Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘Infectious Diseases’ category

Today we take a short break from our AACR conference coverage and look at some creative new research that has its roots in oncology, i.e. antibody drug conjugates (ADCs), while being adapted and adopted for use in microbiology and infectious diseases.  Here at BSB, we have always been attracted to innovative science and technology and this latest project certainly fits that bill.

This is not such a stretch as many may think, after all, advanced cancer patients or those in an ICU  tend to be prone to infectious complications, which can, unfortunately, be lethal.

While this work is currently ongoing in the preclinical setting, it could be something we hear a lot more about in the near future as clinical development rolls out and there is a dramatic impact for patients.

Curious as to what all the fuss is about?

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The FDA earlier this week issued a safety alert to doctors that repackaged bevacizumab (Avastin®) had caused serious eye infections in 12 patients in Florida. The New York Times today reports that five patients at the Veterans Affairs Medical Center in Los Angeles have gone blind as a result of an eye infection following injection of compounded Avastin.

I have written previously about the Lucentis v Avastin debate and the results in the Comparison of Age-related macular degeneration treatment trial (CATT) published earlier this year in the New England Journal of Medicine.

It is not good news that contamination has occurred while compounding bevacizumab (Avastin) from sterile100mg/4mL single use preservative-free vials into individual 1mL syringes.

Genentech/Roche may see this news as reinforcing their position that ranibizumab (Lucentis®) should only be used, since it comes in the correct dose for injection in the eye. However, this ignores the reality caused by the fact that Lucentis is approximately 40x the cost of compounded Avastin ($1950 versus $50).

This week’s news does not support the proposition that intravitreal injection of bevacizumab is not safe and effective for the treatment of AMD, nor any suggestion that pharmacies properly accredited and experienced in aseptic techniques are not qualified to do this. Pharmacists compound drugs everyday.

As the FDA notes in their alert:

“Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.  Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.”

However, there is no evidence to suggest that the pharmacies who undertook the Avastin compounding that led to the infection were not “appropriate, reliable sources and properly administered.”

The New York Times notes that the the contaminated Avastin came from the pharmacy at the main campus of the V.A. Greater Los Angeles Healthcare System.  There is no mention of whether the VA pharmacists did the compounding themselves or sourced the drug elsewhere.

According to a news report in the Florida SunSentinel, the pharmacy identified as the source of the infection in Florida is InfuPharma. This is not a retail pharmacist in the high street, but a specialist compounding pharmacy that advertises sterile preparations for numerous products. Licensed pharmacists run this specialist company and looking at their website they do appear to be experienced in this area.

Endophthalmitis is a serious eye infection that may lead to loss of vision. The contamination should not have occurred.  These incidents should not, however, be blown out of proportion in the Lucentis v. Avastin debate.

Sadly, infections and contamination happen in hospitals and the healthcare industry all the time. Even the FDA approved manufacturing facilities of pharmaceutical companies have experienced problems in recent years.  Last summer, BMS experienced issues with sterile manufacturing standards at their Puerto Rico plant following FDA inspections.  Earlier this week, Baxter announced they had filed a lawsuit against Teva for indemnification over a hepatitis C outbreak following reuse of oversize propofol vials.

The news of serious eye infections with repackaged Avastin must, therefore, be put in context. There are countless patients around the world who have benefited from intravitreal injections of Avastin for treatment of their age-related macular degeneration (AMD). The issue raised by the infections in Florida and Los Angeles is whether there is adequate inspection and certification of compounding pharmacies, and whether there is a need for more State regulation and inspections in this area.

Disclosure:  I have written freelance articles for Pharmacy Today, the magazine of the American Pharmacists Association.

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Nanotechnology is leading to innovation in drug delivery, and new ways to treat diseases.

In an April 3, 2011 online article in Nature Chemistry, researchers from the IBM Almaden Research Center, Institute of Bioengineering and Nanotechnology in Singapore and Zhejiang University in China publish groundbreaking data on how biodegradable nanoparticles could be used to treat infectious diseases such as methillicin-resistant Staphylococcus aureus (MRSA).

The research shows how nanoparticles can selectively disrupt microbial cell membranes, walls and inhibit the growth of gram-positive bacteria, MRSA and fungi.

What makes this research exciting, is that the nanoparticles did not cause haemolysis or break-up of red blood cells.  The authors note that nanoparticles for the treatment of infectious diseases could be “synthesized in large quantities and at low cost” and are therefore “promising as anti-microbial drugs.”

The global market for infectious diseases was $90.4 billion in 2009 and is projected to reach $138 billion in 2014.  In the United States there are now more deaths from MRSA than there are from AIDS (18,650 MRSA deaths in 2005 compared to 16,000 for AIDS according to a paper in JAMA).

With more than 94,000 MRSA infections a year in the United States, and the increasing resistance of MRSA to existing anti-microbial therapies, treatment of infectious diseases is a major public health concern. Hospital acquired MRSA infections particularly target the elderly and those vulnerable through weakened immune systems.

Innovations in nanotechnology and drug delivery, such as the one published by Nederberg, Zhang, Tan & Xu in Nature Chemistry, open the door to potential new anti-microbial therapies.  It will be interesting to see how this research is commercialized and translated into new products and treatments.

ResearchBlogging.orgNederberg, F., Zhang, Y., Tan, J., Xu, K., Wang, H., Yang, C., Gao, S., Guo, X., Fukushima, K., Li, L., Hedrick, J., & Yang, Y. (2011). Biodegradable nanostructures with selective lysis of microbial membranes Nature Chemistry DOI: 10.1038/nchem.1012

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