Advaxis Awarded Best Therapeutic Vaccine at the 5th Annual Vaccine Industry Excellence Awards (ADXS)

Advaxis, Inc. (ADXS) is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that is designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

Advaxis was the recipient of the Novartis sponsored Best Therapeutic Vaccine Award at the 5th Annual Vaccine Industry Excellence Awards, which were "created to honor and generate recognition of the efforts, accomplishments, and positive contributions of companies and individuals in the vaccine industry."

Advaxis received the award due to "progress made to date through clinical trials and/or achieved milestones" and "advanced efficacy, safety, and risk management data where appropriate."

In February, Advaxis announced encouraging results from "the first of 3 dose cohorts in the single blind, placebo controlled Phase II dose escalation study assessing the safety and efficacy of ADXS-HPV in the treatment of cervical intraepithelial neoplasia (CIN) 2/3."

Below is a summary of the Cohort 1 results:

• "In the ADXS-HPV arm, 52% of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal.  This means surgery is longer be required.  The dose in cohort 1 is about 1/20th of the dose being used in trials of ADXS-HPV in cervical cancer.
• This 52% regression rate of ADXS-HPV with the lowest dose tested is very encouraging. According to the American Academy of Clinical Research’s Task Force on the Treatment and Prevention of Intraepithelial Neoplasia, 50% objective regression rate with a new treatment agent is considered clinically meaningful.
• Further, according to O’Shaughnessy, et al 2002, CCR, 8:314, “An improvement in CIN 2/3 to either pathologically normal cervix or of CIN 3 to CIN 1, with no new CIN 2/3 lesions appearing in at least 50% of the treated patients, is evidence of clinical benefit of the new agent.”
• In the cohort 1 trial, 40% of CIN 2/3 lesions spontaneously regressed in the placebo arm. This is within the range reported in the scientific literature of 35%-43% (Wright, et. al. 2003. Am J Obstet Gynecol, Am. J. Obstet. Gynecol. 289:295).
• ADXS-HPV is safe. Less than 1/3 (29%) of the patients treated reported any side effects associated with treatment. Those that occurred were mild and self-resolved or responded quickly to treatment.
• No SAEs (serious adverse events) were reported." Read more about the trial at Advantage.Numoda.com. 

Chairman & CEO of Advaxis Thomas A. Moore commented,

"We are delighted to receive recognition for our Company's achievements in developing ADXS-HPV. Our team continues to bring our proprietary platform technology from the laboratory into the clinic and meet major milestones in development in HPV caused cancers and soon in prostate and breast cancer, as well."

Read more at FierceVaccines.com. 

Bavarian Nordic's PROSTVAC® update & reception June 4, 2012 in Chicago

Bavarian Nordic's PROSTVAC® update & reception will be held in Chicago on Monday, June 4, 2012.

PROSTVAC® is a therapeutic vaccine currently enrolling in a pivotal Phase 3 trial (PROSPECT) of 1,200 patients with asymptomatic or minimally symptomatic castration-resistant prostate cancer that was initiated in November 2011 and is expected to form the basis for approval of the vaccine for this patient population. 

Pre-registration for the June 4 event is required and attendance is limited, so please click "Register Now!" to RSVP today.

Speakers at the event include:

• Dr. James L. Gulley (NCI)
• Dr. Philip W. Kantoff (Dana-Farber)
• Anders Hedegaard (Bavarian Nordic)
• Dr. Reiner Laus (Bavarian Nordic)

Contacts:

Mettes Buhls 

Bavarian Nordic 

mette.buhl@bavarian-nordic.com 

or

Michael Becker 

MD Becker Partners 

michael@mdbpartners.com 

Get more information

Prima BioMed Announces Changes to the Board and Senior Management $PBMD

Prima BioMed Ltd ("Prima" or the "Company")(PRR.AX) $PBMD advises of the following changes to senior management and the board of directors.

The Company's Chief Executive Officer, Martin Rogers, will step down effective 31 August 2012. Mr. Rogers will remain on Prima's board as a non-executive director from 1 September 2012.

Matthew Lehman, the Company's Chief Operating Officer, will assume the CEO role effective 1 September 2012. Mr. Lehman will join the Prima board of directors effective immediately. Mr. Lehman will be the Acting CEO during the period of Mr. Rogers' nuptial leave until the end of July 2012.

These changes are intended to facilitate CVac's continued clinical and regulatory development, and position Prima for the Company's next stage of growth.

Prima Chairman Lucy Turnbull AO said: "On behalf of the Company, we would like to thank Martin Rogers for his tireless work in transforming Prima over the past 4 1/2 years. Under his leadership, Martin consolidated Prima's research activities to focus on development of CVac, he brought together a strong management team and board of directors, and he has overseen the globalization of Prima's development activities with key operations in the USA and Germany. As Martin transitions out of active management, he leaves the Company in a strong financial position with significant opportunity for growth. On behalf of everyone at Prima, we thank Martin for his service and wish him well in his future endeavors."

Mr. Rogers said: "It has been an honor to serve patients, the medical community, and our shareholders over the past 4 1/2 years. I have every confidence that the Prima team is in an excellent position to capitalize on the success the Company has achieved to date, in both the clinical programs for CVac™ and at the corporate level. Prima has a world class management team and it has been a privilege to work with such a talented group. I would like to acknowledge the outstanding support of the board and all the Prima team during my tenure as CEO."

Ms. Turnbull continued: "We are confident that Matthew Lehman's extensive experience in product development and clinical trial execution will serve Prima well in the next stages of the Company's growth. After successfully leading Prima's operations and clinical development for over 2 years, he is a natural choice for this role."

As Mr. Lehman transitions into the CEO role, he will relocate from Germany to the San Francisco Bay Area, where Prima plans to concentrate its longer-term operational expansion.

On his appointment as an executive director and being named CEO designate, Mr. Lehman said: "It gives me great pleasure to join Prima's board and to be named CEO designate after having worked closely with our directors for the past several years. I would like to thank Martin for his support, and the enthusiasm and passion he brought to Prima. As the Company's next CEO, I look forward to working with the Prima management team and the board to build upon the strong foundation set by Martin."

Mr. Lehman continued: "I also look forward to spending significant time in Australia meeting with shareholders, while maintaining a strong link to the major US and European markets. As a truly global organization, we will have a good geographic representation among our board and our senior management."

Also effective today, Dr. Neil Frazer has stepped down from his position as an executive director on the board. This move assures consistency with the Corporate Governance Principles and Recommendations of the Australian Securities Exchange such that the independent non-executive directors maintain a majority on the Company board. The board thanks Neil for his outstanding contributions as a board member and looks forward to a continued strong working relationship in his senior management role as Chief Medical Officer.

The Company advises of further updates to senior management. Dr. Sharron Gargosky has been promoted to Chief Technical Officer. Dr. Gargosky, based on the West Coast of the US, is charged with leading the scientific and technical development of CVac globally. Marc Voigt has been promoted to General Manager of the German subsidiary and Chief Business Officer of the Company. Mr. Voigt will be globally responsible for coordinating investor relations and driving business development.

About Matthew Lehman
Mr. Lehman joined Prima as Chief Operating Officer on 1 February 2010. He has since played a leading role in the clinical development of CVac as well as the executive management of the Company.

Prior to joining Prima, Mr. Lehman was the Chief Operating Officer for SPRI Clinical Trials, an international contract research organization servicing the biotechnology and pharmaceutical industries, where he led successful expansion of the business in the emerging Eastern European markets. Over the years, Mr. Lehman has held various positions of increasing responsibility in clinical development and biotechnology operations, with extensive experience managing large teams across the United States and Europe. He has been involved in hundreds of R&D programs in oncology and other therapeutic areas, including key development contributions to a number of now FDA- and EMA-approved products. Mr. Lehman is active in a number of industry organizations with a strong interest in optimizing clinical research and efficient deployment of R&D expenditures.

Mr. Lehman earned a BA from the University of Louisville and an MS from Columbia University.

About Prima BioMed
Prima BioMed is a global biotechnology company headquartered in Australia. As a leader in personalized bio-therapeutic products for cancer, Prima is dedicated to leveraging its current technology and expertise to develop innovative treatment options for patients and maximize value to shareholders. Prima's lead product is CVac™, an autologous dendritic cell product currently in clinical trials for ovarian cancer.

Contacts
Australia Investor/Media:
Mr. James Moses
Mandate Corporate
+61 (0) 420 991 574
Email Contact

USA Investor/Media:
Ms. Kathy Galante
Burns McClellan Inc.
+1 (212) 213-0006
Email Contact

Europe Investor/Media:
Mr. Axel Mühlhaus
edicto GmbH
+49 (0) 69 905505-52
Email Contact

Few Doctors Prescribing Most Opioids @ The WSJ; $IPCI

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug. 

According to a recent article in the Wall Street Journal, "31% of the opioid prescriptions in [New York City in 2010] were written by about 530 health-care providers, or 1% of those who prescribe such drugs. Among these prescribers, oxycodone prescriptions skyrocketed 86% between 2008 and 2010. During the past 20 years there has been a ten-fold increase in the use of prescription opioids, commonly known by names such as OxyContin and Vicodin, in the five boroughs. Opioid prescriptions filled by city residents increased by 22%, to more than 2 million, in 2010 versus 2008, the data show."

While some of these prescriptions are being written by well-meaning but ill-informed practitioners, others are being issued by doctors intentionally engaging in wrongful behavior.

Deputy Mayor Linda Gibbs, co-chairwoman of the mayor's task force to combat the city's growing prescription drug epidemic, stated,

"In the face of growing opioid abuse, it is critical that we educate providers, pharmacists and patients on the potential dangers of painkiller misuse or overuse."

She continued,

"Strengthening our drug monitoring system will help us work together to both ensure that well-intentioned providers don't inadvertently overprescribe these pills—with potentially dangerous consequences—and that we have the information we need to investigate those who are actively engaging in criminal behavior." Read more at online.wsj.com. 

While it is indeed important to monitor how addictive painkillers are being prescribed, it is also important to pursue new treatments that do not pose the same risks. Intellipharmaceutics' Rexista™, now in pre-clinical development, is one such alternative. Rexista™ is an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. This product is covered by pending patent applications. Rexista™ is a unique dosage form, designed to be resistant to well-documented abuse that is experienced with current oxycodone products. This includes abuse by injection when combined with solvents and by nasal inhalation when crushed or powdered.

Rexista™ is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs, such as hydromorphone. According to Wolters Kluwer Health, OxyContin® (oxycodone hydrochloride controlled-release tablets) had estimated U.S. sales of approximately US$2.5 billion for the 12 months ending February 2012. OxyContin® currently represents 99% of the US$3 billion oxycodone sustained-release market. Read more about Rexista™ at intellipharmaceutics.com. 

Medgenics Moving In Record Time @ Seeking Alpha (MDGN)

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) is a clinical-stage biopharmaceutical company developing an innovative and proprietary platform technology - a biological "Biopump" - which allows patients to produce, within their bodies and on a long-term basis, their own natural human protein therapy for the treatment of a range of chronic diseases, such as anemia and hepatitis C.

At Seeking Alpha, contributor Ray Dirks wrote an article highlighting the Medgenics' recent news that "the FDA approved its filing to start clinical trials using its Biopump platform technology to treat anemia in kidney dialysis patients" in record time.

He writes, 

"As we've said in the past, EPODURE, one of MDGN's three proprietary Biopumps in development, looks to eliminate frequent, costly and inconvenient injections of erythropoietin (EPO). Amgen Inc. (AMGN) has owned this space for years and medicine is ready for a change.

Our FDA, known for its sluggishness and bad management, moved quickly to allow Medgenics to commence Phase IIb trials in the US, giving us their endorsement of a valuable technology that even the agency can't ignore. EPODURE works, and the FDA recognizes that our overburdened healthcare system can only benefit from the economics that Medgenics offers."

He continues,

"When MDGN announces the enrollment of its first subjects, we expect a leap in MDGN shares. The kidney dialysis market is more than 100,000 people start dialysis each year in the U.S., and last year there were 500,000 patients receiving dialysis, an estimated industry of $42.5 billion...

With more therapeutic areas targeted, a better platform technology, and progress achieved faster than we've seen with other biopharmaceuticals, do not miss out on this time to buy."

Read more at Seeking Alpha. 

Pluristem's CEO Letter to Shareholders (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

Pluristem Chairman and CEO Zami Aberman released a letter to shareholders providing updates on the company's recent achievements, clinical and pre-clinical activities and their potential ramifications, as well as a finance update.

He writes,

"The past few months have been both busy and exciting for Pluristem. We have made great strides towards executing our strategy of developing a patient friendly, minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our whole team was moved and proud of the remarkable recovery of the seven year old girl we recently treated in a compassion treatment with our PLX cells. I believe that this case reminds us all that our first and primary goal is to help save the lives of patients."

Read the full letter at Pluristem.com.

NeoStem, Buying a falling knife, dead money of an atrophying model @ Scimitar Equity Blog (NBS)

NeoStem, Inc. (Amex: NBS) is a leader in the development and manufacture of cellular therapies. NeoStem has a  strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company.

At Scimitar Equity Blog, Founder and Director of Research Henry McCusker wrote an article discussing his concerns about NeoStem's financial state. He references a recent NeoStem announcement, which stated that "as of 3/31/12, between its US and China operations consolidated cash and cash equivalents of $21.8M, and an additional $2.5M in cash held in escrow." He then poses the question: "Are they TRUE and legal statements or is 'management fiddling as NBS burns'?

He continues,

"What is the true or real US cash position…in my additions and subtractions and rate of spending (using the KISS principle) NBS (approximating) had Plus (+) or minus (-) $1M in cash pre the recent $6.8M raise through Maxim. If NBS is spending $5M a quarter with April and May gone by, I would project a range of $3-4M as a current balance and NBS should be out of money by July end. Are the Erye pre-sale announcements a desperate 'screen' to prolong a further decline in the share pricing, or are they waiting for a 'miracle'?"

Read more at ScimitarEquity.com. 

Keryx Biopharmaceuticals Announces Upcoming Poster Presentation of Zerenex™ (ferric citrate) at the 49th ERA-EDTA Congress (KERX)

Keryx Biopharmaceuticals (KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

The Company announced that one of its abstracts has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France. The abstract is entitled "A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534);" it highlights the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex" (ferric citrate). 

The poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time.

The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf. Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

Read more at Seeking Alpha.