In response to some recent successes by several companies operating in the cervical cancer space, we are issuing a two-part special report exploring pre-cervical cancer and CIN. Part II of the report identifies several disruptive technologies that may overcome the challenges of mainstream treatments. After some some favorable recent news from Advaxis, we pay particular attention to cancer immunotherapy vaccination, an area that is rapidly drawing interest.
Part I of this report surveyed the conditions and market opportunities, including: a description of prevalence and a look into the advantages and shortcomings of mainstream treatments.
If you missed Part I, click here.
In response to inconclusive results studying the outlook of several mainstream treatments, coupled with the knowledge of the harsh side effects, efforts to discover alternate methods of treating CIN are gaining steam.
According to the American Cancer Society, recent studies into the use of medications to treat CIN have have yielded promising results. In one study, patients with CIN II or CIN III took the drug diindolylmethane (DIM) for 12 weeks, and follow-up testing did show improvement – in some women, the CIN had gone away completely.
CIN has also been treated with the drug cidofovir, applied to the cervix. In more than half of the treated women, the CIN resolved completely. Still, the ACS has determined more studies are needed before these drugs can become a standard treatment.
The emerging field of cancer immunotherapy vaccination is one area of particular interest to healthcare providers and investors. Immunotherapy stimulates one’s own immune system to work harder, in many instances by giving components – such as man-made proteins – to the immune system.
Advaxis (OTC BB: ADXS.OB) is a Princeton-based clinical-stage biotechnology company developing cancer and infectious disease immunotherapies. The company’s novel platform technology uses live, attenuated bacteria, which are bio-engineered to secrete an antigen/adjuvant fusion protein. The process directs the powerful immune response to the bacterium to the cancer instead.
In 2012, the company’s ADX-HPV immunotherapy construct was selected as having the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards. Advaxis’ ADXS-HPV construct is in Phase II development for the treatment of CIN II/III and recurrent/refractory cervical cancer, as well as for HPV-related head and neck cancers. The company is sponsoring a CIN II/III trial in the US and a recurrent/refractory cervical cancer trial in India.
Advaxis announced in late February that it had completed the first of three dose cohorts in its single blind, placebo-controlled Phase II dose-escalation study assessing the safety and efficacy of ADXS-HPV in the treatment of CIN II/III. The Advaxis pipeline also includes constructs in pre-clinical development for the treatment of prostate and breast cancers, as well as for other HER2-over-expressing cancers such as gastric, bladder, pancreatic, brain, and ovarian. The company also has a construct that is in a Phase I veterinary trial for the treatment of canine osteosarcoma in large breed companion dogs.
Tom Moore, Chairman and CEO of Advaxis, writes that chemotherapy, radiation, and surgery can be effective against cancer, but can come at a great cost to the patient. Moore and the ACS caution that chemotherapy and radiation can have long-lasting side effects that span over months or years. Moore believes the next generation of cancer treatments is intended to be as effective while more narrowly targeting the rapidly dividing cells that characterize cancer.
Doctors have explored the use of the immune system in fighting certain cancers since the discovery of the disease. Even in the late 1800s, before the immune system was well understood, William Coley, MD, a New York surgeon, noted that getting an infection after surgery seemed to help some cancer patients. Dr. Coley had some success treating cancer patients by infecting them with certain kinds of bacteria, though the implementation of radiation therapy pushed his work away from mainstream.
The medical community has learned a great deal about the immune system since then, and in the last few decades, immunotherapy has proven useful in treating several types of cancer, according to the ACS.
In her Huffington Post article entitled “What You Don’t Know About Cancer — Hope on the Horizon,” award-winning author and activist Marlo Thomas writes that we have recently obtained the “blueprint” of the cell through DNA sequencing, which opens up the doors to many new cancer treatments that we did not have before. Thomas writes that scientists refer to recent breakthroughs in immunotherapy as a “renaissance.” Thomas has witnessed at least one breast cancer specialist express “hopefulness about doctors’ increased ability to treat cancer effectively without leaving the patient debilitated through invasive surgery.”
Any one who works with vaccine development knows the potential that Advaxis has to offer. One of my friends who works at a big pharma thinks that Advaxis should have a partner by the end of 3rd qtr. of this year. With 15 constructs and the science that works, he thinks that the company is going to make headlines going into 2013.