European authorities approve Prepandrix™, a pre-pandemic vaccine for Avian Influenza virus

01 June 2008

On May 19, 2008 GlaxoSmithKline announced that the European Medicines Agency (EMEA) has granted a marketing authorization in all 27 Europe member states for Prepandrix™, a pre-pandemic vaccine against Avian Influenza virus H5N1.

A pre-pandemic Avian Influenza virus vaccine consists in a vaccine that is prepared in advance using viral strains in circulation in areas of the world where sporadic cases of human infection are reported. It is intended to be used immediately after a pandemic is officially declared to provide some protection to the population. During this period, a pandemic vaccine developed specifically for the viral strain identified as the source of the pandemic can be manufactured, a process that takes several months.

Prepandrix™ is a pre-pandemic vaccine based on Avian Influenza virus H5N1 A/Vietnam/1194/04, a viral strain recommended by the World Health Organization (WHO) for this type of vaccine. In clinical trials, the vaccine elicited at least a 4-fold increase in serum neutralizing antibodies in 77% to 85% of subjects against three distinct H5N1 strain variants, A/Indonesia/5/05, A/Anhui/1/05 and A/turkey/Turkey/1/05 respectively.

The vaccine will be stockpiled by European governments in the event of an Avian Influenza virus pandemic and will be administered to people 18-60 years old following immunization plans adopted by member states.

 

Source: GlaxoSmithKline press release, May 19, 2008

Composition of Influenza vaccine for 2008-2009 season

27 February 2008
On February 14, 2008, after reviewing global reports on viral activity, Influenza virus experts of the World Health Organization (WHO) announced their recommendations regarding the composition of the Influenza vaccine for use in the northern hemisphere during the forthcoming Influenza season. A similar meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) took place on February 21, 2008.
 
Both committees recommended the following Influenza virus strains to be included in the vaccines for the 2008-2009 season (November 2008 to April 2009):
  • an A/Brisbane/59/2007 (H1N1)-like virus
  • an A/Brisbane/10/2007 (H3N2)-like virus
  • a B/Florida/4/2006-like virus
 
A recommendation will be made by the WHO in September 2008 regarding the composition of vaccines for the southern hemisphere for the next Influenza season (May to October 2009).
 
 

Sources: WHO press release, Feb. 14, 2008, and FDA press release, Feb. 25, 2008

 

Influenza virus strains recommended by WHO for inclusion in vaccines in recent years

Season Hemisphere Subtype A Subtype B
2007-08     Northern
  • A/Solomon Islands/3/2006(H1N1)-like virus
  • A/Wisconsin/67/2005 (H3N2)-like virus
  • B/Malaysia/2506/2004-like virus
2007 Southern
  • A/New Caledonia/ 20/99 (H1N1)-like virus
  • A/Wisconsin/67/2005 (H3N2)-like virus
  • B/Malaysia/2506/2004-like virus
2006-07 Northern
  • A/New Caledonia/20/99 (H1N1)-like virus
  • A/Wisconsin/67/2005 (H3N2)-like virus
  • B/Malaysia/2506/2004-like virus
2006 Southern
  • A/New Caledonia/20/99 (H1N1)-like virus
  • A/California/7/2004 (H3N2)-like virus
  • B/Malaysia/2506/2004-like virus
2005-06 Northern
  • A/New Caledonia/20/99 (H1N1)-like virus
  • A/California/7/2004 (H3N2)-like virus
  • B/Shanghai/361/2002-like virus
2005 Southern
  • A/New Caledonia/20/99 (H1N1)-like virus
  • A/Wellington/1/2004 (H3N2)-like virus
  • B/Shanghai/361/2002-like virus

Carraguard® is safe as microbicide but does not prevent HIV transmission

18 February 2008
On February 18, 2008 the nonprofit research organization Population Council announced the results of a clinical Phase III trial completed in South Africa with the candidate microbicide Carraguard®. According to the sponsor, Carraguard® proved to be safe for vaginal use in women. Unfortunately, the product showed no efficacy at preventing male-to-female HIV transmission during vaginal intercourse.
 
The clinical trial was initiated in March 2004 and ended in March 2007. It enrolled more than 6,202 seronegative women at three sites in South Africa. The women received either Carraguard® and condoms or a placebo gel and condoms, along with HIV education, risk-reduction and safer-sex counseling. During the trial, there were 134 new cases of HIV infection in the Carraguard® group (an incidence of 3.3 infections per 100 woman-years), and 151 new cases of HIV infection in the placebo group (an incidence of 3.7 infections per 100 woman-years). There was no statistically significant difference between the two groups.
 
Carraguard® is made of carrageenan, a seaweed derivative classified by the FDA as “Generally recognized as safe”. The product had showed efficacy at preventing HIV infection of cells in culture. In addition, it protected mice from infection by other sexually transmitted pathogens. Extensive safety studies had also been completed with success in earlier clinical trials with humans. 
 
The Phase III trial was funded by USAID and the Bill & Melinda Gates Foundation. The Population Council is now developing next-generation microbicides using Carraguard® gel combined with other antiviral compounds.
 
 

Source: Population Council news release, February 18, 2008

FDA grants accelerated approval to Etravirine, a novel non-nucleoside reverse transcriptase inhibitor for HIV/AIDS

18 January 2008
On January 18, 2008 the FDA officially announced the accelerated approval of Tibotec’s experimental drug Etravirine (Intelence, TMC125) as a new drug to treat patients with HIV/AIDS.
 
Etravirine represents a new compound added to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs), which interfere with the activity of HIV reverse transcriptase by binding outside the active site of the enzyme. It is the first NNRTI to be approved since Bristol-Myers Squibb’s Sustiva in 1998.
 
One of the main assets of the new drug is its activity against HIV strains resistant to other antiviral agents including NNRTIs already on the market. FDA’s approval was based mainly on the results of two Phase III clinical trials, DUET-1 and DUET-2. Etravirine will be used in combination with other antiretroviral drugs in treatment-experienced patients who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other drugs. Like previous NNRTI drugs, Etravirine’s side effects include rash. The new drug also shows significant interactions with other compounds used to treat HIV-infected patients.
 
 

Source: FDA press release, January 18, 2008

FDA announces approval of rapid detection test for 4 respiratory viruses

18 January 2008
On January 18, 2008, the FDA announced the approval for market of ProFlu+, a new test manufactured by Prodesse Inc. of Milwaukee. The test is based on real-time multiplex PCR amplification of viral genetic material potentially present in secretions taken from the back of the throat in patients. It is specifically designed to detect Influenza virus type A, Influenza virus type B, Respiratory Syncytial virus subtype A and Respiratory Syncytial virus subtype B. These four viruses are commonly associated with respiratory illnesses such as Influenza, bronchiolitis and pneumonia and are leading causes of lower respiratory tract infections.
 
ProFlu+ is designed as a complement to other diagnostic tools and has the advantage of delivering results in about 3 hours only. The test has already been released on the European market in October 2007.
 
Prodesse Inc. is currently developing other similar tests such as Pro hMPV+ for detection of Human Metapneumoviruses and ProParaflu+ for differentiation of Parainfluenza viruses.
 
 

Sources: FDA press release, January 18, 2008, and Prodesse press release, January 4, 2008

FDA approves new test to detect and identify 12 respiratory viruses from a single sample

03 January 2008
On January 3, 2008, the FDA announced the approval for market of a new test called xTAG Respiratory Viral Panel, which is manufactured by Luminex Molecular Diagnostics of Toronto, Canada. The test allows the specific detection and identification of a series of 12 human viruses causing respiratory illnesses: Influenza A virus (no specific subtypes), Influenza A virus subtypes H1 and H3, Influenza B virus, Respiratory Syncytial virus subtypes A and B, Human Metapneumovirus, Parainfluenza virus 1, 2 and 3, Rhinovirus, and Adenovirus.
 
The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample. It is designed as a PCR-based nucleic acid amplification of specific viral sequences present in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific color-coded microspheres (beads) bind to the amplified viral genetic material and are read by lasers so that the specific virus can be identified.
 
 

Sources: FDA press release, January 3, 2008, and Luminex Molecular Diagnostics website

UNAIDS and WHO release the "AIDS Epidemic Update, December 2007" report

20 November 2007
On November 20, 2007, UNAIDS and the World Health Organization (WHO) released their 2007 report on the AIDS pandemic. The authors stress that direct comparisons between estimates of 2006 and 2007 must be drawn carefully due to refinements in the methodology used to measure HIV incidence and mortality in 2007, along with revised estimates provided by some countries. Analyses found in the 2007 report have been prepared with these remarks in mind and present an increasingly accurate image of the pandemic.
 
Some of the main conclusions drawn in the report are summarized below:
  • 33.2 million people were living with HIV in 2007, including 15.4 million women and 2.5 million children under 15 years
  • 2.5 million people were newly infected with HIV in 2007, including 420,000 children under 15 years
  • 2.1 million people died of AIDS in 2007, including 330,000 children under 15 years
  • Every day, over 6,800 people become infected with HIV and over 5,700 people die from AIDS, mostly because of inadequate access to HIV prevention and treatment services
  • The global HIV prevalence (percentage of people living with HIV) has leveled off and the number of new infections has fallen compared to previous years, in part as a result of the impact of HIV programs
  • The total number of people living with HIV is increasing because of ongoing acquisition of HIV infection combined to longer survival times in a continuously growing general population
  • The global HIV incidence (number of new HIV infections per year) is now estimated to have peaked in the late 1990s at over 3 million new infections, and is estimated in 2007 to be 2.5 million new infections. This reflects natural trends in the epidemic as well as the result of HIV prevention efforts
  • The AIDS epidemic has adopted 2 broad patterns:
    • Generalized epidemics sustained in the general populations of many sub-Saharan African countries, especially in the southern part of the continent
    • Epidemics in the rest of the world that are primarily concentrated among populations most at risk, such as men having sex with men, injecting drug users, sex workers and their sexual partners.
  • Since 2001, the number of people living with HIV in Eastern Europe and Central Asia has increased by more than 150% to reach 1.6 million in 2007
  • Sub-Saharan Africa remains the most seriously affected region, with 22.5 million people living with HIV and AIDS remaining the leading cause of death. However, the number of new HIV infections in 2007 has been significantly reduced compared to 2001

Sources: UNAIDS press release, November 20, 2007, and "AIDS Epidemic Update, December 2007"

FDA grants accelerated approval to Isentress, the first integrase inhibitor for HIV/AIDS

12 October 2007
On October 12, 2007 the FDA officially announced the accelerated approval of Merck’s experimental drug Isentress (Raltegravir, MK-0518) as a new drug in the fight against HIV/AIDS. The compound had been recommended for approval by an FDA advisory committee in September.
 
Isentress interferes with the function of integrase, an HIV enzyme that inserts the genetic material of the virus into host cell’s DNA. This enzyme is unique to Retroviruses, a large and complex family of viruses infecting humans and several animal species. The approval of the first integrase inhibitor represents a major milestone in the treatment of HIV-infected people. The first inhibitors for HIV reverse transcriptase and protease enzymes have been approved in 1987 (Zidovudine) and 1995 (Saquinavir), respectively. More recently, inhibitors blocking viral entry into target cells have been approved for human use, namely Fuzeon (fusion inhibitor, approved in 2003) and Maraviroc (CCR5 co-receptor antagonist, approved in 2007). The integrase enzyme has been a challenging target and several prototype inhibitors have repeatedly failed in early clinical development. Isentress represents the result of years of efforts on the part of Merck’s scientists who showed leadership in this research area. New compounds such as Isentress are needed to treat HIV-infected patients due to the viral ability to develop resistance to antiretroviral drugs.
 
The new drug will be prescribed in combination with other antiretroviral drugs to treatment-experienced HIV patients with limited options.
 
 

Source: Merck & Co., Inc. press release, October 12, 2007, and Antiviral InteliStrat Inc. Database

Antiviral InteliStrat Inc. reaches a new milestone

05 October 2007
Antiviral InteliStrat Inc. proudly announces that its proprietary Database now contains strategic information on more than 1800 compounds and vaccines for viral diseases, compared to about 1700 a few months ago. This represents the largest collection of data of its kind exclusively dedicated to products for the prevention and treatment of infections in humans caused by viruses from one of more than 21 viral families.
 

The Database regroups product files for over 690 inhibitor compounds, 860 vaccines, 140 immunomodulator agents, and 90 antibody products among others. The files detail the nature and properties of the products, mechanism of action, viral resistance, some preclinical and clinical information currently available, along with sponsors and development status. The products included in the database represent all stages of development, from basic research to market status. Several of the products are still in development, while others have been dropped from clinical trials, making the Database a real testimony to the efforts deployed globally by mankind in its fight against viral diseases.

Development of a vaccine for HIV/AIDS stopped prematurely

21 September 2007
On September 21, 2007, Merck & Co. announced that after reviewing data from interim analysis of an ongoing Phase II clinical trial, the decision was made to stop all clinical studies of V520 (MRKAd5 trivalent), a prophylactic vaccine for HIV/AIDS. Two main Phase II trials of the vaccine, each involving more than 3000 healthy volunteers and designed as test-of-concept trials, were ongoing at the time of the announcement. One, the STEP study, was conducted at multiple sites in North America, South America, Caribbean and Australia, while a second trial called Phambili (meaning going forward) was conducted in South Africa.
 
Interim results from the STEP study showed that three inoculations of the vaccine failed to prevent infection by HIV and had no effect on virus load in people who became infected despite receiving the vaccine. V520 consisted in a recombinant Adenovirus type 5 vector expressing the gag, pol and nef genes of HIV-1. Previous trials of the vaccine had shown induction of a strong cellular immune response in people receiving the vaccine, which was expected by many scientists to provide some protection against the virus.
 
 

Source: Merck & Co., Inc. press release, September 21, 2007

An FDA advisory committee recommends approval of HIV integrase inhibitor Isentress

05 September 2007
On September 5, 2007 the FDA’s Antiviral Drug Advisory Committee unanimously voted to recommend approval of Merck’s experimental drug Isentress, which is currently in clinical Phase III development stage for HIV/AIDS. Isentress (Raltegravir, MK-0518) is the first antiviral drug candidate targeting the integrase enzyme of HIV to be so close to final approval by the FDA.
 
Integrase is a unique enzyme that is used by Retroviruses including HIV to insert their genetic material into cell chromosomes. While scientists have succeeded in designing several drugs inhibiting other retroviral enzymes such as reverse transcriptase and protease, the viral integrase has been a very challenging target: all previous drug candidates failed in Phase II clinical trials or earlier in development. Merck’s persistent efforts over the years finally paid off, with Isentress showing potent antiviral activity in patients heavily treated with other drugs and experiencing viral resistance to all major classes of antiretroviral agents.
 
FDA’s final decision on Isentress approval is expected in mid-October. If approved, the new drug will be prescribed in combination with other antiretroviral drugs to treatment-experienced HIV patients.
 
 

Source: Merck & Co., Inc. press release, September 5, 2007

FDA approves smallpox vaccine ACAM2000

01 September 2007
On September 1st, 2007, the FDA officially announced approval of ACAM2000 as a new vaccine for prevention of smallpox, a highly contagious disease caused by Variola virus. ACAM2000, which has been developed by Acambis Inc., will be used to inoculate people at high risk of exposure to the smallpox virus, and will also be available to protect the general population if needed.
 
Variola virus has been responsible for large-scale epidemics in human history that resulted in heavy death tolls, with a mortality rate as high as 30%, and severe disfigurement in many survivors. It took aggressive vaccination campaigns led by the World Health Organization (WHO) during the 1970s to finally succeed in eradicating smallpox. However, several governments are now concerned that Variola virus might be used as a bioweapon. Only limited stocks of first-generation smallpox vaccines are still available and the number of people without immunity to Variola virus has grown substantially. Second-generation smallpox vaccines with improved safety profile and new manufacturing procedures have therefore been developed in recent years for stockpiling in case of emergencies.
 
ACAM2000 is a second-generation vaccine which consists in live Vaccinia virus propagated on Vero cells grown in culture without animal serum. Vaccinia virus is a poxvirus closely related to Variola virus and has been used in smallpox vaccines for a long time. It causes a mild infection in vaccine recipients that elicits a potent immune response, which in turn provides cross-protection against Variola virus.
 
 

Source: FDA press release, September 1, 2007

Antiretroviral drug Maraviroc receives FDA approval

06 August 2007
On August 6, 2007, the FDA officially announced the approval of Maraviroc as a new antiretroviral drug for HIV/AIDS. The drug, which was developed by Pfizer Inc., will be prescribed in combination with other antiretroviral compounds in HIV-infected patients harboring CCR5-tropic virus and showing evidence of viral replication due to resistance to other currently approved anti-HIV agents.
 
Maraviroc represents the first drug to get FDA approval in a new class of inhibitors called co-receptor antagonists, which interfere with viral entry by binding to specific co-receptors used by HIV to attach to target cells. Maraviroc binds only to CCR5 co-receptors, therefore patients must be tested and shown to harbor CCR5-tropic virus in order to benefit from the drug. A box warning on the product label mentions hepatoxicity and cardiovascular events as potential side effects of the drug.
 
The new drug is expected to become available in the US in mid-September and will marketed as Selzentry™, while it will be commercialized as Celsentri™ outside the US. Pfizer has filed several marketing applications around the world and has already received a positive opinion from the CHMP in EU. Maraviroc is already available in several countries under a multi-national expanded access program.
 
 

Source: Pfizer Inc. press release, August 6, 2007

Clinical development of Valopicitabine (NM283) on hold

13 July 2007
On July 13, 2007, Idenix Pharmaceuticals announced that following discussions with the FDA, the decision was made to put all clinical trials of Valopicitabine (NM283) on hold. Valopicitabine was developed in collaboration with Novartis for the treatment of chronic infection by HCV and was currently in Phase II clinical trials. The decision to stop all clinical development was based on data obtained during recent trials showing a significant incidence of gastro-intestinal side effects in patients exposed to the drug. Some of the side effects were serious and appeared even after reducing Valopicitabine dosage in the trials, generating concerns about the overall risk/benefit profile of the drug.
 

Source: Idenix Pharmaceuticals Inc. press release, July 13, 2007

FDA accepts NDA and grants Priority Review for Raltegravir

27 June 2007
On June 27, 2007 the FDA announced it has accepted the New Drug Application (NDA) submitted by Merck for Raltegravir (MK-0518 or Isentress™), the first inhibitor targeting the integrase enzyme of HIV to be considered for approval. In addition, the FDA granted priority review to the application, which applies to products addressing unmet medical needs. Under priority review, a final decision on drug approval can be expected within 6 months of submission.
 
The NDA is based on results from Phase II and Phase III clinical trials in which Raltegravir was administered in combination with other antiretroviral drugs to treatment-experienced patients failing their current therapy due to viral resistance to at least one drug in each of the three available classes of oral anti-HIV drugs.
 
If approved, Raltegravir will be first prescribed in combination with other antiretroviral drugs to treatment-experienced patients infected with viral strains able to replicate despite antiretroviral therapy. These patients represent a growing population of HIV-infected individuals facing limited options once their current treatment fails. Merck is currently conducting other clinical trials in treatment-naïve patients.
 
Raltegravir is already available to certain patients through an expanded access clinical research program. Merck expects formal US approval of the drug by the FDA by mid-October and is going forward to seek approval in other countries.
 

Source: Merck & Co. press release, June 27, 2007

EU license for Viracept temporarily suspended

21 June 2007
European authorities along with Roche have agreed on suspending Viracept’s license for an indefinite period of time. The decision, announced on June 21, follows the recent identification in certain batches of Viracept manufactured in Switzerland of abnormally high residual amounts of methane sulfonic acid ethylester coming from the manufacturing process. The contaminant is a potential carcinogen in animals.
 
Viracept, also known as Nelfinavir, is a protease inhibitor for HIV/AIDS first synthesized at Agouron Pharmaceuticals (later acquired by Pfizer) and FDA-approved in March 1997. Roche manufactures and distributes the drug in several countries outside the US.
 
Soon after identifying the contaminant, Roche announced on June 6 the recall of all batches of Viracept in circulation. Initially, the problem was believed to involve only European countries, but it is now official that several countries around the world are affected by the recall with the exception of the US, Canada and Japan. Roche is working closely with several health agencies to ensure that all contaminated batches of Viracept are removed from distribution channels and that HIV-infected patients can be switched to other antiretroviral drugs.
 

Source: Roche news releases, June 6 and June 21, 2007

FDA issues an “Approvable letter” for Maraviroc

20 June 2007
Pfizer announced on June 20 that the FDA has issued an “Approvable letter” for Maraviroc, the first drug of a novel class of compounds called CCR5 co-receptor antagonists that are designed to prevent infection of cells in patients infected with CCR5-tropic HIV isolates.
 
Maraviroc was expected to receive full approval following the announcement on April 24 of unanimous recommendation by the FDA’s Antiviral Drug Advisory Committee to grant accelerated approval of the drug. Pfizer cited ongoing discussions with FDA to address outstanding questions that remained to be solved before the product receive final approval, along with some labeling issues.
 

Source: Pfizer Inc. press release, June 20, 2007

Antiviral InteliStrat Inc. launches its "Ultimate Database" on antiviral drugs and vaccines

15 May 2007
Antiviral InteliStrat Inc announced today that it has launched a unique database that has no equivalent worldwide. The company has assembled the most complete and detailed database ever made on drugs and vaccines for viral infections in humans. It contains over 1,700 files describing compounds and vaccines developed exclusively for viral diseases by more than 450 sponsors, all accessible on a single web site.
 
Exclusively dedicated to antiviral drugs and vaccines, the database is designed primarily to provide the most up-to-date information to analysts, scientists and decision makers in the pharmaceutical and biotech industry or in the academia who are involved at any level in the discovery and development of preventive and therapeutic treatments for viral diseases.
In addition to drugs and vaccines currently available on the market, the database also contains several hundreds of products that are either filed for approbation by regulatory authorities, still being evaluated in clinical trials, or at earlier stages of development. The database even includes several products that failed at one point during development and were abandoned, products that can still provide valuable information.
 
About Antiviral InteliStrat Inc.
 
Antiviral InteliStrat Inc is a Laval-based society founded by expert virologists, aimed at offering the most recent information to specialists in the domain in order to speed up the discovery and development of novel products for prevention and treatment of viral diseases in humans. The society’s mission is to become the reference for information regarding new antiviral compounds and vaccines. To learn more about the society, visit www.antiviralintelistrat.com.  
 
For more information: Jocelyn Yelle, Ph.D., President, Antiviral InteliStrat Inc., (450) 688-7101, cell phone : (514) 816-8856   jyelle@antiviralintelistrat.com.

The Web site and online database have been realized by K3 Media.

EMEA approves Focetria® for prevention of Avian Influenza virus

08 May 2007
Novartis announced on May 8, 2007 that the European Medicines Evaluation Agency (EMEA) has approved its vaccine Focetria® for use in the event of a pandemic caused by an Avian Influenza virus. EMEA’s decision followed revision of a “mock-up” file prepared by Novartis, detailing clinical data obtained using sponsor’s proprietary adjuvant MF59 and various Avian Influenza virus strains including H5N1 and H9N2.
 
Once a pandemic is declared by the World Health Organization (WHO), a revised application which incorporates the actual viral strain to be included in the vaccine is submitted to EMEA. This procedure accelerates the approval process for the final pandemic vaccine. Novartis has also submitted a separate application to EMEA for approval of an H5N1 pre-pandemic Avian Influenza vaccine based on the same technology and adjuvant used for Focetria®.
 

Source: Novartis AG press release, May 8, 2007

An FDA advisory committee recommends accelerated approval of antiretroviral drug Maraviroc

24 April 2007

On April 24, 2007 FDA’s Antiviral Drug Advisory Committee unanimously voted to recommend accelerated approval of Pfizer’s experimental drug Maraviroc currently in clinical Phase III development stage for HIV/AIDS. Maraviroc (brand name Celsentri) is the first antiviral candidate of a new class of drugs called CCR5 co-receptor antagonists to receive such approval.

If approved, Maraviroc will be indicated only for patients infected with HIV strains harboring CCR5 tropism, since the drug has no significant effect on CXCR4-tropic virus. The long-term effects of CCR5 co-receptor occupancy by this type of drugs are still unknown and will require close monitoring. The final FDA’s decision on Maraviroc approval is expected at the end of June.
 

Source: Pfizer Inc. press release, April 24, 2007

FDA approves the first human vaccine against Avian Influenza virus in the US

17 April 2007
On April 17, 2007 FDA announced approval for the first time in the US of a vaccine designed to protect humans against infection by Avian Influenza virus H5N1, a strain of virus that has caused several deaths in recent years after transmission from infected birds to humans. The vaccine was made by Sanofi Pasteur and the clinical evaluation was conducted by the National Institute of Allergy and Infectious Diseases (NIAID). 
 
The vaccine approval is based mainly on the results of a clinical trial in which 103 healthy adults received two vaccine inoculations, 28 days apart, each of which contained 90 micrograms of Avian Influenza viral antigens. Following vaccine injection, 45% of the volunteers developed virus-specific antibodies at a level expected to provide protection in case of an infection. Lower dosage of vaccine generated a weaker antibody response, but some experts believe it can still be sufficient to provide some protection. The vaccine was associated only with mild side effects.
 
Sanofi Pasteur’s vaccine will not be sold commercially. The US government will stockpile millions of vaccine doses to be used as an early measure in case an H5N1 Avian Influenza virus variant becomes able to spread efficiently from human to human. The vaccine is expected to be used only in the first months of the pandemic, before a vaccine based on the actual pandemic strain becomes available. Other Avian Influenza virus vaccines are being developed by various sponsors.
 

Source: FDA press release, April 17, 2007

Maraviroc will receive accelerated reviews from US and European authorities

21 February 2007

Pfizer announced on Feb. 13, 2007, that Maraviroc will receive accelerated reviews of its marketing authorization applications in US and Europe. Maraviroc is the most advanced compound of a new class of antiretroviral drugs against HIV/AIDS, acting as a CCR5 co-receptor antagonist to prevent viral entry in human cells. Maraviroc is currently undergoing clinical Phase III development and has been made recently available to certain patients under Pfizer's multi-national Expanded Access Program. An FDA Advisory Panel meeting will take place on April 24.

Source: Pfizer Inc. press release, February 13, 2007

Phase II results reported for Bevirimat

15 January 2007

On December 19, 2006, Panacos Pharmaceuticals reported the first results of a Phase IIb trial of its HIV maturation inhibitor called Bevirimat (PA-457). Bevirimat represents the first member of a new class of inhibitors blocking one key step of the viral maturation process. While the data confirmed the product safety along with significant antiviral activity, the oral formulation used in the trial proved inadequate in generating the plasma concentration of Bevirimat required to achieve the desired level of suppression of viral replication. Panacos intends to perform further trials with increased dosage and other formulations of Bevirimat. On December 21, the sponsor also announced the filing of an IND for a second-generation maturation inhibitor of HIV, PA-1050040. Phase I trials for this compound are expected to start in early 2007.

Source: Panacos Pharmaceuticals Inc. press releases, December 19 and 21, 2006

Development of Brecanavir stopped

11 January 2007

On December 18, 2006 GlaxoSmithKline announced the discontinuation of Brecanavir's development program. Brecanavir, also known as GW640385, was a protease inhibitor developed for HIV/AIDS that had reached Phase II clinical trials. The sponsor reported formulation issues as the main cause for terminating Brecanavir development. None of the oral fomulations tested was able to provide the desired blood concentration needed for optimal antiviral activity in treatment-experienced patients.  

Source: GlaxoSmithKline plc press release, December 18, 2006

Approbation by FDA of new Influenza vaccine

09 January 2007

FDA announced on January 8, 2007 the approval of a cold-resistant version (CAIV-T) of Influenza vaccine FluMist® manufactured by MedImmune. The new vaccine is refrigerator-stable and represents an improvement over the current FluMist® formulation which requires freezing. The vaccine is expected to be available for the next 2007-2008 flu season.

Source: MedImmune Inc. press release, January 8, 2007

Conferences

15th Conference on Retroviruses and Opportunistic Infections (CROI)

Boston, MA; February 3-7, 2008    www.retroconference.org/2008/

21st International Conference on Antiviral Research (ICAR)

Le Centre Sheraton Hotel, Montreal, Quebec, Canada; April 13-17, 2008   http://isar.phrm.cf.ac.uk/node/31

18th Annual Clinical Care Options HIV Symposium

Rancho Las Palmas, Rancho Mirage, California; May 1-8, 2008   http://www.clinicalcareoptions.com/