Novavax, Inc. (Nasdaq: NVAX) announced final selection of a Respiratory Syncytial Virus (RSV) vaccine candidate that will be advanced into additional preclinical studies to support an Investigational New Drug (IND) application. As previously announced, Novavax has been evaluating a number of RSV vaccine candidates, all of which have successfully induced antibody responses in mice. Novavax scientists have now engineered a new vaccine candidate which has been shown to protect mice against RSV disease and can be produced at sufficient yields to allow commercial manufacture. This new candidate is directed against a protein on the surface of the virus, the “F” or “fusion” protein, which is the protein that the virus uses to infect and fuse with cells in the respiratory tract and cause disease.

The new RSV-F vaccine candidate consists of novel three-dimensional particles containing the F protein. The structure of the F protein in these particles is identical to the configuration in which it exists on the surface of the native virus. The particle nature of the vaccine holds the promise for inducing a broad set of immune responses including antibody and cell mediated immune responses to prevent infection of the respiratory tract and attack respiratory cells that may already be infected with RSV.

The first preclinical study of this new vaccine candidate in mice showed that it induced production of antibodies that neutralized live RSV. In addition, the vaccine protected mice against replication of RSV in the lungs. The study included groups of mice that received two injections of RSV-F vaccine at doses of 1, 10, or 30 micrograms with and without adjuvant. The study showed that the RSV-F vaccine induced neutralizing antibody responses at all doses evaluated. The highest titers were observed with vaccine formulations that contained an aluminum-based adjuvant. Following vaccination, mice were exposed to live RSV through the nose. Even without adjuvant, the lowest dose (1.0 mcg) of RSV-F vaccine prevented RSV infection in the lungs of these mice. However, protection from RSV infection was not observed in unvaccinated mice. Based on these favorable pre-clinical data obtained with this RSV-F vaccine candidate and the ability to produce it at commercial yields, the Company has selected it for advanced preclinical development.

Today, the only therapy against RSV disease is a monoclonal F antibody. The antibody reduces RSV-related hospitalizations in infants and young children at high risk of severe disease. However, several injections are required and the lifespan of the antibody in the body has a limited duration. Therefore, a vaccine that induces long lasting protection against RSV-F would be highly desired by healthcare providers. There is currently no approved vaccine for the prevention of RSV and the market potential for such a vaccine could exceed $1 billion annually.

Dr. Penny Heaton, Chief Medical Officer and Vice President of Development at Novavax, stated: “A vaccine against the RSV-F protein is an ideal candidate to progress into advanced preclinical testing. Studies of the monoclonal RSV-F antibody show it protects against hospitalizations for severe RSV disease, suggesting that a vaccine which induces neutralizing antibody against RSV-F has the potential to be a powerful weapon against this disease.”

ABOUT RESPIRATORY SYNCYTIAL VIRUS

RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young children. Repeated infections occur throughout life causing moderate to severe cold-like symptoms. More severe lower respiratory tract disease is also seen in elderly adults over age 65 years similar to the severe illness witnessed in children. It is estimated that RSV infects more than 8.5 million adults annually, including the elderly over age 65 years. This virus is responsible for approximately 900,000 hospitalizations annually in the United States and major European countries. In the United States alone, RSV leads to 177,500 hospitalizations in high risk adults resulting in annual medicals costs exceeding $1 billion.

ABOUT NOVAVAX

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches.

Forward Looking Statement

Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to the early stage of Novavax’s product candidates under development; current results may not be predictive of future results; further testing is required before an IND may be filed with the FDA and human clinical trials can begin; uncertainties relating to clinical trials; results in human clinical trials may not be consistent with animal study results; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further preclinical work and clinical trials.

Source: Novavax, Inc

Cardica, Inc. (Nasdaq: CRDC) announced that the full results of the PAS-Port system multi-center pivotal trial, known as the EPIC trial, were published in the July issue of the peer-reviewed publication The Journal of Thoracic and Cardiovascular Surgery. The PAS-Port system, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in September 2008, creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during coronary artery bypass grafting (CABG) procedures.

“The data published this month confirm that the PAS-Port system produces comparable patency, saves approximately five minutes per connection and eliminates the need to clamp the aorta required for hand-sewn connections,” commented John D. Puskas, M.D., chief of cardiac surgery at Emory Crawford Long Hospital in Atlanta and principal investigator of the EPIC trial. “Overall, Cardica’s PAS-Port system provides a safe and reliable alternative to hand-sewing vessels during CABG procedures.”

Cardica conducted the 220-patient pivotal, prospective, randomized trial at 12 sites in the United States and Europe. In the trial, two venous bypass grafts were randomly selected in each patient to be connected to the aorta. The PAS-Port system was used for one graft and the conventional hand-sewn technique for the other, for a total of 440 randomized grafts. Patients were scheduled to receive a follow-up angiogram nine months after their index procedure to determine patency (or degree of openness of the vein graft) for both the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms.

The data published show that the PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major adverse cardiac events (MACEs) reported that may possibly be related to target vessel revascularization, four (33%) may have been related to the PAS-Port system with eight (67%) potentially related to hand-sewn anastomoses. During the trial, four patients had a stroke. In all cases of stroke, an aortic clamp was used for construction of a hand-sewn anastomosis. The study also demonstrated that the PAS-Port system saves approximately five minutes of operating room time when compared to both side-biting and facilitating hand-sewn anastomoses.

“Used in the United States, Japan and Europe during thousands of CABG procedures to date, the PAS-Port system allows surgeons to perform rapid, safe and effective automated anastomoses either on- or off-pump, with very little manipulation of the aorta,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. “Importantly, during the trial there were four cases of stroke, all of which occurred in patients where the aorta was clamped for hand-sewn anastomoses. By eliminating the need to clamp the aorta, we believe the PAS-Port system offers a significant benefit to bypass patients with no increased risk.”

The PAS-Port Proximal Anastomosis System Advantage

The innovative design of the PAS-Port system allows a surgeon to load the bypass graft into the system and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass graft vessel or the aorta. As of March 31, 2009, almost 14,000 PAS-Port systems had been sold in the United States, Japan and Europe, and according to Cardica’s distributor, today this product is used in more than 20 percent of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.

About Cardica

Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica’s products provide cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure. Cardica’s C-Port(R) Distal Anastomosis Systems are marketed in the United States and Europe and its PAS-Port(R) Proximal Anastomosis System is marketed in the United States, Europe and Japan.

Forward-Looking Statements

This press release contains “forward-looking statements,” including, without limitation, statements related to Cardica’s therapeutic and commercial potential for its PAS-Port Proximal Anastomosis System. The words “may,” “believe” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Cardica’s results to differ materially from those indicated by these forward-looking statements, including, without limitation, that Cardica’s current and any future products may never gain any significant degree of market acceptance, that any future Cardica products face regulatory, reimbursement and manufacturing risks, that Cardica’s intellectual property rights may not provide adequate protection and that Cardica will need substantial additional funding and may be unable to raise capital when needed, which would force Cardica to delay, reduce or eliminate its research and development programs or commercialization efforts, as well as other risks detailed from time to time in Cardica’s reports filed with the SEC, including its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Source: Cardica, Inc.

Chinese patients will soon have the opportunity to take part in a study of a novel therapy aimed at reversing the autoimmune disease, ankylosing spondylitis. Approximately 200 patients will be chosen to participate in a clinical trial that aims to merge the latest molecular discoveries published by the California non-profit Autoimmunity Research Foundation (ARF) with the medical expertise of physicians and researchers at West China Hospital.

Located at Sichuan University, West China Hospital is the largest clinical center in the world, with 4600 beds and 2.5 million outpatients per year. It is also is the Chinese center for the worldwide Cochrane Collaboration in evidence-based medicine.

The treatment protocol is based on a molecular understanding of the interaction of intracellular and biofilm bacteria with the operation and control of the body’s nuclear receptors. Dysregulation of these receptors has been shown to promote the systemic inflammation, immunosuppression, and hormonal imbalances characteristic of chronic disease.

The NIH Human Microbiome Project now estimates that approximately 90% of cells in the human body are bacterial or otherwise non-human in origin. Yet it has only been over the past decade that advanced DNA bacterial identification tools have begun to reveal the true impact of these microbes, many of which have yet to be characterized and identified. Estimated to number in the billions, the accumulation of different species of pathogenic bacteria has been implicated in dozens of chronic disease states. ARF has discovered how to restore nuclear receptor homeostasis so that the body’s own immune system can fight these pathogenic bacteria.

The East-West partnership, which will eventually include subjects suffering from other chronic diseases, will serve as a better-controlled and more formalized version of a trial that the Autoimmunity Research Foundation has been conducting over the past several years. These trials are aimed at moving the molecular discovery known as the Marshall Protocol as quickly as possible from bench to bedside.

Data from the initial ARF trial has been presented at conferences around the world from Karolinska, Sweden to Beijing, China. Detailed data showing that a majority of participants experienced symptomatic resolution or disease reversal from 20 autoimmune diagnoses, ranging from lupus to arthritis to thyroiditis was presented by Captain Tom Perez at the 2008 International Congress on Autoimmunity in Portugal.

“As a physician who has seen hundreds of patients respond positively to the therapy that will be tested at WCH I think data collected from the upcoming trial may very well be groundbreaking,” states Dr. Greg Blaney of Vancouver, Canada.

The collaboration is scheduled to begin at the end of August when researchers from ARF will travel to China to work with the WCH staff getting the study underway.

Both groups will also join together in applying for research grants from both public sources and private donors to ensure that the maximum possible number of participants with a wide range of diseases is eventually able to participate.

Source:
Paul Albert

Autoimmunity Research Foundation