A surge in the volume of papers, studies, and other research suggest a rising demand for effective treatments to prevent the recurrence of cancer. To be specific, Galena Biopharma's (GALE) NeuVax, for the treatment of recurrence in women with breast cancer, has taken the market by storm with its 360% return in 2012. The company's clinical biomarker data combined with recent articles published by the prestigious Lancet (Volume 13, Issue 7) provide further details as to why we should be optimistic and hopeful that cancer recurrence rates and death rates might be seeing some improvement due to the progressions of the space.
Without getting too complex with biotechnology jargon, the measurement of circulating tumor cells (CTCs) is proving itself to be very important in the early detection of relapse. These are cells that have detached from the primary breast tumor and then circulate in the bloodstream. Over the last year there has been significant and convincing data regarding the role and connection of these cells (CTCs) to metastatic breast cancer. There have been two different studies; REMAGUS 2 and SUCCESS that suggest the presence of CTCs could predict poor survival in patients with early breast cancer.
In an article published by The Lancet, blood samples were taken from 302 patients and CTC levels were then compared to survival data. In 73 patients one or more CTCs were found and predicted decreased progression free survival (PFS), hazard ratio (HR), and overall survival (OS), which interestingly enough is comparable to historical recurrence trends. The authors of the study have shown how higher CTCs could be meaningful in predicting or identifying the presence of metastases, although more testing is needed to determine if these cells can be used as biomarkers.
On Friday Galena provided data that supports the findings of Lucci and colleagues, with news regarding its lead candidate that shows a reduction in CTCs among vaccinated patients. The announcement of data came from a poster in which the company is presenting at a conference in Maryland. In the study Galena measured CTCs from blood samples because of the belief that increased levels often predict the likelihood of recurrence, which correlates with the findings of Lucci and colleagues.
Galena's most significant data, which created upside of 7% on Friday, was that patients treated with NeuVax not only had a lower chance of recurrence but also were also more likely to show a decrease in CTCs than the control group. Due to previous phase 1/2 data, we already knew that the vaccinated group's outcome was much more favorable than the control group. However, with 16/26 patients seeing a decrease in CTCs we can also see a direct correlation between the cells and recurrence. We now know that NeuVax may be useful in decreasing CTCs. If studies continue to show a connection between CTCs and recurrence then perhaps Galena will further test the vaccine as a treatment to decrease CTCs in patients with other HER2-related cancers.
The data found from both Galena and the studies conducted and published by The Lancet provide a possible answer to why 25% of patients with node-positive breast cancer will relapse within three years, despite no evidence of disease after surgery and chemotherapy. In Galena's press release the company's CEO, Dr. Mark Ahn, stated, "The data presented today shows that treatment with NeuVax reduces CTCs and therefore may prevent growth of future micrometastasis, lending support to the idea of using the woman's immune system to prevent relapse of her breast cancer." As a result, the news was a pleasant surprise for Galena and its quest to tackle this massive market with the use of NeuVax.
Ever since Dendreon (DNDN) blasted onto the scene with its prostate cancer vaccine, Provenge® we've known the potential of using the body's immune system to fight cancer. The CTC news on behalf of those studying its connection to cancer and also Galena is not only a win for companies with breast cancer immunotherapy vaccines, but also immunotherapy as a form of treatment for cancers in general.
One of the reasons that I purchased shares of Galena back at the end of January 2012 was because I felt it was a victim of its own industry. In late 2011 Dendreon's shares fell and are yet to recover as investors, and physicians, poked holes in the technology of its promising treatment. And although it has continued to fall in 2012 by 50%, immunotherapy companies such as Galena, Celldex Therapeutics (CLDX) and NewLink Genetics (NLNK) have been among the best performers in 2012 as they continue to test the boundaries of immunotherapy.
Galena Biopharma's Q1 rise from $0.45 to over $3.50 was a great rally, but after a round of financing the price per share fell to near $1.00 in Q2. It has slowly continued to trade with strength higher ever since, now at $2.15. The stock has not only maintained its large gains, but has continued to rise, as other big time early year performers such as Threshold Pharmaceuticals (THLD) has lost 40% in the last month and Peregrine Pharmaceuticals (PPHM) has seen an epic decline. Ultimately, clinical studies are to explore and learn about the potential of a product/drug. And Galena is learning and finding some very encouraging information regarding its lead product and its upside. The potential multi-billion dollar drug may still have a ways to go, but as of now, everything's looking good and investors will eagerly await the final data of its phase 2 NeuVax trial in December of 2012. As an investor, I am anxious to see what we may learn next as NeuVax may lead to an advance in the standards of care for breast cancers and other cancers.