Monogram
Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator
Pfizer, Inc. (NYSE: PFE) has separately announced results from phase III
clinical trials of maraviroc. Monogram’s co-receptor tropism assay,
Trofile(TM), was used for patient selection for maraviroc’s clinical
development program, and the two companies are engaged in a collaboration
agreement to make Monogram’s assay available for patient use on a global
basis.

Pfizer presented pivotal data of its experimental medicine, maraviroc,
which tackles HIV in an entirely new way. Pfizer reported that this data
indicated a significant reduction in viral load. A 24 week analysis showed
that approximately twice as many patients receiving maraviroc with an
optimized background regimen achieved undetectable virus in the blood than
if an optimized regimen was given alone. Pfizer also noted that the new
data, presented at the 14th Conference on Retroviruses and Opportunistic
Infections (CROI), supports the previously announced accelerated U.S. and
European regulatory review of maraviroc as a treatment for patients
infected with HIV that is “CCR5 tropic.” In addition, Pfizer reported that
patients receiving maraviroc and an optimized regimen saw an increase in
CD4 cells nearly twice that seen in those receiving optimized regimen
alone. Adverse events in the group receiving maraviroc plus an optimized
regimen were similar to those receiving an optimized regimen alone when
adjusted for duration of exposure.

Maraviroc is designed to work differently from other available HIV
medications. CCR5 antagonists block the virus from gaining access into
healthy cells via the CCR5 co-receptor, a common pathway for viral entry.
Monogram’s Trofile co-receptor tropism assay identifies whether individual
strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co-
receptors to infect healthy cells. This helps clinicians determine whether
a CCR5 antagonist like maraviroc may be a good therapeutic option for
treating individual patients. Maraviroc is currently under accelerated
review with U.S., Canadian and European regulatory authorities, and if
approved, would be the first new oral class of HIV medicines in more than a
decade.

Maraviroc and other entry inhibitors currently in development come at a
time when increasing drug resistance makes treating HIV more difficult than
ever. Highly sensitive and precise diagnostic tools are playing an ever
more important role in the development of new therapeutic approaches that
give new hope to physicians and patients with few remaining options.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve treatment
of serious infectious diseases and cancer. The Company’s products are
designed to help doctors optimize treatment regimens for their patients
that lead to better outcomes and reduced costs. The Company’s technology is
also being used by numerous biopharmaceutical companies to develop new and
improved antiviral therapeutics and vaccines as well as targeted cancer
therapeutics. More information about the Company and its technology can be
found on its web site at monogrambio.

Forward Looking Statements

Certain statements in this press release are forward-looking. These
forward-looking statements include references to the potential for an HIV
drug that requires a molecular diagnostic for patient selection, expected
protection provided by patents, and activities expected to occur in
connection with the Pfizer collaboration. These forward-looking statements
are subject to risks and uncertainties and other factors, which may cause
actual results to differ materially from the anticipated results or other
expectations expressed in such forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that regulatory
authorities may not require or recommend a molecular diagnostic for patient
selection for an HIV drug, risks related to the implementation of the
collaboration with Pfizer; risks related to our ability to recognize
revenue from activities under the collaboration with Pfizer; risks and
uncertainties relating to the performance of our products; the growth in
revenues; the size, timing and success or failure of any clinical trials
for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the use of
our Trofile co-receptor tropism assay for patient use in the event of
approval of any CCR5 inhibitors; our ability to establish reliable,
high-volume operations at commercially reasonable costs; expected reliance
on a few customers for the majority of our revenues; the annual renewal of
certain customer agreements; actual market acceptance of our products and
adoption of our technological approach and products by pharmaceutical and
biotechnology companies; our estimate of the size of our markets; our
estimates of the levels of demand for our products; the impact of
competition; whether payors will authorize reimbursement for our products
and services; whether the FDA or any other agency will decide to further
regulate our products or services, whether the draft guidance on
Multivariate Index Assays recently issued by FDA applies to our current or
planned products; whether we will encounter problems or delays in
automating our processes; the ultimate validity and enforceability of our
patent applications and patents; the possible infringement of the
intellectual property of others; whether licenses to third party technology
will be available; whether we are able to build brand loyalty and expand
revenues; restrictions on the conduct of our business imposed by the Pfizer
and Merrill Lynch debt agreements; and whether we will be able to raise
sufficient capital in the future, if required. For a discussion of other
factors that may cause actual events to differ from those projected, please
refer to our most recent annual report on Form 10-K and quarterly reports
on Form 10-Q, as well as other subsequent filings with the Securities and
Exchange Commission. We do not undertake, and specifically disclaim any
obligation, to revise any forward-looking statements to reflect the
occurrence of anticipated or unanticipated events or circumstances after
the date of such statements.

Monogram Biosciences, Inc.
monogrambio Continue reading →

Host diversity and host-associated selection driven by the immune system are fundamental to virtually all aspects of infectious disease dynamics.

Here, we examine the potential role of avian immunity in the evolution and global epidemiology of Lyme disease bacteria in the marine transmission cycle.

We show that the seroprevalence and the repertoire of anti-Borrelia antibodies in seabirds vary among locations and seabird species.

These results likely reflect the host specific nature of the tick vector and the life history characteristics of the seabird host species. Understanding the details of the local transmission cycles of vector-borne pathogens is thus critical.

Proceedings of the Royal Society B: Biological Sciences

Proceedings B is the Royal Society’s flagship biological research journal, dedicated to the rapid publication and broad dissemination of high-quality research papers, reviews and comment and reply papers. The scope of journal is diverse and is especially strong in organismal biology

Royal Society B: Biological Sciences Continue reading →

Uganda’s government has obtained antiretroviral drugs to provide 350,000 HIV-positive people with the therapy under its treatment program, Health Minister Stephen Mallinga announced recently, the New Vision/AllAfrica reports. According to Mallinga, 150,000 people currently have access to antiretrovirals, and the government aimed to add 200,000 people to this group. Mallinga said that Uganda’s antiretroviral treatment program is one of the leading programs in Africa, with treatment initiatives available in 11 referral hospitals nationwide. The treatment program also will be introduced in health centers, according to Mallinga. He added that about 25% of people in Uganda are aware of their HIV status and that the program aims to promote HIV/AIDS awareness. Mallinga also noted that HIV/AIDS is contributing to the spread of tuberculosis in the country.

The New Vision/AllAfrica reports that the health ministry has expanded eligibility for enrollment in the antiretroviral program by raising the eligible CD4+ T cell count to 350 from 200. Nathan Kenya, the clinical and community services health director, said the previous enrollment criteria were “getting inadequate” (Buryegyeya, New Vision/AllAfrica, 2/4).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

New research suggests that people infected with human immunodeficiency virus (HIV) may be up to three times more likely to have a stroke compared to those not affected with HIV. The study is published in the January 19, 2011, online issue of Neurology®, the medical journal of the American Academy of Neurology.

“Our findings showed that stroke hospitalizations in the United States decreased by seven percent in the general population within the last decade while stroke hospitalizations for people with HIV rose 67 percent,” said Bruce Ovbiagele, MD, MSc, Professor of Neurosciences at the University of California, San Diego and a member of the American Academy of Neurology.

For the study, scientists reviewed all stroke hospitalizations in the United States within the last decade. The number of stroke diagnoses in the general population declined with 71,742 fewer strokes overall. However, stroke diagnoses among people with HIV increased by 537 more strokes from the start of the decade. For those with HIV, the study showed an increase in ischemic strokes but no increase in hemorrhagic strokes. An ischemic stroke is caused by a blood clot and is the most common type of stroke.

“The average age for a stroke among people with HIV was in the 50s, which is much lower than that of those without HIV. This finding suggests that HIV or HIV treatments may be directly related to stroke occurrence,” said Ovbiagele. “Indeed, one potential explanation is the increasingly widespread use of combination antiretroviral medications in HIV-infected people. While these therapies have greatly increased life expectancy, they may boost the presence of risk factors associated with stroke. Another possibility is that longer exposure to HIV as a result of greater survival, even at low viral load levels, may allow for the virus to increase stroke risk.”

Source: American Academy of Neurology (AAN) Continue reading →

Fears of contracting the H1N1 virus this flu season have people steering clear of strangers with coughs and scolding friends who don’t sneeze into their crooked elbows. With everyone trying to stay germ free, hand sanitizer has become a popular means of protection. But although a quick pump from a Purell dispenser is the most convenient form of hand cleaning, is it the best?

Not necessarily, according to Saint Joseph’s University medical microbiology expert Michael McCann, Ph.D., who recommends washing with soap and water whenever possible. McCann says this-tried-and true method is still the best when it comes to killing germs and protecting your self from the flu.

However, if you can’t get to soap and water, he suggests carrying an alcohol-based, rather than an antimicrobial, sanitizer. The latter contains chemicals like triclosan, which McCann warns, can cause more harm than good.

“The wide-spread use of antimicrobials by the general public may be a literal case of over-kill,” says McCann. “While antimicrobial-containing hand sanitizers and soaps can be very effective at inactivating influenza viruses, over use can be problematic. Research suggests wide-scale application of these sanitizers promotes the evolution of drug-resistant strains of bacteria. Many contain chemicals — like triclosan — that specifically kill bacteria, but do not harm us. The problem is, triclosan can trigger ‘selection,’ which occurs when conditions become favorable or unfavorable for individual bacterium of the same species, based on genetic variation.

In this case, if millions of bacteria are exposed to triclosan, it kills almost all of them. But if one of those bacteria has a genetic mutation that enables it to survive the lethal chemical, then the application of triclosan will select for that individual. Only bacteria resisting the chemical survive.

Descendents of resistant bacteria also carry the mutation, which leads to the generation of large populations of resistant organisms. “This is exactly what has happened with antibiotics, and why strains of bacteria like MRSA (Methicillin-resistant Staphylococcus aureus) are no longer susceptible to many commonly used antibiotics,” he adds.

McCann says studies have shown sanitizers that use alcohol — ethanol and/or isopropyl– are more effective at killing microorganisms and inactivating viruses than triclosan. Further, there does not seem to be a mechanism by which bacteria and other organisms can evolve resistance to alcohols — another reason to use these products.

Source
Saint Joseph’s University Continue reading →

.The Los Angeles Times on Friday examined the “quiet but intense debate” within the Catholic
Church over the use of condoms to prevent HIV infection (Wilkinson, Los Angeles Times, 2/4). Last month,
Spanish Bishops Conference spokesperson Bishop Juan Antonio Martinez Camino — following a meeting with Spain’s Health
Minister Elena Salgado to discuss the fight against HIV/AIDS — said that “condoms have a place in the global prevention of
AIDS,” adding, “The church is very worried and interested by this problem.” Martinez Camino also said the Spanish Roman
Catholic Church is willing to cooperate with the country’s Socialist government — which in November 2004 launched a campaign
promoting condom use — to address the “grave problem” of HIV/AIDS. However, the Spanish Conference of Catholic Bishops later
released an unsigned statement saying that Martinez Camino’s comments “must be understood in the context of Catholic
doctrine, which holds that the use of contraceptives implies immoral sexual behavior.” The bishops went on to say that
sexual abstinence or monogamy are the “only successful” ways to prevent HIV transmission. Pope John Paul II on Jan. 22
reiterated the Roman Catholic Church’s opposition to the use of condoms, saying that “respect of the sacred value of life and
formation about the correct practice of sexuality” is the church’s position on the issue (Kaiser Daily
HIV/AIDS Report, 1/24).

Church Position
Because the church opposes the use of all artificial
contraceptives — including condoms — it often has been called “insensitive to the pandemic spread” of HIV and “more
interested in religious dogma than preserving the lives of tens of millions of people,” according to the Times.
However, the church never has issued a “formal ban” on condoms to prevent HIV infection, rather advocating abstinence and
monogamy to prevent transmission, the Times reports. And while official doctrine has not “wavered,” some senior
church leaders have “explicitly or implicitly sanctioned” condoms in cases where “life is at stake,” doing so with a “tacit
acknowledgement that there are legitimate arguments that morally justify the apparent contravention of a church rule,”
according to the Times (Los Angeles Times, 2/4).

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up
for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for
kaisernetwork, a free service of The Henry J. Kaiser Family
Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

The Los Angeles-based AIDS Healthcare Foundation on Friday criticized the pharmaceutical company Pfizer for an advertisement for its erectile dysfunction drug Viagra that includes the tagline, “What are you doing on New Year’s Eve?” the New York Post reports. The full-page ad, which the company recently printed in the Wall Street Journal, depicts a middle-aged man with a “devilish” grin and states, “Viagra can help guys with all degrees of erectile dysfunction — from mild to severe,” the Post reports (Sanders, New York Post, 12/31/05). AHF President Michael Weinstein called the ad “irresponsible” and “reckless,” adding that it implies erectile dysfunction is not required for Viagra use (AFP/Yahoo! News, 12/31/05). “It is an outrage that, by referencing the biggest party night of the year, Pfizer would employ an advertising strategy that encourages the use of Viagra as a ‘party drug,’” Weinstein said, adding that direct-to-consumer advertising can be misleading, particularly ads that “portray living with HIV to be as simple as popping a pill and then it’s a day at the beach” (AHF release, 12/30/05). Pfizer spokesperson Bryant Haskins said, “Contrary to allegations that the ads promote unsafe sex, our ads specifically urge readers to remember to protect themselves and their partners from sexually transmitted diseases” (AFP/Yahoo! News, 12/31/05).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Viagra. Continue reading →

“National ADAP Monitoring Project Annual Report, 2007,” Kaiser Family Foundation/National Alliance of State and Territorial AIDS Directors: Kaiser and NASTAD on Tuesday released an annual report that looks at state and territorial AIDS Drug Assistance Programs, which are federal- and state-funded programs that provide HIV/AIDS-related medications to low-income, uninsured and underinsured HIV-positive individuals. The report is based on a comprehensive survey of ADAPs in the U.S.; Washington, D.C.; Puerto Rico; Guam; and the U.S. Virgin Islands. According to the report, as of June 2006, 142,000 people were enrolled in ADAPs nationwide, an increase of 5% from 2005. The total ADAP budget was $1.39 billion in fiscal year 2006, with drug costs averaging about $11,897 annually. In addition, the report found that the number of clients receiving antiretrovirals through ADAPs had more than tripled in the last decade. Four states as of last month reported waiting lists for their ADAPs that totaled 571 people, according to the report (Kaiser Family Foundation/NASTAD release, 4/10). The report is available online. A webcast of an event to release the report is available online at kaisernetwork.

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Experts from the World Health Organization on Tuesday met with more than 20 technology companies to discuss how to use technology to detect counterfeit drugs circulating in developing countries, including drugs to treat malaria and HIV/AIDS, Reuters reports (Hirschler, Reuters, 3/13). Ideas the experts discussed at the one-day meeting in Prague, Czech Republic, include bar codes, digital watermarks, holograms and radio tags (WHO release, 3/13). Howard Zucker, WHO assistant director-general for health technology, said experts plan to gather ideas and brief countries about possible strategies within a few months. He added that strategies would be “tailored to country needs based on their resources” because a “one-size-fits-all solution is not going to be the way to move forward.” Harvey Bale, director of the International Federation of Pharmaceutical Manufacturers and Associations, said technology could be helpful in curbing the spread of counterfeit drugs but is not the only solution. He called for stringent legislation and regulations, as well as rigorous enforcement (Reuters, 3/13). According to the most recent figures gathered by a WHO-led task force on the issue, counterfeit drugs make up roughly 1% of sales in developed countries. The proportion is more than 10% in developing countries, and more than 30% of drugs are believed to be counterfeit in parts of Africa, Asia and Latin America. In some former Soviet Union republics, counterfeit drugs account for more than one-fifth of the market (WHO release, 3/13). According to Zucker, the Internet is fueling the problem because it has become a pipeline for counterfeit goods worldwide (Reuters, 3/13).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

The Royal College of Nursing (RCN) responded to the announcement by the Secretary of State for Health, Andrew Lansley, of weekly disclosure of infection levels in hospitals.

Dr Peter Carter, Chief Executive & General Secretary of the RCN, said:

“Nurses have been leading the fight against infections across the health service, and their efforts have resulted in a very significant drop in infection rates. The Secretary of State Andrew Lansley is right, however, to avoid complacency and to offer information to help inform the decisions of patients. The government should now work with nurses and patient groups to look at infection prevention as a whole to ensure that the provision of data alone does not lead to unnecessary ward boycotting, closures or alarm.

“Infection prevention is complex, however it can be dealt with by rigorous clinical management of infection procedures and empowering nurses to take charge. If this type of information is disclosed, we must ensure that it is in a form which the public can usefully interpret, and which will not take nursing staff away from delivering clinical care.”

Source
Royal College of Nursing (RCN) Continue reading →