Immunotherapy, the enlisting of the body’s own immune system to more efficiently attack cancer and other diseases, has become a major point of attention all over the world as a dramatic new approach to disease treatment. It’s a science that is still developing, with a growing pipeline of new immunotherapy drugs just now undergoing initial trials, but the potential is immense. Instead of blasting cancer patients with a cocktail of poisons and radiation, hurting good cells as well as bad, immunotherapy offers the hope of focusing more energy much more accurately and efficiently. The result could be a day when a whole range of cancers can be treated effectively and rapidly, with almost no negative side effects.

An example is Advaxis, a New Jersey based biotech company that is helping to lead the immunotherapy charge with a number of developing drug candidates. One of their prospects, ADXS-HPV, for use with women suffering from recurrent/refractory cervical cancer who have not had success with traditional cytotoxic therapy. The drug has been undergoing the final part of a Phase II study, and recently updated results have been extremely encouraging.

From a safety standpoint, the drug continues to be well-tolerated, a strong point of the immunotherapy approach. Similar patients undergoing chemotherapy, by comparison, virtually all have fairly severe adverse effects. In addition, the drug is showing significant efficacy in early results, with major improvements in initial survival rates. Although the final results still have to be reported, ADXS-HPV appears to be an effective weapon against cervical cancer, without the toxicity and dangerous side effects of traditional chemotherapy. With the next update due in June of 2013, a partnership of some sort is not out of the question.

For more information visit www.advaxis.com

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Advaxis, a biotech company developing the next generation of immunotherapies for cancer and infectious diseases, today said its board of directors has elected Dr. Robert Petit, currently vice president of Advaxis’ Clinical Operations and Medical Affairs, to the position of chief scientific officer. In addition, the company named Daniel J. O’Connor, currently senior vice president and chief legal and business development officer, to the position of executive vice president.

The promotions, effective May 3, 2013, reflect the men’s performance in the past and expected roles in assisting Advaxis in its future growth initiatives.

“The excellent contributions Robert and Dan have made to Advaxis have led to the board’s decision to elevate their status within the company,” Thomas A. Moore, chairman and CEO of Advaxis stated in the press release. “We look forward to working with our skilled and highly experienced leadership team during the next stage of development at Advaxis.”

Advaxis will hold its Annual Meeting of Stockholders June 5, 2013, at 10 a.m., Eastern Daylight Time, at the Princeton Marriott, 100 College Road East, Princeton, New Jersey 08540. Stockholders of record of the company’s common stock at the close of business April 15, 2013, are entitled to receive notice of, and to vote at, this year’s meeting.

For more information visit www.advaxis.com

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Advaxis, a clinical-stage biotech company developing immunotherapies for cancer and infectious diseases, today told investors of encouraging preliminary data from the Phase 1 dose escalation study evaluating the safety of ADXS-cHER2 in companion dogs with Her2/neu overexpressing canine osteosarcoma being conducted at the University of Pennsylvania School of Veterinary Medicine.

The primary goal of the study is to establish the maximum tolerated dose of ADXS-cHER2. Preliminary data from the first two dose groups (3 dogs each) show that ADXS-cHER2 at either 1 x 10(8) or 5 x 10(8) cfu is well-tolerated. 100% of dogs experienced 1 or more mild (Grade 1) side effects consistent with cytokine release syndrome observed at the time of administration (fever, increased blood pressure, malaise, nausea, and/or vomiting). Early data also suggest that Her2/neu expression in canine osteosarcoma may denote a more aggressive phenotype.

The study is also being used to determine progression-free survival and overall survival. Early results from the first two dose groups (6 dogs) show a significant survival advantage in dogs that received ADXS-cHER2 compared to 6 dogs whose owners elected not to participate in the trial but who were followed for survival (p=0.01).

Dr. Nicola Mason, lead investigator in the Penn canine osteosarcoma study, plans to expand the trial to three additional sites in the United States. ADXS-cHER2 booster vaccinations will be given to evaluate the effects of maintenance immunotherapy.

“The preliminary data from this study are encouraging,” stated Dr. Nicola Mason. “The dogs that have been treated with ADXS-cHER2 are doing very well and although the numbers of vaccinated dogs are small, they do appear to be doing better than dogs with Her2/neu overexpressing tumors that did not receive the vaccine. I am extremely excited to expand this trial, make the vaccine available to more dogs, and determine its therapeutic benefit in dogs with this highly aggressive tumor type.”

“These preliminary findings suggest that the second Advaxis immunotherapy to be evaluated in a clinical setting (in addition to ADXS-HPV) may also improve survival in cancer. Furthermore, a veterinary oncology indication could potentially open an entirely new market for Advaxis Lm-LLO immunotherapies and further validates the versatility of our technology platform and constructs,” commented Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis.

For more information, visit www.Advaxis.com

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Advaxis, a clinical-stage biotech company developing immunotherapies for cancer and infectious diseases, has entered into a Memorandum of Understanding (MoU) with Taiwan-based FusionVax under which Advaxis, upon signing a definitive agreement, will exclusively license its lead clinical stage product candidate, ADXS-HPV, to FusionVax for distribution in Asia.

FusionVax develops immunotherapies for the treatment of HPV-associated cancers such as cervical cancer, which is the leading cause of death in Chinese women, says company CEO Dr. HunChi Lin. FusionVax develops its licensed technologies through collaborations with reputable medical centers in Asia including: National Taiwan University, Taipei Medical University, and Mackay Memorial Hospital Medical Center.

“FusionVax is well-positioned to further develop ADXS-HPV clinically and to realize its commercial value in Asia across multiple HPV-associated cancers,” Daniel J. O’Connor, senior vice president, chief legal and business development officer of Advaxis stated in the press release.

Per the MoU, FusionVax will hold the exclusive licensing for the Asia territory, exclusive of India, for all indications, in exchange for an up-front payment to Advaxis, certain event-based financial milestones, an annual exclusive licensing fee, and an annual net sales royalty in countries with issued patents. In exchange for the up-front payment, Advaxis will provide FusionVax an equal amount of Advaxis common stock.

FusionVax will be responsible for conducting clinical trials and pursuing commercialization of ADXS-HPV in Asia, for which Advaxis will pay FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than 1 percent.

“With five studies currently in the field in four indications, we continue to broaden our data. This MoU is the first milestone on Advaxis’ path to future licensing opportunities,” commented Thomas A. Moore, chairman and CEO of Advaxis.

The companies will share all data generated from their respective clinical trials.

For more information, visit www.Advaxis.com

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Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer.

Coordinated by the Brown University Oncology Research Group (BrUOG), this study will expand the clinical investigation of ADXS-HPV to now a third tumor type, following cervical cancer and head and neck cancer. ADXS-HPV has been safely administered to more than 190 patients with HPV-associated diseases, and has demonstrated clinical benefit as a single agent or in combination with chemotherapy.

This non-randomized, open-label, multi-center study was designed to assess the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response.

“This milestone marks the beginning of the development of ADXS-HPV in diseases beyond cervical cancer. It also will provide valuable insight into the combination of ADXS-HPV with concurrent radiation and chemotherapy,” commented Dr. Robert Petit, VP of Clinical Operations and Medical Affairs at Advaxis.

For more information, visit www.advaxis.com

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Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, announced today that Daniel J. O’Connor, Senior VP, Chief Legal, and Business Development Officer at Advaxis, will be presenting at the BIO International Convention (BIO 2013) in Chicago, IL, later this week.

On April 22 at 3:00pm, Mr. O’Connor will provide a review of the progress of ADXS-HPV, Advaxis’ lead drug candidate in Phase 2 clinical development for recurrent/refractory cervical cancer. Updated data regarding this exciting compound will be disclosed at the 2013 American Society of Clinical Oncology Annual Meeting in June.

Recognized as the largest global event for biotechnology and pharmaceutical industries, the BIO International Convention attracts many of the biggest names across all major continents. This year’s convention was organized to provide valuable networking and partnering opportunities, as well as generate insights and inspirations on current trends that are essential in the development of innovative and better technologies for the future.

For more information, visit www.advaxis.com

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Advaxis, a clinical-stage biotech company developing next generation immunotherapies for cancer and infectious diseases, will exhibit two abstracts related to ADXS-HPV (ADXS11-001), the company’s lead clinical stage product candidate, in a poster presentation at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 31 – June 4, 2013, at the McCormick Place Convention Center.

Abstract #5529, titled “ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a P2 study in Indian women with recurrent/refractory cervical cancer,” was selected for presentation at the Poster Discussion Session: Gynecologic Cancer. This poster will include updated safety, tumor response, and survival data from the ongoing randomized phase 2 trial of ADXS-HPV with or without cisplatin being conducted by Advaxis in India.

Abstract #TPS3121, titled “A phase 2 study of live-attenuated Listeria monocytogenes immunotherapy (ADXS11-001) in the treatment of persistent or recurrent cancer of the cervix (GOG-0265),” will be presented during the Developmental Therapeutics – Immunotherapy Trials in Progress General Poster Session. This poster will describe the trial design for the ongoing phase 2 study being conducted by the Gynecologic Oncology Group (GOG) in the United States.

“We are pleased to have the opportunity to present the final 12-month survival and other relevant data from our 110 patient trial of ADXS-HPV in recurrent/refractory cervical cancer at ASCO’s annual meeting,” Dr. Robert Petit, vice president of Clinical Operations and Medical Affairs at Advaxis stated in the press release. “ADXS-HPV immunotherapy offers the promise of an effective and well-tolerated treatment for cervical cancer that employs the patient’s immune system to fight the cancer. We are encouraged by the interest that our colleagues in GOG have in joining our efforts to evaluate the potential of ADXS-HPV in cervical cancer, through the conduct of GOG-0265.”

Abstracts will be released on www.asco.org at 6 p.m. May 15, 2013.

For more information, visit www.advaxis.com

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The ongoing battle against cancer and infectious diseases in the human body has been compared many times to a type of war, involving strategies that are more alike than one might expect. The fight against cancer is a prime example. It is much like a war against infiltrating terrorists, with evolving strategies being developed as the threat is first recognized, then analyzed, and finally attacked in a variety of ways.

In the case of terrorists infiltrating a foreign country, a threat can exist long before it is finally recognized. Terrorists enter a country surreptitiously, recruiting others, growing in numbers and strength, all before enough damage is done inside or outside to trigger an alert. Once it becomes clear that something is seriously wrong, the nature and size of the threat must be more clearly determined. Only then can meaningful action be taken, and the longer it takes to recognize and analyze what is happening, the more damage can occur.

In the case of war, military action may take the form of high level bombing, but that invariably causes what is euphemistically called collateral damage, where good people are getting hurt or killed along with the bad. In the end, the best solution is to have maximum “intelligence on the ground,” where trained identification and action can be taken on a localized and high-precision basis, projecting the greatest power against exactly the correct targets.

In the case of cancer, a malignancy can begin and develop for some time, with few if any obvious symptoms, emphasizing the importance of early diagnosis. Once a problem is felt, a more exact diagnosis is needed to pinpoint the nature of the cancer. At that point radiation and chemotherapy is often applied, where finely tuned rays or chemical poisons are administered. It’s analogous to high-level bombing, since, in spite of advances in technology, many good cells and structures can get damaged or destroyed along with the cancer cells.

Immunotherapy, such as that being developed by Advaxis, represents the medical version of intelligence on the ground, where an individual’s own immune system is, in effect, trained to search out and destroy the bad cells. Everything is done at the cellular level, where effectiveness can be maximized, and collateral damage can be minimized or even eliminated. It is seen by many as the ideal solution, and the next big step in the treatment of cancer and infectious diseases. Advaxis is already developing a pipeline of immunotherapy products for cervical cancer, head and neck cancer, and other cancers, winning awards for their revolutionary developments.

For additional information, visit www.Advaxis.com

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ADXS tried to make a move on Monday as the stock consolidates following a climb of more than 400 percent. The move didn’t follow through on Tuesday, but the chart is on radar for increased activity with the stock price back over the 50-dma.

To view the video chart, visit the following link: http://www.qualitystocks.net/videocharts

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The advance of immunotherapy as a foundational tool in the ongoing fight against cancer and infectious diseases represents one of the biggest developments in modern medicine, alongside stem cell technology, non-invasive diagnostics, and transplant technology. Modern immunotherapy is just now emerging as a viable treatment option, and so its range of possible application is seen as being potentially immense.

Advaxis, a New Jersey based biotech company, is developing the next generation of immunotherapies for cancer and infectious diseases, using a novel approach. The company is bio-engineering a bacteria to secrete antigen/adjuvant fusion protein(s) designed to redirect the human immune response to the bacterium to go after cancer cells. It’s a unique Listeria platform technology that offers advantages, and is the basis for the company’s drug candidates. The company currently has over 15 distinct constructs in various stages of development. ADXS-HPV, their lead candidate, is being evaluated in a number of clinical trials for HPV (Human Papilloma Virus) associated diseases, such as cervical cancer, head and neck cancer, and anal cancer.

In February, 2013, Advaxis announced that the Brown University Oncology Research Group (BrUOG) will
be coordinating a Phase I/II study of ADXS-HPV in 25 patients with HPV-associated anal cancer. Multiple institutions will be involved in the study, which will evaluate both the safety and effectiveness of ADXS-HPV in combination with chemotherapy and radiation treatment. Cancer cells infected with HPV have the tumor associated antigen HPV E7, and the Advaxis drug causes antigen presenting cells to stimulate other immune cells to attack cancer expressing HPV E7. The company now has a series of clinical trials under study, including three Phase II trials, two Phase I/II trials, and three Phase I trials, significant for a small-cap biotech company.

For additional information, visit www.Advaxis.com

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Advaxis is a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases. The company’s immunotherapies are based on a novel platform technology that uses live, bio-engineered bacteria to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to fight off cancer and disease.

Earlier this week, Seeking Alpha published the following article featuring Advaxis: http://seekingalpha.com/article/1298241

The article titled “Drug Companies Have Rebounded From The Patent Cliff With Acquisitions Now On The Mind” provides an overview of the pharmaceutical industry and its challenges. Strong competition from generic drug companies are pressuring Big Pharma to produce a new pipeline of drugs, either through research & development or acquisitions. Based on activity in the market as the pharmaceutical industry moves beyond the hollow specter of the patent cliff, there is a definite interest in buying up companies with promising efforts.

Jonathan Yates, author of the article, wrote, “Advaxis has more than 15 constructs in various stages of development that are not only distinct, but many are in strategic collaborations with such heavyweights as the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institute, and others . . . Advaxis’ lead construct, ADXS-HPV, was honored as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards.”

While honors and awards light up a press release, investors only care about the glow from the bottom line. For the global market for immunotherapies from companies such as Advaxis and Dendreon, sales are estimated to be about $40 billion.

For more information, visit www.advaxis.com

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Advaxis, a leading developer of the next generation of immunotherapies for cancer and infectious diseases, announced today that an abstract has been accepted for oral presentation at The Society for Immunotherapy of Cancer (SITC) Cancer Immunotherapy Clinical Trials: Concepts and Challenges workshop being held next week at the National Institutes of Health Campus (Masur Auditorium) in Bethesda, MD.

The abstract titled “Early Therapeutic Cancer Vaccine Clinical Trial Development” will be presented on April 4 at 10:30 am during Session 1 by Dr. Robert Petit, VP of Clinical Development and Medical Affairs at Advaxis. Dr. Petit will describe Advaxis’ experience with conducting early clinical trials with therapeutic Lm-LLO immunotherapies.

“The selection of our abstract for presentation at SITC provides an opportunity for Advaxis to share our experience in introducing Lm-LLO immunotherapy in a global clinical trial setting where there is great medical need,” stated Dr. Petit. “We are working toward a future when immunotherapy can fully take its place alongside conventional treatments in the global battle against cancer.”

For more information, visit www.advaxis.com

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The human body’s primary defense against diseased cells is a strong immune system, a complex system of cellular level processes that has evolved to both identify and take action against foreign or diseased cells, including cells developing into cancer cells. It is believed that the human body is constantly generating at least some cancer cells, but that the body’s immune system is generally able to handle them. However, a defective immune system, a system compromised by a genetic problem, or environmental factors, or weakened by changes related to the aging process, leaves the body vulnerable to internal or external attack.

For example, it appears that an aging immune system is simply less effective in dealing with cancer cells, although the reasons for this are still not fully understood. As a result, cancer is much more common in people over 60. The immune system must have the ability to both identify and destroy problem cells, and if either of these roles is compromised, the result can be full blown disease.

But science is now learning how to leverage the many remarkable abilities of the human immune system, tweaking it in such a way as to help it identify and then take successful action against cancerous and other corrupted cells. Immunotherapy is just now beginning to appear on the public stage with treatments that partner with the body instead of fighting it.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. The company’s immunotherapies are based on a novel platform technology involving the use of live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) that redirect the powerful immune response all human beings have to the bacterium to the cancer itself. In effect, the approach puts cancer in the line of fire.

ADXS-HPV, the company’s main anti-cancer drug, is currently being evaluated in 5 clinical trials for HPV-associated diseases, including cervical cancer, head and neck cancer, and anal cancer, and the company has over 15 distinct constructs in various stages of development.

For additional information, visit www.Advaxis.com

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Biotech small-cap Advaxis has been nominated for the Vaccine Industry Excellence (ViE) Award sponsored by Novartis Vaccines and Diagnostics. The ViE award recognizes companies and individuals that have demonstrated influential accomplishments and contributions to the vaccine industry within the prior 12 months.

Nominees are selected according to criteria such as the company’s ability to advance their business from early stage to mature, create a quality and diverse pipeline, achieve clinical advancements, establish significant partnerships, and successfully secure funds for continued growth.

Advaxis chairman and CEO Thomas A. Moore detailed the company’s initiatives leading up to its second straight nomination for the ViE award.

“We are delighted to be nominated in two consecutive years for a ViE award,” Moore stated in the press release. “In 2012, we made tremendous progress advancing our lead program in the clinic and achieved proof-of-concept of ADXS-HPV in the indication of cervical cancer. Our mission is to continue to set the foundation to become the industry leader in immunotherapy drug development and HPV-associated cancer research. The nomination for Best Early-Stage Vaccine Biotech validates the company’s research and clinical development over the past year.”

The winner will be announced April 17, 2013, at the 6th annual ViE Awards Ceremony & Gala Dinner held in conjunction with the 13th Annual World Vaccines and Expo Conference to be held April 16-18 in Washington, DC.

For more information, please visit www.advaxis.com

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Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, today announced that Dr. Nicola Mason, lead investigator of the Penn canine study, and Dr. Yvonne Paterson, scientific founder of Advaxis, have been given the inaugural University of Pennsylvania One Health Award for their research of Advaxis’ proprietary immunotherapy, ADXS-cHER2, for the treatment of canine osteosarcoma.

The One Health Award, a new accolade for excellence in promoting One Health initiatives and inter-professional education, was established this year by the deans of the four health schools at Penn – Medicine, Nursing, Veterinary Medicine, and Dental Medicine. The award recognizes exemplary contributions toward expanding interdisciplinary education and improving health care.

“Dr. Paterson and I are delighted to have received the One Health Award for our work using ADXS-cHER2 to prevent metastatic disease in dogs with osteosarcoma. Phase 1 of this clinical trial is almost complete and we have been highly encouraged by the lack of adverse effects of this treatment,” stated Dr. Nicola Mason, Chair in Companion Animal Medicine at the University of Pennsylvania School of Veterinary Medicine. “It is too early to comment on the efficacy of the immunotherapy, however, we are encouraged by the data we have obtained so far and are optimistic that immunotherapies such as this one will provide safer and more effective treatment for dogs with cancer in the near future.”

ADXS-cHER2, under the direction of Dr. Nicola Mason, is being used to treat dogs suffering from bone cancer. In this trial, dogs that have undergone standard of care treatment for osteosarcoma; including limb amputation and follow up chemotherapy, and that overexpress the tumor marker HER-2/neu in their tumors, are treated with ADXS-cHER2. This immunotherapy is designed to stimulate the dog’s immune system to attack cancer cells that express the HER-2/neu marker. The goal is to elicit anti-tumor immunity and prolong survival.

Canine osteosarcoma is a leading killer of large breed dogs that causes tumors to form on long leg bones. The current standard of care is immediate amputation followed by chemotherapy; however, the cancer typically metastasizes, most commonly to the lungs, and causes death in 6-12 months in a percentage of afflicted dogs.

“The award winning research of Dr. Mason and Dr. Paterson establishes that the Advaxis platform technology can be extended to veterinary use,” commented Dr. Robert Petit, VP of Clinical Operations and Medical Affairs at Advaxis. “Data from this project will support the further development of our HER-2 targeted immunotherapy against HER-2 overexpressing malignancies in both veterinary and possibly human cancers.”

For more information on Advaxis, visit www.advaxis.com

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Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, provided a comprehensive business outlook for this year including its plans to advance its lead product candidate, ADXS-HPV, for the treatment of recurrent/refractory cervical cancer.

Based on establishing proof of concept in the Phase 2 clinical study being conducted in India in 110 patients with recurrent/refractory cervical cancer, Advaxis anticipates designing and preparing the launch of a Phase 3 registration program with ADXS-HPV, its proprietary immunotherapy product candidate for the treatment of cervical cancer. The company also announced that management is committed to continuing to strengthen its financial position, executing its strategic priorities, and achieving multiple clinical milestones for 2013.

Thomas A. Moore, Chairman and CEO of Advaxis, stated, “In 2012, we made significant advancements on multiple fronts, and now we see a clear path moving forward. Specifically, on the clinical front we are pleased with the progress of our ongoing Phase 2 clinical studies in recurrent/refractory cervical cancer. We have achieved proof of concept and continue to build a solid body of consistent and encouraging safety and efficacy data. We are now preparing to advance our proprietary lead product candidate, ADXS-HPV, towards a registration development program. We are confident that we will have a prominent position in this significant unmet medical need and we believe we will continue to build tremendous additional value in this program as we advance it towards registration and further dialogue with potential licensing partners.”

“We believe that with our progress with ADXS-HPV, the continued strengthening of our financial situation, the bolstering of our management team, and the significance of our near-term clinical milestones, Advaxis is fundamentally stronger today than ever before. We believe we have all of the key elements in place for a transformational 2013,” Moore added.

Daniel J. O’Connor, SVP and Chief Business Development and Legal Officer of Advaxis, commented, “The Company has never been more primed for a transformational year and I am convinced that we are poised for success. We remain committed to scientific excellence, strong operational execution, and are excited by the enormous potential of our proprietary technology platform.”

Advaxis a number of clinical milestones expected to be achieved over the next 12 months. To read the entire press release, visit http://www.irdirect.net/pr/release/id/133759

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Advaxis, Inc. (ADXS) Summaries Bright Outlook for 2013 with High Expectations

Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, provided a comprehensive business outlook for this year including its plans to advance its lead product candidate, ADXS-HPV, for the treatment of recurrent/refractory cervical cancer.

Based on establishing proof of concept in the Phase 2 clinical study being conducted in India in 110 patients with recurrent/refractory cervical cancer, Advaxis anticipates designing and preparing the launch of a Phase 3 registration program with ADXS-HPV, its proprietary immunotherapy product candidate for the treatment of cervical cancer. The company also announced that management is committed to continuing to strengthen its financial position, executing its strategic priorities, and achieving multiple clinical milestones for 2013.

Thomas A. Moore, Chairman and CEO of Advaxis, stated, “In 2012, we made significant advancements on multiple fronts, and now we see a clear path moving forward. Specifically, on the clinical front we are pleased with the progress of our ongoing Phase 2 clinical studies in recurrent/refractory cervical cancer. We have achieved proof of concept and continue to build a solid body of consistent and encouraging safety and efficacy data. We are now preparing to advance our proprietary lead product candidate, ADXS-HPV, towards a registration development program. We are confident that we will have a prominent position in this significant unmet medical need and we believe we will continue to build tremendous additional value in this program as we advance it towards registration and further dialogue with potential licensing partners.”

“We believe that with our progress with ADXS-HPV, the continued strengthening of our financial situation, the bolstering of our management team, and the significance of our near-term clinical milestones, Advaxis is fundamentally stronger today than ever before. We believe we have all of the key elements in place for a transformational 2013,” Moore added.

Daniel J. O’Connor, SVP and Chief Business Development and Legal Officer of Advaxis, commented, “The Company has never been more primed for a transformational year and I am convinced that we are poised for success. We remain committed to scientific excellence, strong operational execution, and are excited by the enormous potential of our proprietary technology platform.”

Advaxis a number of clinical milestones expected to be achieved over the next 12 months. To read the entire press release, visit http://www.irdirect.net/pr/release/id/133759

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Advaxis, a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases, this morning told investors that a conference call and live audio webcast has been scheduled for Wednesday, March 6, 2013. Starting at 5 p.m. ET, management will discuss the company’s 2013 business outlook, including progress with and plans for advancing its lead development program, expected clinical and corporate milestones for the year, and its momentum and continued plans for further strengthening its financial position.

The biotech will also provide an update on the timing of the data release from the second of three dose cohorts in Lm-LLO-E7-07, a randomized, single blind, placebo controlled Phase 2 dose escalation study assessing the safety and efficacy of ADXS-HPV for the treatment of cervical intraepithelial neoplasia (CIN) 2/3. In a prior release, Advaxis said it anticipated reporting this data earlier in the first quarter of 2013. However, data are still being collected and analyzed from some of the clinical trial sites, therefore the results from Cohort 2 will instead be announced early in the second quarter.

Those who wish to join the call should do so by dialing 800-688-0836 (U.S./Canada) or 617-614-4072 (international). When requested, interested parties should enter code 70014771. A live audio webcast can also be accessed via http://www.advaxis.com/news/events-presentations. An archived version will be available on the Web site for 30 days.

Investors can replay the call by telephone for seven days beginning at 8:00 p.m. ET on March 6, 2013. Access numbers for this replay are 888-286-8010 (U.S./Canada) and 617-801-6888 (international); participant code 55408167.

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Few things in medical history have been so frustrating as the seemingly endless war against cancer. Huge amounts of money, together with some of the best minds in the world, have been pitted against the disease (actually diseases, since there are many types of cancer with fundamentally different characteristics), and yet progress, though undeniable, has been maddeningly slow. Now, almost suddenly, there are serious indications that it’s a new ballgame, and that cancer has a rapidly dimming future.

Advaxis, a New Jersey based biotechnology company developing the latest drugs for various cancers and infectious diseases, is helping to lead the charge in what could become one of the biggest developments in modern medicine, immunotherapy. Unlike chemotherapy, which uses chemical poisons to kill cancer cells, poisons which are indiscriminate enough to kill many healthy cells as well, immunotherapy uses advanced biological technologies to manipulate the body’s natural immune system, making it able to both identify and attack cancer or other diseased cells with minimal damage to healthy cells.

It’s an exciting idea that has been around for a long time, but only now have the technologies developed to the point that proven drugs are starting to be released. It’s the first dribble in what could soon become a flood, as the various issues common to any new medical technology are finally worked out. The initial industry bumps in the road are rapidly being smoothed, and government approvals are finally being awarded. Why so long?

The answer is that, in order to attack cancer, it required a totally new in-depth understanding of, and ability to deal with, the internal workings of the human cell. Without this understanding, treatments could consist only of roughly tuned attacks on masses of cells that often resulted in the death of many healthy cells while many cancer cells remained alive to grow back later. This new understanding has taken decades of trial and error work to put together, time during which real treatments were not forthcoming. An entire industry of technologies had to first be developed to lay the foundation upon which modern therapies, like immunotherapy, are built. Now, at last, the final stages are being constructed, and new therapies are coming to the front. Work remains, but, thanks to companies like Advaxis, the long fight against cancer is finally turning.

For additional information, visit www.Advaxis.com

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Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) has been chosen to coordinate a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. Dr. Howard Safran, professor of medicine, will be principal investigator. Patients will be treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). Multiple institutions will collaborate.

This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response. The study is expected to open for enrollment February 2013.

“We are pleased that the Brown University Oncology Research Group is coordinating this study in anal cancer using Advaxis’ lead construct ADXS-HPV,” commented Dr. Robert Petit, Vice President of Clinical Operations & Medical Affairs at Advaxis. “This study is an important first step in evaluating the combination of ADXS-HPV immunotherapy with the standard of care in HPV-associated cancers like anal cancer. The investigation of ADXS-HPV across a number of indications and in combination with other therapies will help us learn how best to use Advaxis immunotherapy to benefit patients with HPV-associated cancers. The anal cancer study will continue to build the safety and efficacy profile of our immunotherapy platform.”

Virtually all cases of squamous cell cancer (SCC) of the anus are caused by a Human Papilloma Virus (HPV) infection. Anal cancer cells infected with HPV have the tumor associated antigen HPV E7. ADXS-HPV causes antigen presenting cells to stimulate other immune cells to attack cancer expressing HPV E7. In Phase 1 clinical trials and preliminary data from ongoing Phase 2 trials, ADXS-HPV has been safely administered to 193 patients with other HPV-associated diseases (recurrent/refractory cervical cancer and CIN 2/3), and it has demonstrated clinical benefit as a single agent or in combination with chemotherapy.

For additional information, visit www.Advaxis.com

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Advaxis, a biotech developing the next-generation of immunotherapies for cancer and infectious diseases, announced it will present at the 15th Annual BIO CEO & Investor Conference on February 11th at 9:30am EST in the Basildon room at the Waldorf-Astoria in New York City.

The company has more than fifteen distinct constructs in various stages of development, all of which are involved in strategic collaborations with recognized centers of excellence such as the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, and others.

Thomas Moore, Chairman and CEO of Advaxis, will provide additional information on its Phase 2 study of ADXS-HPV in recurrent/refractory cervical cancer in 110 patients in India. This important construct was recognized as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines.

In addition to providing ongoing social media coverage of the conference, MissionIR will issue a special broadcast to subscribers profiling companies scheduled to deliver a presentation. To sign up for The Mission Report, visit www.MissionIR.com.

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Advaxis, a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases, is developing a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to the cancer itself.

The company’s approach has been determined to outsmart tumor protection reactions that foil other treatments, while also generating a long-term immune system “memory” that is able to hunt down cancer cells throughout the body beyond the initially targeted antigens. And, being an immunotherapy, it does it all without the poisons and associated side effects of traditional chemotherapy treatments.

Advaxis immunotherapies are designed to stimulate many complementary immune mechanisms of action, including:

• Strong innate immune effects
• Strong adaptive immune effects
• Reduction of both Tregs and MDSCs in tumors but not in other tissues or systemically
• Memory generation that is not impaired by antibiotics administered immediately after dosing
• Chemotaxis and extravasation of activated immune cells
• Upregulation of tumor chemokines and chemokines receptors
• Epitope and antigen spreading
• A predominantly cellular immune response with little antibody formation

Over 15 distinct constructs are in various stages of development, either developed directly by Advaxis or through strategic collaborations with recognized centers of excellence, such as the National Cancer Institute. The company’s first construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials for HPV associated diseases (CIN 2/3, cervical cancer, and head & neck cancer). In addition, Advaxis has developed immunotherapies for prostate cancer and HER2 expressing cancers (such as breast, gastric, bladder, brain, pancreatic, ovarian cancer, and canine osteosarcoma).

For additional information, visit www.Advaxis.com

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Thomas A. Moore, the Chairman and CEO of Advaxis, a New Jersey based biotech
company focused on using bio-engineered bacteria to help the immune system fight
cancer and other diseases, recently gave a presentation at the 6th Annual
OneMedForum Conference, a platform for the newest ideas and companies in health
and medicine. The presentation provided an opportunity to summarize the goals,
unique strengths, and accomplishments of Advaxis as it helps lead what is
becoming a revolution in the treatment of cancer and infectious diseases.

Mr. Moore showed how Advaxis is an immunotherapy company that is
different in that, through use of a genetic immune response against a safe
version of a common pathogen, the company’s platform technology is designed
to:

• Drive a more comprehensive therapeutic response
• Overcome tumor
protection mechanisms at the tumor as in no other treatment
• Create “epitope
spreading” beyond targeted antigens, a sort of immune memory for long term
effects

Mr. Moore emphasized that this superior technology for fighting
cancer is a very well developed, with many peer reviewed papers and over 70
issued and pending patents. As an immunotherapy based therapy, it is not a
poison based approach such as chemotherapy, where healthy cells are killed in
attacking disease cells. It’s an approach that can work throughout all parts of
the body at the same time, since it is based upon the body’s own immune system.

The Advaxis approach leads to a 300% increase in killer T cells present
in the tumor, while simultaneously reducing by a full 80% the number of cells
around the tumor that tend to deactivate killer T cells. The approach also turns
the immune system on in such a way that it enables it to attack new targets.
Initial results are encouraging, with animal studies showing a 75% tumor
reduction. In addition, early safety studies on humans have shown no adverse
effects.

For additional information, visit www.Advaxis.com

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In its quest for new ways to use bio-engineered bacteria to manipulate the immune system as a superior tool for fighting cervical and other cancers as well as infectious diseases, Advaxis collaborates with top research centers around the world.

• National Cancer Institute – Advaxis works with the Institute’s Gynecologic Oncology Group to conduct a multi-center, Phase 2 clinical trial of ADXS-HPV immunotherapy, for patients with recurrent or refractory cervical cancer who have failed prior cytotoxic therapy.

• University of Pennsylvania – Advaxis works with the University’s School of Veterinary Medicine, collaborating with Dr. Nicola Mason to study the ADXS-HER2 construct for the treatment of canine osteosarcoma in large breed companion dogs.

• Cancer Research UK – The UK organization, dedicated to cancer research, is conducting a clinical trial to investigate the use of ADXS-HPV for the treatment of head and neck cancer.

• Montefiore Medical Center – Advaxis is working with Dr. Chandan Guha at the Albert Einstein College of Medicine and Montefiore Medical Center to develop the ADXS-PSA construct for the treatment of prostate cancer.

• National Cancer Institute – Advaxis has a Collaborative Research and Development Agreement (CRADA) with the Vaccine Section of the Institute for the development of Advaxis immunotherapies.

• Wistar Institute – Advaxis is collaborating with the Wistar Institute in Pennsylvania to explore the potential of FAP as a target for immune attack and as the basis for the development of an Advaxis immunotherapy.

• University of British Columbia – Advaxis is collaborating with the laboratory of Dr. Tobias Kollmann to develop Advaxis immunotherapies for the treatment of infectious disease and to develop new dosage forms.

• Karolinska Institutet – Advaxis is collaborating with the laboratory of Professor Marianne van Hage at the Karolinska Institutet in Stockholm, Sweden, to evaluate the potential of Advaxis immunotherapies to treat and prevent allergies in established scientific models of allergic diseases.

For additional information, visit www.Advaxis.com

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Although great strides have been made in the prevention and treatment of cervical cancer, there are still over 12,000 newly diagnosed cases in the U.S. every year. In addition, approximately ½ million patients every year are diagnosed with high grade cervical intraepithelial neoplasia (CIN 2/3), the predecessor condition to cervical cancer. Cervical cancer is associated with Human Papilloma Virus, a very common virus that can affect the cells of the cervix. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). In 2009, the CDC reported that about 45% of women aged 20 to 24 had HPV. HPV causes a number of other types of cancer as well. In developing countries around the world, the situation is even worse. In India, for example, over 72,000 women died of cervical cancer in 2008.

Advaxis is a biotechnology company developing therapeutic immunotherapies targeting HPV-associated diseases: cervical intraepithelial neoplasia (CIN 2/3), recurrent or refractory cervical cancer, as well as head and neck cancer. They have also developed immunotherapies for prostate cancer and HER2 expressing cancers (such as breast, gastric, bladder, brain, pancreatic, ovarian cancer, and canine osteosarcoma).

Advaxis immunotherapies are based on a unique platform technology that uses live, attenuated bacteria, bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the cancer itself. The company currently has more than fifteen constructs in various stages of development, either developed directly by Advaxis or through strategic collaborations with recognized centers of excellence, such as the National Cancer Institute, Cancer Research – UK, the Wistar Institute, and the University of Pennsylvania, among others. ADXS-HPV, the company’s first construct, is being evaluated in 4 Phase 2 clinical trials for HPV associated diseases (CIN 2/3, cervical cancer, and head and neck cancer).

For additional information, visit www.Advaxis.com

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The 1966 science fiction movie Fantastic Voyage tells the futuristic story of an attempt to save a man’s life by using a new miniaturization technology. In the movie, a specially designed submarine and crew are reduced in size to a microscopic dot, allowing scientists to inject them into the patient where they are able to destroy a blood clot and save the patient’s life. An incredible story, but one with parallels to the research and development being carried out by New Jersey based biotechnology company Advaxis.

Advaxis is developing ways to use tiny bio-engineered bacteria to manipulate the human immune system as a unique way of fighting cancer and infectious diseases, like training millions of micro-surgeons to operate deep inside the body. The company’s immunotherapy platform technology is based on the use live, attenuated bacteria, bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to attack the cancer itself.

Over 15 distinct constructs are in various stages of development, either developed directly by Advaxis or through collaboration with recognized centers of excellence around the country and the world. Advaxis’ first construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials for HPV associated diseases (CIN 2/3, cervical cancer, head and neck cancer). In 2012, Advaxis won an award for the Best Therapeutic Vaccine at the 5th Annual Vaccine Industry Excellence Awards in Washington, DC.

This week, Advaxis Chairman and CEO, Tom Moore, presented at the 6th Annual OneMedForum, a gathering of leading investors and management for some of the most promising emerging life science companies in Asia and North America, where he spoke about developing the next generation of cancer immunotherapies. It was an important opportunity to make the company’s case to investors, and it didn’t hurt that ADXS shares have recently jumped over 80% after getting coverage from the GotStockTips SMS alert service.

For additional information, visit www.Advaxis.com

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