancer surgery.
Celsion is continuing with phase III trials and expects to complete them by the end of this year. Because of the reduction in the recurrence rate in intermediate patients with HCC, ThermoDox is expected to quickly gain acceptance from liver cancer surgeons. In addition, the treatment has been granted Orphan Drug status, which means that it is protected from generic competition for a number of years. Rough estimates say that sales in Japan could reach $20 million in a few years, and sales in Europe and the U.S. could push this figure 50% higher. Because Asia and China in particular have a much higher incidence of liver disease, the revenue potential from that region could be as much as the rest of the world put together. The company already has a licensing deal in Japan and its partner, Yakult Honsha, will pay $4.5 million in fees and share development costs of $7 million. Celsion signed a deal with China's Zhenjian Hisun Pharmaceutical in May to manufacture ThermoDox, and Zhenjian Hisun is funding the initial production of ThermoDox by way of a loan.
For the quarter ended June 30th, 2012, Celsion reported a net loss of $6.1 million. For the first six months of 2012, the company reported a net loss of $12.3 million. As of June 30th, 2012, the company held $24 million in cash and equivalents. To boost its funding, the company entered into a $10 million loan facility with Oxford Finance LLC and Horizon Technology Finance in June 2012. The company will receive $5 million upon closing the deal, and the remaining $5 million would depend on the results from the HEAT study. The company believes that it has enough funding to see it through the pre-commercialization phase and the preparation for a New Drug Application (NDA). Celsion is currently trading around $5.83 with a 52-week range of $1.63 and $5.98. Investors should watch Celsion closely for any new developments surrounding its phase III trials for ThermoDox, as positive news could send this stock soaring well above its 52-week high.
The three companies I have presented are showing a great deal of promise in fighting cancer. Each of the three companies has something different to offer for different investor types, from those looking for a high risk and high reward investment, to those looking for a more stable investment. My research is intended to be used as a starting point. Investors should perform further research by analyzing SEC filings, clinical trial data and targeted market groups.