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Sangart Initiates Phase 1b Study of MP4CO in Patients With Sickle Cell Disease

GFBC NEWS STAFF | 12/01/2012 | 0 Comments

SAN DIEGO, Jan. 12, 2012 /PRNewswire/ — Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen and other gas delivery, today announced the initiation of a Phase 1b study designed to evaluate the safety of MP4CO treatment in patients with sickle cell disease. MP4CO is designed to deliver therapeutic levels of carbon monoxide (CO) to patients suffering from a sickle cell crisis. This initial study will involve patients who are not currently undergoing a painful vaso-occlusive crisis. Preclinical studies show that carbon monoxide stabilizes the hemoglobin of patients with sickle cell disease and prevents the sickling of red blood cells.

“We are encouraged by the preclinical data on MP4CO and look forward to evaluating the safety and potential efficacy of this therapy in helping alleviate pain associated with a sickle cell crisis, while also potentially reducing the severity and duration of a crisis,” said Dr. Jo Howard, at Guy’s and St Thomas’ Hospital, London, UK. “There is currently a dearth of treatments for painful vaso-occlusive crises associated with sickle cell disease, and MP4CO represents a potential treatment option for these patients.”

The clinical trial is a multi-center, randomized, double-blind, controlled study that will enroll approximately 32 clinically stable adult patients with sickle cell disease who are not undergoing a painful vaso-occlusive crisis. The trial will be conducted at four sites across three countries, including the United Kingdom, France and Jamaica. The primary objective of the study is to establish the safety of treatment with MP4CO. The study will comprise ascending dose levels in five groups of single dose infusions followed by three groups of fractionated doses.

“This trial initiation is a key step towards providing a treatment to patients suffering from a sickle cell crisis. The strong preclinical data suggest that a clinical evaluation of MP4CO in patients could yield meaningful results,” said Brian O’Callaghan, President and CEO of Sangart. “Along with our other investigational therapy, MP4OX, we remain committed to developing medicines designed to enhance the delivery of oxygen and other gases to tissues and organs.”

Sickle cell disease is an inherited hemoglobin disorder affecting red blood cell circulation in millions of people around the world. People with sickle cell disease have red blood cells that contain mostly hemoglobin S, an abnormal type of hemoglobin. Due to the presence of hemoglobin S, these red blood cells become crescent or sickle-shaped and have difficulty passing through small blood vessels. When sickle-shaped cells block small blood vessels, less blood circulates through the body, causing severe pain and damage to tissues that do not receive a normal blood flow. This vaso-occlusion is known as a “sickle cell crisis”. There are currently no approved medications to treat sickle cell crises, and only symptomatic relief is available.

About MP4

Sangart’s product platform is based on the MP4 molecule, an investigational biopharmaceutical product designed to enhance the perfusion of oxygen-deprived (ischemic) tissues and provide targeted oxygen delivery in the capillaries. Using a novel pegylation approach, Sangart produces the MP4 molecule designed at the optimal oxygen affinity, diffusion potential and molecular size to perfuse capillaries and target oxygen delivery to tissues specifically at risk of ischemia. MP4 can bind carbon monoxide for delivery to hemoglobin in red blood cells and heme proteins in tissues to provide anti-inflammatory and anti-apoptotic (anti-programmed cell death) effects. Once carbon monoxide has been released, MP4 takes up oxygen, when circulating through the lung, for delivery to ischemic tissues.

Op Ed on elimination of cholera transmission in Haiti and the Dominican Republic

GFBC NEWS STAFF | 11/01/2012 | 2 Comments

Op Ed Published in The Lancet on 11 January 2012

Mirta Roses Periago, Thomas R Frieden, Jordan W Tappero, Kevin M De Cock, Bernt Aasen, Jon K Andrus

One of the largest recent cholera epidemics to affect a single country began in Haiti in October, 2010, just 10 months after a devastating earthquake had struck the nation’s capital. Within a month, cholera had spread throughout Haiti and cases were being reported by its shared island neighbour, the Dominican Republic. In Dec, 2011, 522 335 cholera cases and 7001 deaths had been reported in Haiti,1 with an additional 21 432 cases and 363 deaths reported in the Dominican Republic.2 The 2-year anniversary of the earthquake is an opportune time to refocus national and international efforts on the elimination of cholera transmission in Hispaniola.

In the past year, the international community has supported cholera prevention and control strategies for Haiti and the Dominican Republic.3, 4 These strategies include: improving access to safe drinking water by increasing chlorination of public and household water supplies, increasing water quality monitoring, tracking disease spread and response through surveillance, promoting safe hygiene, encouraging safe food handling practices and policies, and ensuring quality clinical care and treatment at health facility and community levels. If the evidence supports the introduction of oral cholera vaccine in this setting, another tool may be available in the fight against this disease.4, 5 These life-saving interventions must be strengthened and sustained. Despite these efforts, however, there are more than 200 new cholera cases daily in Haiti during the dry season, with more than 1000 cases arising each day in the rainy season.1 Cholera elimination will require renewed efforts to ensure that safe water and sanitation are provided to every resident.

Haiti is the most underserved country in the western hemisphere in terms of water and sanitation infrastructure.6 In 2008, 63% of Haitians had access to improved drinking water and 17% had access to improved sanitation, such as flush toilets, septic tanks, ventilated improved pit latrines, and composting toilets. This low figure for access to sanitation had decreased from 26% in 1990, making Haiti one of the few countries where overall sanitation coverage has declined for reasons other than population growth. By contrast, in 2008, 86% of Dominicans and 93% of people living in the Latin American and Caribbean region had access to improved drinking water, and 83% and 80% had access to improved sanitation, respectively.6 Millennium Development Goal (MDG) 7 encompasses a commitment to halving the proportion of the world’s population without access to improved water and sanitation by 2015. Failure to attain MDG targets in Haiti for access to improved water (74%) and sanitation (63%)7 will facilitate continued cholera transmission on the island, placing the entire region at risk.

During the Latin America epidemic of the 1990s, cholera spread to more than 20 countries in 2 years. With support from the international community, investments in water and sanitation infrastructure contributed to the virtual elimination of epidemic cholera from Central and South America within 8 years.8, 9 These interventions also led to well documented decreases in other waterborne diseases, such as typhoid fever and hepatitis A, and to reductions in infant and child mortality.9, 10 The control of epidemic cholera in Latin America in the 1990s underlines the current need for investment in safe water and sanitation infrastructure in Haiti.

In March, 2010, the international community pledged billions to assist Haiti.11 There has already been major investment by some partners. The USA has committed more than $3 billion in humanitarian relief, recovery, and reconstruction assistance. However, other partners are needed to address the funding gap for water and sanitation infrastructure. To that end, on Jan 11, 2012, the Governments of Haiti and the Dominican Republic launched a call to action for major investment in safe water, sanitation, and hygiene, particularly in Haiti. Future progress will specifically require: prioritising the development of sustainable safe water, sanitation, and hygiene infrastructure; the creation of a technical advisory group of experts to oversee the development of a costed plan of action with a timeline for completion; and honouring pledged post-earthquake funding commitments and recruiting new donors. This effort will not be cheap.12 Estimated costs from the Inter-American Development Bank, the Office of the Haitian Prime Minister, and the World Bank have ranged from $746 million to $1·1 billion.7, 13 However, the benefits would be enormous. Answering this call to ensure access to clean water and improved sanitation in Haiti will decrease the burden of cholera and other diarrhoeal diseases and prevent the further spread of cholera beyond the island of Hispaniola.

MRP is Director of the Pan American Health Organization. TRF is Director of the Centers for Disease Control and Prevention. JWT is Director of the CDC’s Health Systems Reconstruction Office. KMDC is Director of the CDC’s Center for Global Health. BA is Regional Director for Latin America and the Caribbean for the United Nations Children’s Fund. JKA is Deputy Director of the Pan American Health Organization. We declare that we have no conflicts of interest.

Heavy D died of Pulmunary Embolism (blood clot in the lungs)

GFBC NEWS STAFF | 27/12/2011 | 1 Comment

GFBC NEWS NETWORK

December 27, 2011

Heavy D

According to the Loa Angeles coroner’s report, Heavy D real whose real was name Dwight Myers died of Pulmonary Embolism. The coroner’s report also stated, “manner of death: natural.” But Heavy D also could have died from a pulmonary embolism, a fatal consequence of sitting for prolonged periods of time during long distance travel. Pulmonary embolisms are often misdiagnosed as something else — such as pneumonia or cardiac arrest.

A pulmonary embolus clogs the artery that provides blood supply to part of the lung. The embolus not only prevents the exchange of oxygen and carbon dioxide, but it also decreases blood supply to the lung tissue itself, potentially causing lung tissue to die.

He he died of blood clots in his lung that traveled from his legs (deep vein thrombosis, or DVT). The late Heavy D, had adopted a fitness routine and had lost a substantial amount of weight. Heavy D, collapsed outside his Beverly Hills condo after he suffered difficulty breathing while returning from a morning shopping trip, police said at the time. He later died at Los Angeles Cedars-Sinai Medical Center.

CARIBBEAN RUM BALLS ISSUES ALLERGY ALERT ON UNDECLARED ALERGENS IN “RUM BALLS”

GFBC NEWS STAFF | 25/11/2011 | 3 Comments

Caribbean Rum Balls of St. Thomas, VI, is issuing an alert about rum balls with packaging that do not declare specific allergens: wheat, coconut, milk, eggs and sodium bisulfite (a preservative).

The problem was caused by a temporary breakdown in the production and packaging processes, the company said in a news release. It added that all the products are being relabeled with new ingredient listings, including sub-ingredients, and citing allergens. No illnesses have been reported, but people who have allergies to any of these ingredients run the risk of serious or life-threatening allergic reaction if they consume these products. The rum balls, distributed locally in retail stores and via mail order, come in 4, 8 and 12 ounce, white packages with the Caribbean Rum Balls name and logo.. Consumers with questions may contact the company at 1-340-775-6616.

HEAVY D Autopsy completed toxicology report unkown

GFBC NEWS STAFF | 14/11/2011 | 2 Comments

GFBC NEWS NETWORK

November 14, 2011

It has been reported that Heavy D, real name Dwight Arrington Meyer’s autopsy has been completed; however the corner’s office has declined to release a cause of the death until the results of the toxicology can be confirmed. According to several media outlets the late rapper had been on a weight loss fitness routine and was in a regular workout routine.

Rapper Heavy D,

Speculation has begun to spread that obesity played a role in the death of the 44 year old rap star. According to the coroner’s office Heavy D weighed 344 pounds at the time of his death. The Los Angeles County coroner’s office did confirm that “He had what appeared to be flu-like symptoms”, Ed Winter, from the Los Angeles County Coroner’s Office reported to the New York Daily News. “He was taking medication, so we want to see what the levels were”.

Weighing in at 344 pounds when he died, Heavy D was morbidly obese, which made him more susceptible to a host of health problems.

South Korea cosmetic surgery no longer taboo!!!!

GFBC NEWS STAFF | 06/11/2011 | 1 Comment

By CHOE SANG-HUN

SEOUL — With a blue pen, Dr. Seo Young-tae drew arches on Chang Hyang-sook’s eyelids, marking where to cut and stitch to create a new fold to make her eyes look larger and rounder. It is an operation so common here that most women on Seoul streets seem to have a double fold, though only one of every five Koreans is born with one.

Jean Chung for the International Herald Tribune Chang Hyang-sook, a makeup artist, paid the 2.3 million won, or about $2,000, to make her eyes look larger and rounder.

“Promise you’ll do a great job on my eyes,” Ms. Chang said to Dr. Seo. “Never mind the pain. I can take it.”

For Ms. Chang, 25, a makeup artist, the 2.3 million won, or about $2,000, eye job is just the finishing touch in a program several months long to remake her face. In the previous two months, Ms. Chang had not only had her teeth rearranged, but her jaw bones cut and repositioned, for 22 million won.

“You must endure pain to be beautiful,” she said, adding that an eye job is so routine these days “it’s not even considered surgery.”

Cosmetic surgery has long been widespread in South Korea. But until recently, it was something to keep quiet about. No longer.

And as society has become more open about the practice, surgeries have become increasingly extreme. Double-jaw surgery — which was originally developed to repair facial deformities, and involves cutting and rearranging the upper and lower jaws — has become a favorite procedure for South Korean women who are no longer satisfied with mere nose jobs or with paring down cheekbones to achieve a smoother facial line.

Celebrities have helped to drive the trend, as they scramble to keep ahead of digital technology that mercilessly exposes not only their physical imperfections, but any attempts to remedy them, said Rando Kim, a professor of consumer science at Seoul National University.

“Wide-screen and high-definition TV put pressure on them to look good in close-ups,” Mr. Kim said. “And with the Internet, where people like to post ‘before’ and ‘after’ pictures, they can no longer hide it. So they go public, often talking proudly about it on TV.”

That, in turn, has encouraged greater openness among ordinary South Koreans.

“It used to be all hush-hush when mothers brought their daughters in for a face-lift before taking them to match-makers,” said Dr. Park Sang-hoon, head of ID Hospital. “Now young women go plastic surgery shopping around here.”

Dr. Park’s is a top-ranked clinic in Seoul’s “beauty belt,” a swarm of hundreds of plastic surgery clinics clustered around a string of subway stations in the upscale districts of southern Seoul.

“Where did you get it?” asks one of the ads for clinics that cover the walls at the entrances of the Apgujeong subway station, the center of the beauty belt. “What about your nose? And your chin?”

Parents may promise their daughter an eye job if she passes her college entrance exam. In Apgujeong, it is not hard to find young women shopping in department stores immediately after their surgeries, wearing masks or sunglasses.

“Korean women want a revolution with their face,” said Dr. Park, a leading practitioner of double-jaw surgery.

“What we do in double-jaw surgery is to reassemble the face,” said Dr. Park, whose clinic has performed 3,000 such procedures in the past six years. “Normal people become, sort of, super-normal, and pretty people prettier.”

In traditional Korea, tampering with the body bestowed by one’s parents was a violation of Confucian precepts that also discouraged cremation and, later, organ and blood donations.

But in recent decades, cosmetic surgery has become a weapon in Koreans’ efforts to impress others, “like buying an expensive handbag,” said Whang Sang-min, a psychologist at Yonsei University.

Cosmetic surgery is not covered by national health insurance, making it difficult to determine the exact size of the industry. A survey last year by the Seoul city government found that 31.5 percent of residents 15 or older were willing to undergo surgery to improve their looks. In 2007 the percentage was 21.5.

In a 2009 survey by the market research firm Trend Monitor, one of every five women in Seoul between the ages of 19 and 49 said they had undergone plastic surgery.

Chavez to Cuba for fourth round of chemotherapy

GFBC NEWS STAFF | 17/09/2011 | 0 Comments

Caracas. Venezuelan President Hugo Chavez said he would travel to Cuba for a fourth round of chemotherapy to treat his cancer Sunday, saying it would “most likely be the last” round in the treatment, AFP reported.

Hugo Chavez

After meeting here with visiting Bolivian President Evo Morales, on an “unofficial” visit to comfort Chavez during his ailment, the Venezuelan leader said he would leave for Cuba later Saturday and begin treatment, adding that he expects to return midweek.
Chavez, who had a tumor removed June 20 in Havana, has expressed confidence it would be his last before his “full recovery.”
Cuban officials cited in state media said Morales would also travel to Cuba, on Sunday, for a two-day visit that will include “a working meeting” with Cuban leader Raul Castro, and to receive an honorary doctorate from the University of Havana, where he will also give a lecture.
Little information has been released about the type of cancer afflicting 57-year-old Chavez, or details about his medical condition.
He underwent his first two rounds of chemotherapy in Havana, where doctors discovered the cancer after operating on him for an abdominal abscess.
On September 2, he concluded a third round at a Venezuelan military hospital.
Chavez, who has been in power since 1999, said he was confident he will be “fully recovered” to serve as host of a summit of Latin American and Caribbean leaders December 2-3 in Caracas.
The summit, which marks the creation of the Community of Latin American and Caribbean States, was originally scheduled to be held in July but was postponed after Chavez learned he had cancer.

Source: Focus Information Agency

Mobay Hosts International HIV Conference

GFBC NEWS STAFF | 23/08/2011 | 0 Comments

MONTEGO BAY â€” Approximately 275 delegates representing 21 countries in the Caribbean and Latin America are participating in the International HIV Management Conference, which opened at the Hilton Rose Hall Resort, Montego Bay, on Sunday August 21. The conference will continue over six days under the theme, â€œHarmonizing Quality Clinical Care and Laboratory Diagnostics on Behalf of Persons Most at Risk of HIV/AIDSâ€, and is being held in Jamaica for the first time. It brings together three important forums: the 8th Caribbean Cytometry and Analytical Society (CCAS) HIV/AIDS Workshop; the Jamaica National HIV/STI Programme's 8th Annual HIV Management Workshop; and the CCAS and Caribbean Medical Laboratory Foundationâ€™s (CLMF) Collaborative Meeting. Minister of Health, Hon. Rudyard Spencer, in an address read by Director of the Western Regional Health Authority, Dr. Ken-Garfield Douglas, said that an event of such magnitude, bringing together regional delegates integral to the fight against HIV and AIDS, symbolised Caribbean unity on the subject.

The conference will continue over six days under the theme, â€œHarmonizing Quality Clinical Care and Laboratory Diagnostics on Behalf of Persons Most at Risk of HIV/AIDSâ€, and is being held in Jamaica for the first time.

It brings together three important forums: the 8th Caribbean Cytometry and Analytical Society (CCAS) HIV/AIDS Workshop; the Jamaica National HIV/STI Programme’s 8th Annual HIV Management Workshop; and the CCAS and Caribbean Medical Laboratory Foundationâ€™s (CLMF) Collaborative Meeting.

Minister of Health, Hon. Rudyard Spencer, in an address read by Director of the Western Regional Health Authority, Dr. Ken-Garfield Douglas, said that an event of such magnitude, bringing together regional delegates integral to the fight against HIV and AIDS, symbolised Caribbean unity on the subject.

â€œNo country is exempt. It is thus fitting that we come together and share our knowledge, ideas and expertise, as we aim for one ultimate goal: Halting and reversing the spread of the disease,â€ the Ministerâ€™s statement read.

He said that, as the world inched closer to 2015, the target year for meeting the United Nations’ millennium development goal of combating HIV/AIDS, the collaboration of countries in the fight against the disease becomes even more critical.

He added that operating in an environment of declining budgets, requires that countries take a unified approach on the issues.

â€œThe amalgamation of human and financial resources must become a reality, to achieve any significant decrease in individual vulnerability to HIV infection and improvement in treatment, care and support services for people living with the infection in the region,â€ the minister noted.

He indicated that throughout the region, there was an 18 per cent decline in the number of persons reported with advanced HIV and AIDS cases in 2009, compared to the previous year.

He reassured that the Government of Jamaica remains deeply committed to the fight against HIV and AIDS, and has an unfinished agenda in eliminating the stigma and discrimination against those infected and affected by the disease.

He said that the Government is planning amendments to the Public Health Act, and the relevant public health regulations, as one way of moving the agenda forward.

â€œThe intention is for HIV and AIDS to remain as notifiable diseases, but certain provisions in the regulations that would be regarded as discriminatory would be removed, because they do not apply with respect to HIV and AIDSâ€, he disclosed.

However, the Minister pointed out that the task was formidable, and requires maintaining the level the kind of resiliency which has resulted in encouraging progress, so far.

Source: JIS

Recall of Similac Powdered Baby Formula

GFBC NEWS STAFF | 23/09/2010 | 0 Comments

Source: Web MD

Sept. 22, 2010 — Illinois-based Abbott Laboratories says it is recalling about 5 million containers of its top-selling Similac powdered infant formula due to possible contamination by beetles or larvae of the bugs.

Abbott spokeswoman Melissa Brotz tells WebMD that the product being recalled is sold in cans and plastic containers, and that only the powdered versions of the popular infant formula is involved in its â€œproactiveâ€ action.

Similac sold in liquid form is not part of the recall, Brotz says.

â€œWe know that parents place a lot of trust in our Similac brands and delivering anything less than the highest quality infant formula to them is unacceptable to us,â€ she tells WebMD. â€œWe will do whatever is necessary to maintain that trust in the coming weeks and months.â€
Recalled Similac Could Cause Illness

The company said in a news release posted on the web site of the FDA that an internal quality review detected the â€œremote possibility of the presence of a small common beetle in the product producedâ€ in one of its manufacturing facilities.

Abbott says the FDA had determined that while the formula containing the beetles â€œposes no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract.â€

A doctor should be consulted if symptoms persist for more than a few days, Abbott says.

It also says the powder infant formulas include Similac powder sold in plastic containers and certain product lines sold in 8-ounce, 12.4-ounce, and 12.9-ounce cans.

It says consumers desiring more information or to find out if they have the product in their possession should go the web site similac.com and type in the lot number. Or people may call 800-986-8850.

Abbott says it has begun an investigation into the issue.

Holger Liepmann, executive vice president of Abbott Nutrition, says in a news release it is taking steps to assure parents that the companyâ€™s products â€œmeet the highest quality standards for which they are known.â€

Liepmann also says the company regrets â€œany inconvenience this situation poses to parents and consumers.â€

The plant involved is in Sturgis, Mich., Brotz says. The recall involves Similac products sold in the U.S., Guam, Puerto Rico, and other markets in the Caribbean.

Closeted Calamity: The Hidden HIV Epidemic of Men Who Have Sex with Men

GFBC NEWS STAFF | 26/08/2010 | 1 Comment

By Bob Roehr

The HIV pandemic has historically been thought of as either concentrated in specific populationsâ€”such as gay men, injection drugâ€“users, sex workersâ€”or generalized across the entire population in sub-Saharan Africa and the Caribbean. But as more and better epidemiological data has become available, the evidence is clear: men who have sex with men (MSM), regardless of whether or not they identify as gay, also are at the core of those generalized epidemics.

MSM in developing countries are 19 times more likely to be infected with HIV than the general population, according to a 2007 literature review.

Even in Africa, at the heart of the pandemic, in Malawi, 21 percent of MSM are infected with the virus compared with 11 percent of the general population, whereas Zambia’s rates are 33 percent versus 15 percent, respectively, says Chris Beyrer, director of the Johns Hopkins Center of Public Health and Human Rights.

“The argument that gay and bisexual men are a trivial sideshow in the global fight against AIDS is wrong,” he told the Global Forum on MSM and HIV, an advocacy network that met this summer prior to the International AIDS Conference in Vienna, Austria.

That epidemiologic evidence has largely have been ignored by most nations’ plans for HIV prevention and care. Cultural valuesâ€”machismo, homophobia and religion have overridden the data and dominated policy decisions in many places; most recently in the news are Uganda and Malawi.

Some 85 countries still criminalize sexual activity between adults, and eight, including Nigeria and several Islamic countries, impose the death penalty for homosexual acts. Uganda has been embroiled much of the past year in a debate about whether or not to write such a death penalty into their statutes, with evangelical Christians, both local and in the U.S., fanning the flames.

A recent survey of 303 MSM in Kampala, Uganda, found that 37 percent had been physically abused at some point in their lives, 37 percent had been blackmailed and 26 percent had been forced to have sex, according to Joseph Baker, a researcher with the U.S. Centers for Diseases Control and Prevention (CDC).

Even more troubling, members of this group were five times more likely to be infected with HIV. The overall HIV prevalence was 4.5 percent in adult males in Kampala, 13.7 percent among those participating in the survey and 22.4 percent among those who had experienced violence.

“We have a situation where laws and their arbitrary, inappropriate enforcement are increasing risk and vulnerabilityâ€”thereby imposing barriers to effective HIV responses for those most vulnerable and the general population,” says Jeffrey O’Malley, director of the United Nations Development Programme (UNDP) HIV Group.

Joint United Nations Programme on HIV/AIDS (UNAIDS) Executive Director Michel Sidibe says discrimination against MSM is a human rights issue and unacceptable. But his message seems to be compartmentalized, reserved for preaching to the choir of those working with MSM; his speech to the Global Forum is absent from the UNAIDS Web site.

The recent International AIDS Conference reinforced the trend: Just 2 percent of presentations focused on gay and bisexual men, according to George Ayala, executive officer of the Global Forum.

This trend toward scientific omission has reinforced local social stigma and violence directed against this minority. The results are an amplification of new infections that might otherwise have been reined in, and a continued expansion of the pandemic.