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Week Ending: September 10th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Officials Worry About Infectious Diseases in Hurricane Areas
• Hepatitis C Threatens New Generation of Egyptians
• Top Specialists to Take Part in Hepatitis Symposium
• Reversal of Fortune: Drug Results Drive Vertex Growth
• Liver Replacement Viable with Living Donor Liver Transplant
• Stressgen Granted U.S. Patent Covering Therapeutic Products to Treat Hepatitis B Virus
• Pegylated Interferon-[Alpha]2b and Lamivudine in Hepatitis B E Antigen-Positive Chronic Hepatitis B/IN RESPONSE
• XTL Biopharmaceuticals Loss Cut by 50% For First Half of 2005
• UK: "Many Infants Acquire Hepatitis C Infection from Infected Mothers in Utero"
• Burchinal Tattoo Parlor Closed by Health Department
• Drug-Using MSM and Transgendered Katoey in Thailand Require Culturally Appropriate HIV and Hepatitis C Targeted Prevention
• Shorter Recovery Time after Liver Biopsy Is Safe
• Endoscopic Variceal Ligation Is a Safe and Simple Procedure Now Being Used on a Widening Scale
September 4th, 2005
Officials Worry About Infectious Diseases in Hurricane Areas
http://www.voanews.com
Jessica Berman
Two breeches in the Florida Street levee, looking toward the Mississippi River, are shown Tuesday, Aug. 30, 2005, in New Orleans after Hurricane Katrina moved through the area.
U.S. public health officials are worried about the possible spread of infectious diseases in areas hardest hit by Hurricane Katrina. Stagnant flood waters, lack of proper sewage and clean water all could contribute to the spread of disease.
The conditions in the flooded city of New Orleans are a recipe for diahrreal diseases rarely seen in the United States, including hepatitis, dysentery, cholera, and typhus. The diseases occur when there is no sanitation, and water becomes contaminated with fecal matter.
Officials are also concerned about mosquito-borne illnesses.
Appearing on CNN's Late Edition program Sunday, U.S. Health and Human Services Secretary Michael Leavitt says it is not uncommon to see such outbreaks following natural disasters.
"Any time you have this type of disaster, whether it's in the United States or anywhere else, you have the potential for this kind of disease. For that reason, we have dispatched 24 public health teams, or (we are) in the process of dispatching them, throughout the Gulf region to begin working with state and local officials to assure we are doing everything possible to avoid it," Mr. Leavitt says.
Mr. Leavitt says public health officials will also help victims who are traumatized by the hurricane.
"People have lost their jobs, they have lost their lives, they have lost loved ones, their homes are gone, their mementos, all of the things that make life stable and certain for many of these people are gone, and it's going to exact a devastating toll. And we've got to be there to help them, and we will be," Mr. Leavitt says.
For now, Mr. Leavitt says, federal officials are assessing the immediate health needs of survivors of hurricane Katrina, and mobilizing a coordinated response that may ultimately include offers of assistance from abroad.
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September 5th, 2005
Hepatitis C Threatens New Generation of Egyptians
Source: http://www.alertnet.org/
Mohammed Abbas
CAIRO, Sept 5 (Reuters) - Egyptian children face a high risk of contracting the liver disease hepatitis C from their parents, probably through the use of dirty needles in a country with one of the world's highest infection rates, a medical journal said.
About 14 to 18 percent of Egyptians carry the deadly Hepatitis C (HCV) virus. The disease exploded in Egypt between 1960 and 1970, when unsterilised needles were used during a government campaign to treat the water-borne disease bilharzia.
Now the disease threatens the next generation of Egyptians, according to a study which found that parents could be passing HCV to their children.
"The strong relationship between the risk of infection in a child to the presence of (HCV) in their parents suggests transmission of HCV is occurring between family members," G. Thomas Strickland of the Maryland School of Medicine, Baltimore, said in the study, published in September's issue of the journal Hepatology.
Conducted in rural areas where bilharzia is rife, the study did not find the exact routes of transmission, but said HCV could have been passed on through contact with blood or saliva. In a household environment, HCV can spread by sharing razors or toothbrushes, or by unprotected sex.
But it said the practice within rural Egyptian families of sharing needles was the most probable method of transmission.
"The most common exposures (to HCV) among our subjects were frequent injections ... Usually for health purposes and often given at home by 'injectionists' who sometimes reuse their own needles and syringes or use household-provided syringes and needles in more than one person," Strickland said.
Out of the 6,734 HCV-free Egyptians who took part in the 19-month study, 67 percent of those who went on to contract HCV were under the age of 20, and of those 22 youths, the infection rate was greatest for those under the age of 10.
In his report, Strickland said that although it was difficult to draw statistical significance from the relatively small number of people who contracted HCV, further studies should be conducted into transmission within families.
"Learning the mechanisms by which HCV transmission is occurring between family members so that preventative measures can be initiated, particularly in children having HCV-infected parents, is important," he said.
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Top Specialists to Take Part in Hepatitis Symposium
http://www.gulf-times.com
Hamad Medical Corporation (HMC) is hosting the first Qatar International Hepatitis Symposium from December 14 to 17 under the patronage of National Health Authority chairperson Sheikha Dr Ghalia bint Mohamed al-Thani, Qatar News Agency reported yesterday.
The event, which would shed light on various diseases affecting the liver with emphasis on hepatitis B and hepatitis C and latest developments in diagnosis and treatment, is to have a number of specialists from Europe, China, Middle East and the Gulf region in attendance.
HMC is organising the Qatar Epilepsy and Headache Symposium on September 10 at InterContinental Hotel. A number of international speakers are expected to address the event being organised by the Neurology Section of Medicine Department.
Experts from Switzerland, Lebanon, Saudi Arabia, Belgium and Egypt would join speakers from Qatar at the day-long event that examines the various aspects of epilepsy and headache.
The symposium is to be opened by Dr Ahmed Hamad and Dr Saadat Kamran, on behalf of the HMC, at 8am. The papers scheduled for presentation and their authors are as follows.
First aid for epilepsy and precautions for complications (Dr Hassan al-Hail, Qatar), Epilepsy semiology with long term video monitoring (Dr H G Weiser, Switzerland), Diagnosis and differential diagnosis of epilepsy (Dr Naji Riachi, Lebanon).
Epilepsy in females ( Dr Sonia Khan, Saudi Arabia), Treatment protocol of status epilepticus (Dr H G Weiser), the use of EEG (electroencephalogram) in epilepsy (Dr Mesraoua B, Qatar), Oxcarbazepine in partial seizures (Dr Naji Riachi).
Diagnosis and differential diagnoses of migraine (Dr J Schoenen, Belgium), When and how to treat migraine (Dr Schoenen), Drugs induced headache (Dr Tagelden Sokrab, Qatar), New anti-migraine drugs efficacy and safety profile (Dr Dirk Deleu, Qatar), Comprehensive neuroscience (Dr Youssef Meniawy, Egypt).
Epilepsy is defined as a physical condition that starts in the brain as a neurological condition. It is a symptom that the way a person’s brain works is sometimes disrupted. When this happens, a person may suddenly have a seizure. Many people will have a single seizure at some time in their lives, but this does not mean that they have epilepsy. If a person has epilepsy it means they have had more than one seizure that began in the brain.
The symposium is being held in association with the International League Against Epilepsy (ILAE) and Commission on East Mediterranean Affairs (CEMA).
The ILAE is the world’s preeminent association of physicians and other health professionals working towards a world where no persons’ life is limited by Epilepsy.
The League’s mission is to provide the highest quality of care and well-being for those afflicted with the condition and other related seizure disorders.
The League aims to advance and disseminate knowledge about epilepsy to promote research, education and training, improve services and care for patients, especially by prevention, diagnosis and treatment.
The CEMA has been founded in 2004 with the help of the ILAE.
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Reversal of Fortune: Drug Results Drive Vertex Growth
http://www.bizjournals.com
Mark Hollmer and Michelle Hillman
CAMBRIDGE -- Vertex Pharmaceuticals Inc. plans to secure nearly 150,000 square feet of expansion space in a Kendall Square building it initially backed out of occupying in 2004 -- reflecting a dramatic turnaround in fortunes driven largely by promising results for a new hepatitis C treatment.
Company President, Chairman and CEO Joshua Boger confirmed in a recent Boston Business Journal interview that Vertex would occupy the first three floors of 675 West Kendall over the coming year to help support accelerated clinical development of VX-950.
"We will be growing substantially into that space into 2006," Boger said.
Vertex (Nasdaq: VRTX) hasn't announced how many new jobs will be created by the move, but Boger said the space will support more than 100 research and related positions.
The decision by Vertex to take over much of the building reverses its decision not to occupy the 290,000-square-foot structure as part of a restructuring effort, even though it had signed a 15-year lease agreement and incurred more than $55 million in potential lease obligations as a result.
Boger said the space expansion became crucial, however, because the VX-950 data was "so stunning" that the company has already begun to hire more scientists to help boost research efforts for the drug.
Vertex now targets completing clinical trials and filing for regulatory approval by 2008 as opposed to a much later date. The company briefly referred to its Kendall Square space needs in its 2005 second-quarter financials released last month.
"We need more development folks and we need them fast," Boger said.
Beyond the VX-950 results, the company has advanced clinical trial efforts for drugs to treat cancer and arthritis and also inked a number of new drug-development partnerships with such pharmaceutical companies as Merck & Co. Inc. (NYSE: MRK).
The company's stock hovers near $18 a share, up from $9 a share a year ago after the company completed layoffs, debt refinancing and an overall restructuring of operations.
Capitalizing on the momentum and higher stock price, Vertex raised about $170 million from a stock sale in June that it intends to spend to expand ongoing and emerging research programs.
Vertex lost over $160 million in 2004, but that's an improvement over previous years, and the company reported more than $446 million in cash on hand as of June 30.
Hiring is also on the rise, up to 850 employees and growing, after a low of 700 a few years ago following the sell-off of a division from an acquired business and layoffs following research setbacks.
While Vertex continues to market two HIV drugs with co-developer Glaxo-SmithKline (NYSE: GSK), the company can now boast five compounds to treat various diseases in midstage human clinical trials. In addition to its hepatitis C treatment, Vertex has two other cancer treatments in early-stage human clinical trials.
"It's been a great stock," said Geoffrey Porges, an analyst with Sanford C.
Bernstein in New York. "The company is in a very different position from a year ago."
Porges says investors are paying particular attention to VX-950 despite long-range risks in the overall drug-development process: "VX-950 has the potential to be a billion-dollar drug in what is already a $3 billion market."
Mark Hollmer can be reached at mhollmer@bizjournals.com. Michelle Hillman can be reached at mhillman@bizjournals.com.
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September 6th, 2005
Liver Replacement Viable with Living Donor Liver Transplant
htttp://ww.gastrohep.com
Adult living donor liver transplantation is a viable option for liver replacement, reports September's Annals of Surgery with evidence that older recipient age and prolonged cold ischemia time increase the risk of graft failure.
Previous reports regarding adult living donor liver transplants have been center-specific or from large databases lacking detailed variables.
The Adult-to-Adult Living Donor Liver Transplantation Cohort Study represents the first detailed North American multicenter report of recipient risk.
This study aims to characterize variables predictive of graft failure.
Dr Kim Olthoff and colleagues characterized the patient population with respect to patient selection.
The research team also assessed surgical morbidity and graft failures.
In addition, the team analyzed the contribution of perioperative clinical factors to recipient outcome in adult living donor liver transplantation.
The researchers studied 385 adult living donor liver transplantation recipients from 9 centers.
The team analyzed over 35 donor, recipient, intraoperative, and postoperative variables.
1-year graft survival was 81% – Annals of Surgery
Cox regression models were used to examine the relationship of variables to the risk of graft failure.
The researchers found that 90-day and 1-year graft survival were 87% and 81%, respectively.
The research team observed that 13% of grafts failed in the first 90 days.
The most common causes of graft failure were vascular thrombosis, primary nonfunction, and sepsis.
Biliary complications were common, and the team noted that 30% occurred early, and 11% at a late stage.
The researchers found that older recipient age and length of cold ischemia were significant predictors of graft failure.
Center experience greater than 20 adult living donor liver transplantations was associated with a significantly lower risk of graft failure.
The team noted that recipient Model for End-stage Liver Disease score and graft size were not significant predictors.
Dr Olthoff's team concluded, “This multicenter Adult-to-Adult Living Donor Liver Transplantation Cohort Study experience provides evidence that adult living donor liver transplantation is a viable option for liver replacement.”
“Older recipient age and prolonged cold ischemia time increase the risk of graft failure.”
“Outcomes improve with increasing center experience.”
Ann Surg 2005: 242(3): 314-25
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September 7th, 2005
Stressgen Granted U.S. Patent Covering Therapeutic Products to Treat Hepatitis B Virus
http://biz.yahoo.com
-- New Patent Strengthens Intellectual Property Estate Surrounding Platform for CoVal(TM) Fusions --
SAN DIEGO, CA, Sept. 7 /CNW/ - Stressgen Biotechnologies ("The Company") (TSX: SSB - News) announced today that the U.S. Patent and Trademark Office granted Patent Number 6,921,534 covering fusion protein compositions comprised of a hepatitis B virus (HBV) antigen fused to a heat shock protein (Hsp), as well as DNA encoding such fusion proteins, and methods of treating an HBV infection using these fusion proteins.
Preclinical data from the Company's therapeutic vaccine for hepatitis B, HspBcor, another CoVal(TM) fusion candidate, demonstrate that mice immunized with the HspBcor fusion protein activate cellular immunity by generating cytotoxic T lymphocytes (CTLs), peptide-specific white blood cells that can recognize and kill infected cells expressing the HBV core antigen. This CTL activity was triggered in normal mice that have been genetically modified to contain components of a human immune system, and also in HBV-transgenic mice that express the entire HBV genome.
"In individuals with chronic HBV infection, viral persistence may be related to an insufficient HBV-specific killer T cell (CTL) response," said Marvin I. Siegel, Ph.D., Stressgen's Executive Vice President of Research and Development. "A major hurdle for the development of an effective therapeutic vaccine for HBV is the presumptive existence in many clinical situations of immune tolerance for the HBV antigens. The immunity demonstrated in our animal model is significant because it demonstrates effective immunity in the face of preexisting tolerance."
HBV-transgenic mice are commonly employed as a model of chronic HBV infection. Transgenic mice that are immunologically tolerant to HBV normally do not rid themselves of cells expressing viral antigens. This tolerance is similar to what is observed in humans suffering from chronic HBV infection. Nevertheless, a single injection of HspBcor has been observed to break immune tolerance to the HBV core antigen in some of these transgenic mice by eliciting a specific CTL response, one of the hurdles to an effective therapeutic vaccine for HBV.
About Hepatitis B (HBV):
Hepatitis B is the most common serious liver infection in the world. It is caused by the hepatitis B virus that infects liver cells and can lead to liver failure, cirrhosis or cancer of the liver. Despite the availability of safe and effective preventative vaccines, there are still more than 350 million people worldwide chronically infected with the virus, according to the World Health Organization. Without intervention, each year as many as one million of these individuals will die from HBV-induced disease such as cirrhosis and cancer. According to the Centers for Disease Control and Prevention, more than 1.25 million Americans are chronically infected with HBV, along with 78,000 new infections reported in 2001.
According to the Hepatitis B Foundation, HBV is 100 times more infectious than the AIDS virus. For the 350 million people worldwide who are already chronic carriers of HBV, the existing preventative vaccine, as currently used, is of no therapeutic value.
About Stressgen Biotechnologies Corporation
Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative therapeutic vaccines for the treatment of infectious diseases and cancer. The corporation is publicly traded on the Toronto Stock Exchange under the symbol SSB.
About CoVal(TM) Fusion Proteins
Stressgen capitalizes upon the immunostimulatory powers of heat shock proteins utilizing recombinant technology to fuse, or covalently link, a stress protein with a protein antigen to create a single hybrid protein designed to trigger the immune system to recognize that antigen. For more information about CoVal(TM) fusion technology, or Stressgen, please visit the website located at www.stressgen.com.
This press release contains forward-looking statements that are subject to risks and uncertainties, including those about plans to develop HspBcor for hepatitis B. The actual results may differ materially from the expectations contained in our forward-looking statements due to factors including our need for additional capital. Please refer to our filings with Canadian securities regulators for more information on these and other applicable risks.
For further information
Donna D. Slade, Director, Investor Relations, 6055 Lusk Boulevard, San Diego, CA, USA, 92121, Tel: (858) 202-4900, Fax: (858) 450-6849, dslade@stressgen.com
Source: Stressgen Biotechnologies Corp.
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Pegylated Interferon-[Alpha]2b and Lamivudine in Hepatitis B E Antigen-Positive Chronic Hepatitis B/IN RESPONSE
http://www.rednova.com
TO THE EDITOR: In Chan and colleagues' study of pegylated interferon in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (1), the sustained virologic response (HBeAg seroconversion and hepatitis B virus DNA level less than 500 000 copies/mL) was 36% after 32 weeks of therapy with pegylated interferon-α2b plus 52 weeks of lamivudine. This percentage is comparable with the HBeAg seroconversion rates in 2 global studies investigating combination therapy with pegylated interferon and lamivudine for 1 year (2, 3). In one of these studies, coordinated by our group (2), patients were treated for 52 weeks with pegylated interferon-α2b and lamivudine, and HBeAg seroconversion was achieved in 25% at the end of treatment. In the study by Lau and colleagues (3), patients were treated with pegylated interferon- α2a and lamivudine for 48 weeks and 24% experienced HBeAg seroconversion at the end of treatment.
The 60% HBeAg seroconversion at the end of treatment in the study by Chan and colleagues is very high compared with previous studies, particularly considering the high prevalence of genotype C in their patients, which is probably associated with a less favorable outcome (2). Furthermore, for treatment-naive patients, the study by Chan and colleagues shows a very high percentage of lamivudine resistance (40%) in the lamivudine monotherapy group as determined by the INNO- LiPA assay (Innogenetics N.V., Ghent, Belgium). In the combination therapy group, the rate of lamivudine resistance was 21%. The lamivudine resistance rate in our study was only 11% in the combination therapy group as determined by the same assay. It is tempting to speculate that some of Chan and colleagues' patients were previously exposed to lamivudine therapy. We wonder whether the authors can explain the high end-of-treatment response and the high incidence of YMDD mutants.
Martijn J. ter Borg, MD
Harry L.A. Janssen, MD, PhD
Erasmus Medical Center Rotterdam
3015 GD Rotterdam, the Netherlands
Potential Financial Conflicts of Interest: None disclosed.
References
1. Chan HL, Leung NW, Hui AY, Wong VW, Liew CT, CWm AM, et al. A randomized, controlled trial of combination therapy for chronic hepatitis B: comparing pegylated interferon-alpha2b and lamivudine with lamivudine alone. Ann Intern Med. 2005;142:240-50. [PMID: 15710957]
2. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, et al. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005;365:123-9. [PMID: 15639293]
3. Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352:2682-95. [PMID: 15987917]
IN RESPONSE: We appreciate the interest and comments of Drs. ter Borg and Janssen. In our study, the proportion of patients who achieved HBeAg seroconversion at the end of combination treatment with pegylated interferon and lamivudine (60%) was indeed substantially higher than that reported in 2 other multicenter studies (25% to 27%) (1,2). We agree that this result is surprising, since pegylated interferon was given for 32 weeks in our study compared with a longer treatment duration (48 to 52 weeks) in the other 2 studies. We started pegylated interferon-α2b 8 weeks before the commencement of lamivudine treatment, in contrast to the other studies, which administered the drugs simultaneously. We hypothesize that our staggered administration of an immunomodulator followed by lamivudine might have allowed maximal host immune stimulation by pegylated interferon because reduction of viral load by coadministration of an antivital agent would have been avoided. This hypothesis, however, requires confirmation by future viral kinetics studies using different regimens of combination therapy. We suspect that the inclusion of a significant proportion of patients with previous interferon or lamivudine treatment failure in the 2 multicenter studies might have affected the overall treatment response (1, 2). Hepatitis B virus genotype may not be important in our study because it was not found to influence the sustained virologie response in our patients up to 3 years after treatment (3).
We concur with Drs. ter Borg and Janssen that the rate of lamivudine resistance was high in our report. We did extensive interviews and medical record searches to exclude previous use of lamivudine when we recruited patients. Because lamivudine was registered in Hong Kong in 1999, the year we started our study, a hidden but significant previous exposure to lamivudine seemed extremely unlikely. The rate of lamivudine resistance among patients treated with lamivudine monotherapy in our study (40%) was comparable to that reported by Lau and colleagues (34%) (2). The higher rate of lamivudine resistance as compared with previous early reports may be related to the higher sensitivity of the laboratory tool we use today. We are not certain why our patients receiving combination treatment have a higher incidence of lamivudine- resistant mutations (21%) than in the other 2 studies (11%). The relatively small number of patients in our study may have biased the results. Whether patient ethnicity or viral genotype plays a role will require further investigation.
Henry L. Y. Chan, MD
Joseph J.Y. Sung, MD, PhD
The Chinese University of Hong Kong
Shatin, Hong Kong, China
Potential Financial Conflicts of Interest: None disclosed.
References
1. Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, et al. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005;365:123-9. [PMID: 15639293]
2. Lau GK, Pirarvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352:2682-95. [PMID: 15987917]
3. Chan HL, Hui AY, Wong VW, Chim AM, Wong ML, Sung JJ. Long- term follow-up of peginterferon and lamivudine combination treatment in HBeAg-positive chronic hepatitis B. Hepatology. 2005;41:1357-64. [PMID: 15880608]
Copyright American College of Physicians Sep 6, 2005
Source: Annals of Internal Medicine
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XTL Biopharmaceuticals Loss Cut by 50% For First Half of 2005
http://www.globes.co.il/
Revenue was $2.6 million. XTLbio, which develops hepatitis drugs, attributed improvement to implementation of a new business plan.
Biotechnology company XTL Biopharmaceuticals (LSE: XTL) today announced its financial results for the first half of 2005. XTLbio develops drugs for hepatitis.
The company reported a loss of $5 million for the first half of 2005, a 50% decrease compared with $10 million for the first half of 2004.
XTLbio attributed improvement to implementation of a new plan to focus on the company's core business.
Revenue was $2.6 million compared to $700,000 in the same period last year. Revenue for the period was primarily due to the reimbursement for development expenses for HepeX-B, due to XTLbio's licensing agreement with Cubist Pharmaceuticals and also to in-licensing revenue due to the agreement with Cubist.
In June 2004, XTLbio entered into an agreement with Cubist transferring HepeX-B development activities from XTLbio to Cubist. Under the amended terms of the agreement, (as of August 2005), Cubist paid XTLbio an initial up front nonrefundable payment of $1 million upon the signing of the agreement, and a payment of $1 million (out of which $200,000 was recorded as revenue in the six months period ended June 30, 2005) as collaboration support paid in 2004 (instead of a total of $2 million to be paid in installments through 2005, as in the original agreement).
Also under the amended agreement, Cubist will make a $3 million payment upon achievement of certain regulatory milestones till 2007, or $2 million upon achievement of the same certain regulatory milestones till 2008.
Research and development costs decreased by $4.7 million to $3.5 million from $8.2 million for the first half of 2004. The decrease in R&D costs was due primarily to the absence of expenses related to early stage discovery research activities related to infectious diseases; a decrease in expenses related to the development and clinical program of HepeX-B; the initiation of the collaboration agreement with Cubist; and a decrease in expenses related to the development and clinical program of HepeX-C.
This decrease was partially offset by an increase in expenses associated with XTLbio's HCV-SM program.
General and administrative expenses increased by $200,000 to $1.6 million, compared with $1.4 million in the parallel period last year. The increase in general and administrative expenses was due primarily to costs related to the NASDAQ listing and shareholder meetings.
Business development costs for the first half of 2005 decreased to $100,000 in contrast with $500,000 in the first half of 2004.
As of 30 June 2005, the company's cash and short term investments were $16.6 million, compared with $22.9 million during the same period last year.
Furthermore, the company announced that it had signed an in-license and asset purchase agreement with VivoQuest Inc. which develops compounds for the treatment of Hepatitis C virus (HCV) infection. XTLbio stated that the agreement strengthened further its research capabilities in this field.
XTLbio also listed its shares on Nasdaq and Tel Aviv Stock Exchange and completed the transition of HepeX-B development activities from XTLbio to Cubist. In addition, the FDA granted "Fast Track" designation to the company's XTL-6865 (formerly known as HepeX-C) product.
XTLbio chairman Michael Weiss said, "Trading on Nasdaq and the Tel-Aviv Stock Exchanges provides an important milestone for the company and will help us attract investors and analysts. The company will continue to develop its various clinical products while at the same time, continue to seek in-license or acquire additional candidates or complementary technologies."
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UK: "Many Infants Acquire Hepatitis C Infection from Infected Mothers in Utero"
Women's Health Weekly
Many hepatitis C virus (HCV)-infected infants were infected in utero, according to researchers who investigated when mother-to-child HCV-infection occurs and evaluated associated transmission factors. The prospective cohort study, conducted by J. Mok of University College London and colleagues, included 54 HCV-infected children assessed within three days of birth for HCV RNA polymerase chain reaction (PCR) results.
Of the HCV-infected children, 17 (31 percent) tested PCR positive in the first three days of life and could be assumed to have acquired HCV in utero. Testing positive was not associated with sex (53 percent female vs. 49 percent male, p=0.77) or type of delivery (29 percent elective caesarian section in both groups, p=0.98). Evidence of intrauterine infection was significantly associated with lower birth weight and HCV genotype 1 (58 percent vs. 12 percent, p=0.01).
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Burchinal Tattoo Parlor Closed by Health Department
http://www.globegazette.com
By KRISTIN BUEHNER, Of The Globe Gazette
BURCHINAL — A Burchinal tattoo parlor has been closed by the Cerro Gordo Department of Public Health as an unlicensed and unsanitary tattoo and body-piercing facility, health department officials said today.
Freeky Inks Tattoos, 11979 Second St., is believed to have been administering tattoos and body piercing at its rural Burchinal location illegally for two years, health officials said.
The violation is a serious misdemeanor, punishable by up to $500 and 30 days in jail, said Brian Hanft, environmental service manager for the Public Health Department.
“The message we really want to get across is that people who have had tattoos or body piercing at this establishment need to get tested for HIV and Hepatitis B and C,” he said.
The health department conducts inspections on tattoo establishments for 13 counties in North Iowa. Inspections are conducted to protect the public from diseases that may be transmitted from one person to another through unsanitary or unsafe conditions.
If instruments contaminated with blood are not sterilized or are used inappropriately between clients, there is a risk of transmitting blood-borne pathogens such as HIV and Hepatitis B and C.
Individuals who have received a tattoo or body piercing from Freeky Inks Tattoos are urged to contact Karen Crimmings at the Cerro Gordo County Department of Public Health at (641) 421-9323 or (888) 264-2581, or their local health care provider, for screening.
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September 8th, 2005
Drug-Using MSM and Transgendered Katoey in Thailand Require Culturally Appropriate HIV and Hepatitis C Targeted Prevention
http://www.aidsmap.com/
Edwin J. Bernard
Men who have sex with men (MSM) in Thailand, who often do so with transgendered men known as Katoey, do not perceive themselves to be engaging in sex between men, and are consequently requiring culturally appropriate targeted prevention, according to a study published in the the September 23rd issue of the journal, AIDS. The study also found that substance-using MSM are at high risk of both HIV and hepatitis C infection.
Little is known about the intersection of risk behaviours of MSM with substance use in Asia. Although it is increasingly recognised that they play a substantial role in the HIV epidemics of Thailand, Indonesia, India, China, Pakistan, Vietnam and other Asian countries, it is becoming apparent that traditional Western ideas of what constitutes sex between men do not often correlate with the Asian experience.
For example, in Thai culture there are three genders: male, female and Katoey: the latter are males who adopt female names, roles, and identities, and are perceived as a second category of women. Men who have sex with Katoey do not perceive themselves - and are not perceived by others in Thailand - to be engaging in sex between men.
Aware of the need for more research in this area, the US and Thai researchers sought to investigate MSM behaviours among populations of recovering substance users in Thailand. Their Opiate Users Research (OUR) cohort enrolled 2005 substance-using males over the age of 13 who presented for voluntary drug detoxification for opiate and/or methamphetamine use in northern Thailand.
Of the 2005 OUR cohort members, 1752 (84.7%) reported ever having had sex. Only 3.8% (66/1752) reported ever having sex with men. Of these, most (56/66; 84.8%) reported sex exclusively with Katoey; seven (10.6%) reported sex exclusively with another male-identified man; and three (4.5%) reported sex with both Katoey and with another male-identified man.
Although the MSM were significantly younger (median 25 vs. 30 years) than the heterosexual men, they had significantly higher numbers of lifetime sexual partners (median 20 vs. 6; p=0.0001); reported more female sex partners in the past year (median 2 vs. data not shown; p=0.002); were more likely to have had female paid sex partners (78.8% vs. 46.3%; p<0.0001) and were more likely to have been paid for sex (27.3 vs. 0.3%; p<0.0001) than the heterosexual men in the cohort.
The MSM were significantly more likely to have HIV infection on admission for drug detoxification than the heterosexual men in the cohort (31% vs. 16.2%; OR, 2.32; 95% CI, 1.36-3.96). Prevalence of hepatitis C infection was also greater amongst the MSM (65.2% vs. 41.9%; OR, 2.59; 95% CI, 1.55-4.34). However there was no difference seen in the prevalence of sexual transmitted infections.
Multivariate logistic regression analysis that compared MSM with all other sexually active male drug users found that younger age, Thai ethnicity, greater number of lifetime sex partners, having traded sex for money, and having a Fang Muk (a traditional Thai penile implant) were all independently associated with MSM behaviour. However, having been incarcerated, injection drug history, and being HIV-infected were found not to be independent predictors of MSM behaviour.
The authors concede that a limitation of their study is the absence of Katoey participants. Although the majority of MSM in their cohort reported sex with Katoey, "we do not have data on how many men (or women) self-identified as Katoey. Studies of HIV and other health concerns among Katoey are urgently needed to assess the prevention needs of these transgendered men."
The researchers point out that a Google search for Katoey resulted in more than 25,000 results detailing bars, clubs, dating services and chat rooms, whereas a Medline search "yielded no scientific publications. Although HIV and sexual health research may have overlooked Katoey, the sex and tourism industries have not," they remark.
They go on to argue that targeted prevention strategies "must take into account divergent cultural forms of identity, gender and behaviour", but were encouraged by the high knowledge of HIV infection and prevention reported by the MSM in their cohort.
In fact, MSM were more likely to have had an HIV test prior to engaging in drug detoxification (p<0.0001), more likely to agree with the statement that condoms were effective for HIV prevention (p<0.01), and do not often break or leak during sex (p<0.001) than the heterosexual men in the cohort.
However, they were also more likely to agree with the statement that condoms reduced sexual pleasure (p<0.0001) and that withdrawal before ejaculation can prevent HIV infection (p<0.001).
The researchers conclude that "the high rates of sexual and substance use risks [in Thai MSM] suggest that prevention remains a priority."
Reference
Beyrer C et al. High HIV, hepatitis C and sexual risks among drug-using men who have sex with men in northern Thailand. AIDS 19 (14): 1535-1540, 2005.
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September 9th, 2005
Shorter Recovery Time after Liver Biopsy Is Safe
http://www.gastrohep.com
A shorter observation time after percutaneous liver biopsy is safe, optimizing the use of procedural space and staff in a busy ambulatory care unit, finds this month's Clinical Gastroenterology & Hepatology.
Percutaneous liver biopsy is the gold standard in the diagnosis and staging of a wide variety of hepatic disorders.
Complications, post-procedure monitoring, and recovery time limit the ability for liver biopsies to be performed in a busy gastroenterology community practice.
Dr Roberto Firpi and colleagues from Florida determined if patients requiring percutaneous liver biopsy can be safely discharged after a short recovery.
The researchers evaluated all ambulatory patients undergoing a percutaneous liver biopsy at the University of Florida between 1995 and 2004.
Most complications occurred within 1 hour of observation period, or 24 hours after discharge –Journal of Clinical Gastroenterology & Hepatology
A 15-gauge Jamshidi needle was used after percussion before 2002, while ultrasound guidance started in 2002.
Major complications were defined as events that required either immediate or delayed hospitalization or resulted in death within 2 weeks after the liver biopsy.
The team reported that 3214 outpatient liver biopsies were performed.
During this time, the researchers noted that recovery time was gradually decreased from 6 hours before 1997 to 1 hour in 2002.
The research team found that the majority of the complications occurred within 1 hour of the observation period or within 24 hours after discharge.
The major complication rate was about 2%, regardless of the observation period.
Dr Firpi's team concludes, “A shorter observation time after ambulatory percutaneous liver biopsy is safe and might facilitate the physician's ability to optimally utilize procedural space and ancillary staff in a busy ambulatory care unit.”
Clin Gastroenterol & Hepatol 2005: 3(9): 926-9
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Endoscopic Variceal Ligation Performed Bi-Monthly Is Best
http://www.gastrohep.com
The latest issue of the American Journal of Gastroenterology shows that endoscopic variceal ligation performed for the treatment of esophageal varices at bi-monthly intervals brought about better results than at bi-weekly intervals.
Endoscopic Variceal Ligation Is a Safe and Simple Procedure Now Being Used on a Widening Scale.
Yet most patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices.
Dr Hiroshi Yoshida and colleagues from Tokyo investigated and compared the efficacy and long-term results of endoscopic variceal ligation.
The investigators assessed endoscopic variceal ligation performed in 3 treatments with a total of 16 O-rings at 2 different intervals.
The intervals were bi-weekly, occurring every second week, and bi-monthly occurring once every 2 months.
Variceal recurrence and additional treatment were higher in the bi-weekly group –American Journal of Gastroenterology
A total of 63 patients with esophageal varices were randomly assigned to groups receiving bi-weekly or bi-monthly endoscopic variceal ligation treatment.
The team reported that optimal medical therapy was assessed by 1 medical doctor who was unaware of the patients' treatment assignments.
The investigators evaluated 3 parameters of treatment outcomes including the rate of recurrence, rate of additional treatment, and overall survival.
The overall rates of variceal recurrence and additional treatment were both higher in the bi-weekly group than in the bi-monthly group.
Dr Yoshida's team commented, “Endoscopic variceal ligation performed for the treatment of esophageal varices at bi-monthly intervals brought about better results than the same treatment performed at bi-weekly intervals.”
“The treatments intercalated by the longer interval obtained a higher total eradication rate, lower recurrence rate, and lower rate of additional treatment.”
Am J Gastroenterol 2005: 100(9):
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