Long Galena Biopharma: Creating A New Breast Cancer Treatment Alternative

| About: SELLAS Life (SLS)
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It's a sentence no woman wants to hear: "I'm sorry, but you have breast cancer." The diagnosis is a devastating one, yet one that thousands of women receive every year. For all the "awareness" and attention the disease garners in the media, the knowledge that you or someone you love has breast cancer comes as a major shock.

Sadly, while deaths from heart attack, stroke and infectious disease have plunged due to new treatments and better preventative measures, deaths from cancer have not. Lewis A. Chodosh of the Perelman School of Medicine at the University of Pennsylvania states, "We have now reached a tipping point in history at which deaths from cancer will soon surpass those from cardiovascular disease. In this regard, breast cancer holds the dubious honor of having become the leading cause of cancer mortality among women worldwide."

Adding to this troubling fact is the reality that in many cases, women are not adequately informed of their surgical treatment options. A revealing study from the University of North Carolina questioned breast cancer survivors about their understanding of their disease and how much information their doctors had provided them with. Researchers found that less than half of the respondents knew that a lumpectomy, a procedure which removes the tumor rather than the breast itself, leads to higher rates of recurrence than does a mastectomy. Only 56% knew that survival rates were nearly equal with both options. Even more disturbing, however, was the fact that less than half of the women said their surgeons had even asked them which option they preferred, indicating that perhaps doctors make assumptions about a patient's wishes that may not necessarily be the case.

The study's lead author, Dr. Clara Lee, an associate professor of surgery and director of surgical research at UNC's School of Medicine in Chapel Hill, believes that women who do choose mastectomy were less likely to be given the treatment they prefer. "Patients reported that their doctors were more likely to discuss breast conservation therapy and its advantages than mastectomy," said Lee. "And many women did not recall being asked for their preference. We know from other studies that doctors don't always know their patients' personal preferences, so they may not be fully aware when a woman truly prefers mastectomy,"

Why is there a breakdown in communication over such a life-altering decision? Possible explanations are that the surgeon didn't properly explain the options, or perhaps didn't explain them in a way the patient could understand. Or perhaps the woman's distress during such an emotional time prevented her from even absorbing the information presented to her. Regardless, it is crucial that doctors strive to communicate with their patients and ensure that they truly understand all options.

Yet even with such gaps in communication between doctor and patient, there is much to celebrate as we look ahead at new treatments currently on the horizon. In the past several years, researchers and physicians have made great strides in the fight against this insidious disease. Compared to the limited choices of even a few years ago, today's woman faced with the agonizing decision of how best to treat and manage her cancer has numerous options. A quick Internet search or discussion with cancer survivors will surely turn up stories of surgery, chemotherapy, radiation, hormonal therapy, targeted therapy, perhaps complementary or holistic treatments. But as we head deeper into the 21st century, a promising new cancer treatment is beginning to make headlines.

This exciting development is the advent of immunotherapy, which specifically targets and attacks cancer cells. Rather than rely on outside factors such as radiation or the surgeon's scalpel to remove tumors or shrink tumor cells, immunotherapy, or a cancer "vaccine", uses the patient's own immune system to fight the invading cancer cells. According to the National Cancer Institute, "Cancer treatment vaccines are designed to treat cancers that have already developed. They are intended to delay or stop cancer cell growth; to cause tumor shrinkage; to prevent cancer from coming back; or to eliminate cancer cells that have not been killed by other forms of treatment."

The benefit of such a therapy is obvious: while chemotherapy and radiation are effective in killing cancer cells, they also kill the surrounding healthy cells and tissue, resulting in sometimes devastating side effects for the patient. Therefore, a treatment option that would specifically target only the metastasized tumor cells while not harming healthy tissue has long been the Holy Grail of cancer treatment.

While the idea of a therapeutic cancer "vaccine" has been posited in theory for over a century, not until recently has this vision started to become reality. In April 2010 the FDA approved the first cancer treatment vaccine, Dendreon's (DNDN) Provenge, for the treatment of metastatic prostate cancer, followed by Bristol-Myers' (BMY) Yervoy for melanoma the following year, creating a buzz in the both the medical and scientific communities as well as fueling great interest in the arena of commercial investment in the development of additional vaccines.

So it is with great anticipation that scientists and investors monitor the latest research, clinical trials and published results coming from several prominent biopharmaceutical companies. Every week, every month brings new and exciting developments, sparking the imaginations of medical practitioners and the hopes of cancer sufferers worldwide. One such company that seems poised for success is Galena Biopharma (GALE), whose self-proclaimed mission is focused on "discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics". Galena, formerly of RXi Pharmaceuticals, changed its overall business strategy as it began to focus on cancer vaccines. One such vaccine currently in the pipeline is NeuVax, an experimental treatment targeting a common type of breast cancer.

According to data from the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer each year, 25 percent of which test positive for the HER2 receptor. Unfortunately, once the cancer is in remission, only 25 percent are eligible for Roche-Genentech's (OTCQX:RHHBY) breakthrough drug Herceptin, the current gold standard of treatment following a patient becoming cancer-free. For the majority of women who don't qualify, however, the news that there are currently no further options to prevent a recurrence comes as a painful blow. Clearly there is a great need for an alternative form of treatment for many thousands of women.

Enter NeuVax, which targets HER2-positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to prevent the cancer from returning. The hope is that NeuVax could delay disease recurrence and progression in breast cancer patients whose tumors express only low to intermediate levels of the HER2 receptor, and who thus are ineligible to receive Herceptin, which blocks that receptor. If NeuVax can successfully spur the body's own killer T-cells to attack cells expressing any level of HER2, it will certainly fill a great need for these women. Aside from the many women who could benefit from this type of drug, it could potentially mean enormous profits for Galena and its investors as well as a boon to the pharmaceutical industry as a whole.

Considering the fact that if Herceptin, which is limited in its ability to treat just 25% of breast cancer survivors, is currently doing nearly $6 billion in annual sales, imagine the potential of NeuVax, which would be able to target the other 75%. The upside potential for both the company and its investors is enormous, possibly offering a once-in-a-lifetime opportunity. This could propel Galena into further research and make even greater strides towards healing people and bettering their quality of life.

Thus far Galena has had great success in Phase I/II trials, reporting data indicating that NeuVax could indeed potentially aid patients in remaining disease-free. In late January, the company announced their Phase III trial named PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment), well ahead of its original planned date of April 2012. The trial design has been updated to include current National Comprehensive Cancer Network guidelines and recently received Special Protocol Assessment (SPA) concurrence from the FDA. If the results of the final trial are as promising as they were in the previous trials, the data will be presented to the FDA for approval…and the breast cancer sufferers everywhere will have a powerful new weapon in their arsenal.

With around 100 trial sites and over 700 patients throughout the U.S., Canada and Europe, the eyes of the scientific and medical community are anxiously awaiting the outcome of the clinical trials. The implications for breast cancer sufferers are enormous; so too are the ramifications for cancer patients in a larger sense. With each successful breakthrough vaccine, researchers inch closer and closer to achieving the ultimate goal of a vaccine targeting every form of cancer.

Once nothing more the product of wishful thinking, cancer immunotherapy, though still in its infancy, is emerging as one of the most exciting and promising medical breakthroughs of the century. Galena is a play on the hope for greater success in this area.

Disclosure: I am long GALE, OTCQX:RHHBY.