Posted by Jessica Rayhill on Tue, May 01, 2012 @ 05:45 AM
Coridon Pty Ltd founded by Ian Frazer is aggressively working to develop the next generation of vaccines. Recently one of their investor companies, Allied Healthcare, has released a statement that provides a brief overview of Coridon's latest work, their newly acquired license with Nature Technology Corporation, and their contract with VGXI, Inc. to produce material for their Phase I clinical study.
The study will involve "Coridon's Herpes vaccine which was recently announced to be 100% effective in protecting animals against Herpes Simplex Virus 2 infection." This Phase I clinical study is scheduled to begin later this year.
To read the full press release please click here.
Posted by Jessica Rayhill on Mon, Apr 30, 2012 @ 03:00 PM
VGXI will be attending the 15th Annual NFID Conference on Vaccine Research from May 6 - 9, 2012.
Conference Description:
" The Annual Conference on Vaccine Research provides high-quality, current reports of scientific progress featured in both invited presentations and submitted oral abstracts and posters. As the premier venue for cutting edge learning, effective data sharing, and scientific collaboration on issues related to vaccines and immunization, the conference features international experts leading symposia and panel discussions.
The conference is designed specifically for epidemiologists; immunologists; microbiologists; molecular biologists; nurses; nurse practitioners; pharmacologists; pharmacists; physicians; post-graduate fellows; public health officials; researchers and scientists; vaccine, diagnostic, and device manufacturers; and veterinarians.
Conference Learning Objectives:
At the conclusion of the conference, participants should be able to:
- Discuss recent scientific advances that are contributing to the progress of vaccine development
- Identify research opportunities and scientific challenges associated with vaccine development, production, and distribution."
Helpful Links:
If you'd like to join VGXI at another conference this year please check out our
2012 Conference Schedule.
Then join our Linkedin DNA Vaccines Group and let us know that you'll be there!
Posted by Jessica Rayhill on Tue, Apr 17, 2012 @ 05:45 AM
According to Nanowerk News, "Delivering drugs and therapies selectively so they affect cancer cells but not healthy cells nearby is a major obstacle in drug delivery." Recently, researchers at Rice University, the University of Texas MD Anderson Cancer Center, and Baylor College of Medicine (BCM), have developed a new method to inject drugs directly into cancer cells using nanobubbles.
Nanobubbles are generated when a short burst of laser light strikes a plasmon, which is a wave of electrons that move back and forth across the surface of a metal nanoparticle. By matching the wavelength of the laser to that of the plasmon, and dialing in just the right amount of laser energy, Rice's Dmitri Lapotko's team can ensure that nanobubbles form only around clusters of nanoparticles in cancer cells, leaving healthy cells virtually unharmed. In their recent studies, using nanobubbles to deliver chemotherapy drugs was up to 30 times more deadly to cancer cells than traditional drug treatment and required less than one-tenth the clinical dose.
" By avoiding healthy cells and delivering the drugs directly inside cancer cells, we can simultaneously increase drug efficacy while lowering the dosage," said Lapotko.
These nanobubbles are tiny pockets of air and water vapor that form just below the surface of cancer cells and as the bubbles expand and burst, they briefly open small holes in the surface of the cells. These small openings allow the cancer drugs to rush inside. This same technique can be used to deliver gene therapy directly into cells as well.
"The nanobubble injection mechanism is an entirely new approach for drug and gene delivery, " said Dr. Malcolm Brenner, professor of medicine and of pediatrics at BCM and director of BCM's Center for Cell and Gene Therapy."It holds great promise for selectively targeting cancer cells that are mixed with healthy cells in the same culture."
Posted by Jessica Rayhill on Wed, Apr 11, 2012 @ 06:15 AM
Houston currently supports over 140 life science companies and is a place where biotechnology is continuing to grow and prosper. Employing around 75,000 life science workers, Houston as a leader in the industry comes as no surprise.
Houston leads in 5 areas of research:
- Cardiovascular Medicine
- Genomics and bioinformatics
- Infectious diseases and biodefense
- Oncology
- Nanotechnology
While most of the industry's focus is centered in the Texas Medical Center, the industry is expanding outside of Houston to the surrounding suburban areas. VGXI, a GMP plasmid manufacturer for example, is located in The Woodlands, Texas about 35 miles outside of Houston. To learn more about the Texas Medical Center please click here.
As Houston continues to grow, "The city has long attracted scientists for training who then decide to stay", says Richard Willson, Ph.D., professor of chemical engineering, biology, biochemistry, and biomedical engineering at the University of Houston and founder of a number of biotechs. In relation to other biotech hubs, " Houston is a good place to live; [and] the cost of living is one-third of that in San Diego". Houston is even able to capture more than $1.8 billion annually in support for academic research and development for institutions such as:
As John Mendelsohn, M.D. and president of The University of Texas M.D. Anderson Cancer Center states, "As our regional biotechnology industry develops it will drive growth in many other economic sectors: law, finance, design, construction, consulting and housing, among others. In the past 100 years, the Houston economy has repeatedly reinvented itself to answer the needs of one emerging industry after another - cotton, oil, energy, and medicine are examples. These transitions have not been easy, but each new industry has generated tremendous economic development in Houston. The biotech revolution will do the same, and I look forward to helping accelerate its growth."
Sources:
If you're interested in learning more about VGXI and our plasmid manufacturing capabilities please click here.
Posted by Jessica Rayhill on Wed, Mar 28, 2012 @ 05:45 AM
Do you need plasmid for your next gene therapy clinical trial?
Click below to find out how we can help.
Posted by Jessica Rayhill on Tue, Mar 13, 2012 @ 10:01 AM
"cGMPs" or "current good manufacturing practices" are guidelines that outline the aspects of production and testing that can impact the quality of a drug product. These general principles must be observed during drug product manufacturing.
GMP guidelines include all aspects of production; from the starting materials, the facility, equipment, and training of personnel. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems in place to provide documented evidence that correct procedures are consistently followed at each step in the manufacturing process. It is the company's responsibility to determine the most effective and efficient quality process.
The ultimate goals are to safeguard the health of the patient as well as producing good quality medicine, medical devices, or active pharmaceutical products.
These guidelines are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Why Do We Comply?
If cGMP guidelines are not followed, serious risks can be incurred for the patient and the company such as:
- Unexpected contamination of products which could cause damage to the patient's health or even death.
- Incorrect labels on containers can result in patients receiving the wrong medicine.
- Insufficient or excess quantities of an active ingredient can result in ineffective treatment or adverse effects.
- Countries not accepting the product and decreasing the exporting country's drug product sales due to not complying with cGMP guidelines. Many countries have created their own cGMP guidelines that correspond with their legislation which can create difficulty for manufacturers. VGXI, Inc. is fully cGMP compliant and has produced products for numerous DNA vaccine and gene therapy trials in the USA, Europe, Asia, and Australia.
Regulatory agencies are authorized to conduct unannounced inspections, though some are scheduled. In the United States the FDA is responsible for the enforcement of GMPs.
Learn More
- MHRA - The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
- EC Public Health - European Commission
- WHO - The World Health Organization version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world.
- FDA - US Food and Drug Administration
Posted by Jessica Rayhill on Fri, Mar 02, 2012 @ 05:45 AM
DNA vaccines are third generation vaccines, made up of small, circular pieces of bacterial DNA, plasmids. These plasmids are genetically engineered to produce specific antigens from a pathogen.
The DNA is injected into the cells of the body where the host cell then interprets the DNA and uses it to synthesize the pathogen's proteins. An immune response is then triggered when the pathogen's proteins are recognized as foreign to the immune system.
Some DNA vaccines were developed from “failed” gene therapy experiments. For example, the first demonstration of a plasmid-induced immune response was when mice injected with a plasmid expressing human growth hormone elicited antibodies instead of showing growth alteration.
What are the Advantages?
DNA vaccines have a number of advantages over conventional vaccines, including the ability to induce a wider range of immune response types and more:
- DNA vaccines are effective in stimulating antibody responses to attack infectious diseases as they enter the body, before they can infect cells, therefore acting as a preventive vaccine.[1]
- DNA vaccines are efficient at generating T-cell responses that may kill targeted cancerous cells or cells infected by the targeted virus or bacteria. DNA vaccines may therefore also be used as a therapeutic to treat existing disease. This capability provides the potential to treat chronic infectious diseases such as HIV and hepatitis C virus, as well as the possibility to develop therapeutic cancer vaccines.[1]
- DNA vaccine technology provides the opportunity to design sophisticated, multi-antigen vaccines and/or vaccines based on conserved genes and antigens that are common to evolved strains of a pathogen, e.g. the potential exists to develop a universal influenza vaccine to protect against both seasonal influenza strains as well as new influenza strains that cannot be known in advance and which present pandemic risk, such as new strains of avian influenza or the Mexican H1N1 influenza.[1]
- DNA sequences from multiple strains of a virus like influenza can also be designed in a "consensus" form where one antigen is able to confer protection against any one of the original viral strains.[1]
- DNA vaccines can potentially be developed from concept to FDA approval in eight to 10 years, rather than as much as 20 years that it took to develop, for example, the chickenpox vaccine.[1]
- They can be readily and cost effectively manufactured using off-the-shelf, well-proven fermentation technology.[1]
Want to join us on our DNA Vaccines group on Linkedin? Click here!
What are the Disadvantages?
One of the issues of most concern to researchers is the possibility that the injected DNA will actually integrate into one of the human chromosomes inside the cell. The effect could range from no effect or could potentially lead to cancer through alteration of normal DNA. Other disadvantages to DNA vaccines include:
- Limited to protein immunogens.[2]
- Risk of affecting genes controlling cell growth.[2]
- Possibility of inducing antibody production against DNA.[2]
- Possibility of tolerance to the antigen (protein) produced.[2]
- Potential for atypical processing of bacterial and parasite proteins.[2]
Current DNA vaccines
Currently only two DNA vaccines (i.e., Apex–IHN and Oncept) and one DNA therapy (i.e., LifeTide) are currently on the market, all for veterinary applications. Despite this slow start, DNA vaccine research is progressing steadily, and the approval of a human DNA vaccine in the next few years would be a groundbreaking achievement for the sector.
[1] Information provided by Inovio Pharmaceuticals
[2] Information provided by Harriet L Robinson and Tamera M Pertmer
Posted by Jessica Rayhill on Thu, Feb 23, 2012 @ 06:00 AM
A recent clinical trial performed by U.S. scientists proves that the "futuristic idea that microchips could be implanted under a patient's skin to control the release of drugs has taken another step forward."
The Details
The microchip, along with several (dependent on the number of doses needed) small, individually sealed wells of drug product, is packaged into a device that is similar to the size of a pacemaker and made out of biocompatible materials . "The whole device is approximately 3cm by 5cm, and 1cm thick," explained Dr. Robert Farra. This device started as a research project at Massachusetts Institute of Technology (MIT) but is now being developed by a company, MicroCHIPS Inc.
To read more from MIT, please click here.
How it Works
Inside the device, the drug wells are capped by a thin membrane of platinum and titanium. A dose is only released when that cap is broken by a small electrical current. The chip is programmed to control the timing of each dose, which allows them to be scheduled in advance and delivered on-time.
The device also holds the capability to be remotely controlled. In cases such as pain management medicine delivery, etc. the device can by controlled through a remote producing a radio signal. "When the microprocessor decides to pass the current through a particular membrane, the membrane decomposes in about 25 microseconds," states Prof Michael Cima. "The drug is then available for pick up in the capillaries that surround the device to go into the bloodstream."
To listen to Robert Farra describe how the device works in the body, click here.
Solving Problems - One Microchip at a Time
A nurse, Julie Thomson of the UK's National Osteoporosis Society, said that "such innovations could improve compliance among patients, some whom will stop injecting themselves [with their needed medication] because of the hassle." These automated drug delivery systems are likely to prove popular for patients who currently have a daily regimen of self-administered injections. Possible uses for the device include DNA vaccine delivery, cancer treatments, pain management, gene therapy treatment and more.
The Clinical Trail
The most recent clinical trial was conducted by U.S. scientists who used the device to deliver human parathyroid hormone fragment [hPTH(1-34)] for the treatment of osteoporosis. The device was inserted into the waists of each of the 8 women involved in the trial and activated using a remote control. The clinical trial reported the chip showed the correct doses could be administered and that there were no serious side effects using the device. Though this trial is known as the first in-human testing of a wirelessly controlled drug delivery microchip, this technology has been in development for more than 15 years.
What's Next?
MicroCHIPS, Inc. believes that these drug devices could eventually contain hundreds of drug wells and researchers from MIT believe the devices could be combined with chips that hold reservoirs of different kinds of drugs, and create a system which could adapt treatments in response to changing conditions in a patient's body.
Posted by Jessica Rayhill on Wed, Feb 15, 2012 @ 05:45 AM
Cystic Fibrosis
In the U.S. around 30,000 patients suffer from cystic fibrosis, a genetic disorder that causes the body to produce an unusually thick and sticky mucus that clogs the lungs, obstructs the pancreas, and stops enzymes from helping the body break down and absorb food. Patients are also prone to infections and progressively lose the ability to breathe. Until recently, patients have only been able to take medications that tackle the symptoms of the disease, not the cause.
Researchers discovered the genetic defect that causes CF in 1989 and believed this would lead to big breakthroughs. Unfortunately, these breakthroughs have occurred slowly, if at all. Attempts to "fix" this broken gene with gene therapy have been ineffective and left patients with little more than drugs that thin out mucus that has built up in their lungs.
Drug Approval
Today the drug Ivacaftor brand named Kalydeco from Vertex Pharmaceuticals Inc., has been approved by the FDA for the treatment of patients who have a mutation in a gene that causes CF in about 4% or 1,200 patients in the U.S. The genetic mutation, G551D is in a gene called the cystic fibrosis transmembrane conductance regulator, which regulates the transport of chloride and water in the body. The new drug helps the protein made by the CFTR gene function better, which improves lung function and improves other sides effects of cystic fibrosis.
Cost Worth The Value?
The pill which will cost around $294,000 a year will be among the most expensive therapies currently on the market. Jeff Leiden, Vertex's chief executive, said "the pricing reflects the value the drug provides, the small number of patients indicated for it and the company's hefty investment in developing cystic fibrosis treatments. It is hard to make these drugs, it takes hundreds of people working over a number of years and hundreds of millions of dollars, and it's all at risk." Though the cost is hefty, Vertex plans to provide some financial assistance to patients and assign a case manager to each patient to help guide them through any financial issues.
What do you think about the cost of this product, and other high priced drugs that patients are dependent on to live?
What's Next?
The drug is currently approved for patients six years old and older, Vertex is currently planning a study of the drug in patients between two and five years old. Researchers have also started testing combining Kalydeco with another drug that targets a much more common defect and hopes the two-drug combination will help perhaps 90 percent of patients.
With any luck, this drug will be only the first of several new CF drugs designed to counter a different fundamental cause of the condition.
What other diseases or illnesses would you like to see more personalized medicine occurring?
Meet Tori
"Tori is one of 30,000 children and adults in the United States who have Cystic Fibrosis, a life-threatening genetic disease that causes mucus to build up and clog some of the organs in the body, particularly the lungs and pancreas.
She has been receiving care at the Monroe Carell Jr. Children's Hospital at Vanderbilt since she was diagnosed in December 2009.
Tori's pediatrician, Frank Haraf, M.D., referred the Churches to Children's Hospital after Tori began having unusual bowel movements. A sweat test confirmed that Tori had Cystic Fibrosis, and she began to be cared for by Elizabeth Perkett, M.D., professor of Pediatrics in the Division of Pediatric Allergy, Immunology, and Pulmonary Medicine.
"We were shocked," said Natalie Church, Tori's mother. "The only thing I knew about CF was that I knew a girl that had lost her life from it a few years ago."
Tori began a rigorous treatment schedule at home, including three daily breathing treatments, and a therapy called chest percussions that her mother performs on her twice a day. She also takes 15 pills and uses an inhaler twice a day.
"Her treatments go by pretty fast," Church said. "She is doing so well now that she can swallow all her pills without even drinking anything. She's been really great about it."
Tori is physically able to do anything she wants. Her favorite activities are playing outside, swimming and playing with her friends and 1 year old brother, and of course, all things Disney. She and her family have been to Disney World several times."
Posted by Jessica Rayhill on Wed, Feb 01, 2012 @ 05:35 AM
VGXI will be attending several DNA Vaccine, Gene Therapy, and Biotechnology conferences in 2012 and we'd like to meet and get to know you. Here are the events we are attending:
VGXI is a contract manufacturing organization that specializes in the production of DNA plasmids under GMP. Let us know if you'd be interested in meeting us and finding out more about our Research Grade Plasmid Production, Pre-Clinical Plasmid Production, and our GMP Plasmid Production. To contact us please click here.