Breaking historical trend, Advaxis Wednesday hosted its first beginning of year traditional business outlook for 2013. As discussed in the company’s conference call, this is one of several initiatives Advaxis has lined up to advance its position in the biotech industry, and more specifically in the cancer treatment field.
“We’re evolving as a biotechnology company, for the positive. We felt it was important to improve our transparency and frequency of interaction with you, our investors,” Advaxis CEO Tom Moore said during the call.
Before addressing objectives for the upcoming year, the company highlighted its 2012 achievements, which included securing access to a $10 million committed equity line and reducing its non-affiliated debt 80%, or by $7.2 million.
On a clinical front, Advaxis released positive preliminary data from an ongoing phase 2 trial of ADXS-HPV, the company’s immunotherapy drug candidate for the treatment of cervical cancer. The company expects that final data will be consistent with those already reported. ADXS-HPV was awarded the 2012 Best Therapeutic Vaccine by Vaccine Industry Excellence.
Additionally, Advaxis reported positive data for first cohort of its CIN 2/3 trial, and completed the second dose cohort, which it plans to release in the second quarter of this year.
“With all the progress made in 2012, I believe we’re poised for an even better, in fact a transformational year in 2013, and that we’re ready to move to the next stage of growth, which we believe will both drive value into our Advaxis-HPV product candidate while increasing shareholder value at the same time,” Moore stated.
Moore explains that Advaxis has reached a level in which the company needs to foster and better communicate the value and potential of its technology platform and clinical data to investors, key thought leaders and potential partners. To do this, the company has expanded its outreach efforts, initiated global market opportunity assessment, consolidated its legal services, and launched a proactive investor relations program.
Moving forward, Advaxis has two primary goals for 2013: the continued advancement of ADXS-HPV toward registration development program, and to strengthen the company’s financial position.
It is estimated that 12,000 women in the U.S. will be diagnosed with cervical cancer in 2012. Of these, approximately 4,000 will progress to refractory recurrent or metastatic cervical cancer, the second leading cause of cancer death in women around the world. HPV infection is strongly associated with a wide range of cancers and accounts for 7% of all cancers.
“The opportunity to apply ADXS-HPV to those other HPV-associated cancers makes for an attractive long-term mission for the company, and its potential partners, and investors,” Moore said.
Dan O’Conner, senior vice president, and chief business development and legal officer of Advaxis, citing Pharma.org, noted that there are few immunotherapies in development to treat refractory recurrent cervical cancer.
“Although companies have been focused on developing preventative vaccines, very few companies have been actively engaged in the development of immunotherapeutic options for the treatment of recurrent refractory cervical cancer,” O’Conner said. “All of this creates an opportunity for Advaxis.”
Current treatment options are limited and are often associated with high levels of significant toxicity. Advaxis’ goal is to advance its research and development to reach an indication for ADXS-HPV as an alternative treatment to current cervical cancer therapies. If approved, this immunotherapy would be the company’s first marketed product.
“Our goal is nothing less than to become the industry leader in HPV-associated cancer research and immunotherapy drug development. We view HPV-associated diseases, starting with cervical cancer, as our core opportunity …” Moore stated.
Robert Petit, vice president of clinical operations and medical affairs at Advaxis, acknowledges the unmet need for an effective, well-tolerated, non-chemotherapy treatment option without toxicity.
“The ideal therapy for these patients would not only be effective, but it would be able to generate durable response and prolong survival with a significantly better side effect profile,” Petit stated. “Our current data provides proof of concept that suggests we might just have this much needed effective treatment with a significantly better safety profile than high-dose combination chemotherapy. Now, we must work to confirm these preliminary findings, optimize the regimen, and help to find its proper place in the treatment of cervical cancer to continue clinical trials.”
The company’s 2013 clinical and regulatory objectives are as follows:
• Analyze phase 2 data and work to optimize dose and schedule
• Proceed with clinical plan with the advice and collaboration of global thought leaders in cervical cancer
• Finalize clinical plan and consult with regulatory authorities to advance ADXS-HPV to registrational trials
For more information visit www.advaxis.com
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