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Week Ending: January 27th , 2007
Alan Franciscus
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January 22nd , 2007
Coley Ends Actilon Program, Cuts Staff
http://biz.yahoo.com/
Coley Pharmaceutical Cancles Actilon Development, Lays Off 22 Percent of Staff
WELLESLEY, Mass. (AP) -- Coley Pharmaceutical Group Inc. said Monday it is suspending development of its hepatitis C treatment Actilon and it will lay off about 33 employees, or 22 percent of its staff.
The drug was granted fast-track status by the Food and Drug Administration in May, which meant it faced a quicker review process. Coley said it decided to end the development program after results from a midstage clinical trials showed the drug was not effective.
The company said it will now focus on developing RNA-based treatments.
"The decision to suspend a drug development program is a difficult one," said Robert L. Bratzler, president and chief executive. "However, we are confident that the changes being made today are the right ones for our shareholders."
Aside from laying off 33 employees, the company said it will also outsource its drug development activities. The company expects a charge of $1.1 million during the first quarter because of the layoffs. Cutting the Actilon program is expected to save the company about $15 million in expenses.
Shares of Coley rose 2 cents to close at $9.89 on the Nasdaq, but the stock shed $1.24, or 12.5 percent, to reach $8.65 in after-hours trading, following the announcement.
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Callisto Pharmaceuticals Announces Publication of Research Paper on Atiprimod
http://biz.yahoo.com
NEW YORK, Jan. 22 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals, Inc. (Amex: KAL - News; Frankfurt: CA4 - News), a developer of new drug treatments in the fight against cancer and other major health threats, today announced a recent publication of a research paper on Atiprimod in Molecular Cancer Therapeutics, a journal published by the American Association of Cancer (http://www.aacr.org). The publication, jointly authored by scientists from Callisto and the Institute of Hepatitis Virus Research, describes preclinical data suggesting that Atiprimod inhibited growth of liver carcinoma cells to a greater degree when cells expressed hepatitis B (HBV) and hepatitis C (HCV) viruses than for those cells not expressing these viruses.
According to Dr. Kunwar Shailubhai, Sr. VP Discovery Research, the senior author of the article, Atiprimod has unique properties centering on its ability to selectively inhibit activation of PI-3 kinase/Akt and Jak/STAT3 pathways which are overexpressed in a majority of human cancers.
The research paper entitled "Deactivation of Akt and STAT3 signaling promotes apoptosis, inhibits proliferation, and enhances the sensitivity of hepatocellular carcinoma cells to an anticancer agent, Atiprimod" was published in the January 2007 issue of Molecular Cancer Therapeutics (Volume 6, pages 112-121).
"We are particularly focused on evaluating Atiprimod in advanced carcinoid patients," notes Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "These patients oftentimes exhibit the spread of their carcinoid tumors to their liver, and have proven to be very difficult to treat effectively using approved chemotherapies. Accordingly there are very few options available that offer hope to patients with this cancer."
Atiprimod is presently in a Phase II clinical trial in advanced carcinoid cancer patients, and a Phase I/IIa clinical trial in relapsed or refractory multiple myeloma patients. Callisto earlier announced in June 2006 interim data from a Phase I trial of Atiprimod in advanced cancer patients. The patients who were entered into this trial had growing tumors and symptoms that were no longer controlled by the standard therapies utilized. During treatment, three of the five advanced carcinoid patients had measurable tumor regressions and loss of many of the debilitating symptoms of this disease.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of new drugs to treat various forms of cancer and other serious afflictions. Callisto's drug candidates in development currently include anti-cancer agents in clinical development, in addition to drugs in pre-clinical development for other significant health care markets, including ulcerative colitis. One of the Company's lead drug candidates, Atiprimod, is in development to treat advanced carcinoid cancer, a neuroendocrine tumor, and relapsed multiple myeloma, a blood cancer. Atiprimod is presently in a Phase II clinical trial in advanced carcinoid cancer patients, and in Phase I/IIa human clinical trials in relapsed or refractory multiple myeloma patients, and advanced cancer patients, respectively. Another anti-cancer drug, L-Annamycin, is being developed as a treatment for forms of relapsed or refractory acute leukemia, a currently incurable blood cancer. Callisto initiated a clinical trial of L-Annamycin in adult relapsed or refractory acute lymphocytic leukemia patients in 4Q 2005. L-Annamycin, a new compound from the anthracycline family of proven anti-cancer drugs, has a novel therapeutic profile, including activity against resistant diseases and significantly reduced cardiotoxicity, or damage to the heart, compared to currently available drug alternatives. Callisto also has drugs in preclinical development for gastro-intestinal inflammation, and cancer. Callisto has exclusive worldwide licenses from AnorMED Inc. and M.D. Anderson Cancer Center to develop, manufacture, use and sell Atiprimod and L-Annamycin, respectively. Callisto is also listed on the Frankfurt Stock Exchange under the ticker symbol CA4. More information is available at http://www.callistopharma.com.
Forward-Looking Statements
Certain statements made in this press release are forward-looking. Such statements are indicated by words such as "expect," "should," "anticipate" and similar words indicating uncertainty in facts and figures. Although Callisto believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to be correct. As discussed in the Callisto Pharmaceuticals Annual Report on Form 10-K/A for the year ended December 31, 2005, and other periodic reports, as filed with the Securities and Exchange Commission, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that Callisto will not obtain approval to market its products, the risks associated with dependence upon key personnel and the need for additional financing.
Source: Callisto Pharmaceuticals, Inc.
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January 23rd, 2007
New Culture Method for Hepatitis C Virus Uses Primary Hepatocytes and Patient Serum
http://www.sciencedaily.com
Science Daily — Researchers open the way for improved study of hepatitis C virus by devising a novel virus culture system that allows replication of patient-isolated virus in nontransformed hepatocytes, instead of culture-adapted virus strains in transformed cell lines. The related report by Lázaro et al, "Hepatitis C virus replication in transfected and serum-infected cultured human fetal hepatocytes," appears in the February issue of The American Journal of Pathology.
Hepatitis C virus (HCV) infection affects approximately 170,000,000 people worldwide. HCV liver disease, which may induce liver inflammation, cirrhosis, and/or hepatocellular carcinoma, represents the foremost reason for liver transplantation in much of the U.S.
Study of HCV replication within liver cells, or hepatocytes, has been hampered by a lack of adequate virus culture systems. Some systems allow the virus to infect cells but do not permit prolonged replication and production of virus, while other systems rely on derivatives of permissive virus isolates for efficient replication in transformed (mutated) cell lines. Still lacking has been a system to sustain replication of novel virus isolates from patients using nontransformed hepatocytes.
Nelson Fausto of the University of Washington School of Medicine has crossed this hurdle using a human fetal hepatocyte culture system that was previously developed in his lab. Using this system, his group has demonstrated sustained replication and production of virus particles for at least 2 months, with these virus particles able to infect new cells.
In their first experiments, Fausto and colleagues transfected hepatocyte cultures with HCV genomic RNA and found replication of HCV RNA genomes and production of core protein (for virus particle formation). Release of infectious virus particles was confirmed, as media from these cells were able to infect naive hepatocytes. Finally, virus particles were examined by electron microscopy and shown to possess the expected size and shape of HCV virus particles.
Once the system was established, the group examined whether sera from patients carrying HCV could infect the human fetal hepatocytes. When sera from patients infected with different HCV strains were added to the hepatocyte culture system, viral replication occurred and new virus particles were produced.
In both transfection and infection models, virus particles were released in a cyclical manner, with bursts of virus produced every 10-14 days. This is similar to what has been reported during clinical HCV infection, possibly due to the host's natural defenses. Interestingly, cultured hepatocytes responded to viral replication by displaying signs of distress and cell death and by expressing interferon-beta, a cellular antiviral, in an effort to control the infection.
This culture system provides a breakthrough in studying HCV replication in nontransformed hepatocytes, the natural target of the virus. By allowing infection by patient serum containing a wide array of virus strains, this system may allow better understanding of the differences between different strains, further improving treatment strategies.
This work was supported by grants from the National Institutes of Health and the Center for AIDS Research.
Lázaro CA*, Chang M*, Tang W, Campbell J, Sullivan DG, Gretch DR, Corey L, Coombs RW, Fausto N. Hepatitis C virus replication in transfected and serum-infected cultured human fetal hepatocytes. Am J Pathol 2007 170: 478-489. *These authors contributed equally to this work.
Note: This story has been adapted from a news release issued by American Journal of Pathology.
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January 24th, 2007
China Says Tainted Blood Stocks Have Led to Hepatitis C Infections
http://news.yahoo.com
BEIJING (AFP) - An unknown number of patients in China have contracted hepatitis C after a company distributed tainted blood in one of its immune system-boosting antibody products, the government has said.
Sales of the company's products have been halted while patients who may have used the tainted blood are being tracked down, according to a statement from the Ministry of Health and the State Food and Drug Administration Wednesday.
The statement, posted on official websites on Tuesday, said Guangdong Bioyee Pharmaceutical had acted illegally in its production of immunoglobulin, an intravenous drug for treating immune system deficiencies and viral infections.
The statement said the company, in the southern province of Guangdong, could not produce a complete set of production and inspection records for the products.
It said patients had been infected with hepatitis C, but did not elaborate on how many.
"In order to ensure public safety, the Ministry of Health and State Food and Drug Administration have ordered the halting of sales and usage of that company's immunoglobulin intravenous products," the statement said.
"The Ministry of Health requests that all health organisations follow up on patients who have used those products and to conduct close observations on them," it said.
Hepatitis C is a blood-borne viral infection that can cause severe liver damage. Although many patients can recover quickly from it, people can also die from the related consequences of long-term liver damage.
A patient who had been injected with Bioyee's immunoglobulin product for two months expressed his worries on an Internet chatroom.
"Does God want to take my life already?" the unnamed patient asked in a posting.
"Bioyee has taken so many impoverished people's money, they sell such expensive drugs yet they are engaged in illegal businesses."
Guangdong Bioyee refused to comment Wednesday.
Health scandals due to the unhygienic sourcing of blood have increasingly emerged across China in recent years.
Local authorities allowed blood stations collecting blood through unsanitary methods to be set up in Henan and other provinces in the 1980s to mid-1990s, leading to thousands of people becoming infected with HIV/AIDS.
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Posters Raise Hepatitis C Profile
http://news.bbc.co.uk
A giant poster featuring the face of a local hepatitis C sufferer is going on show on Teesside.
Jonathan Hogg's face will be displayed, alongside others who are also living with the disease, in Middlesbrough town centre on Wednesday and Thursday.
It is part of a national campaign which aims to raise awareness about the disease which currently affects about 200,000 people across England.
There is currently no vaccine, so prevention is particularly important.
Hepatitis C, which is contracted through infected blood, can cause cirrhosis, liver failure or cancer.
'Remove ignorance'
The exhibition was first unveiled in London in March 2005 and has since travelled around England.
The pictures were taken by photographer Michele Martinoli, who has herself been successfully treated for the virus.
Teesside resident Jonathon Hogg decided to get tested in 1999 after sharing equipment with another drug user. He had a feeling that he had hepatitis C and the test confirmed he did.
He said: "Hepatitis C can be spread in a number of ways and can affect people from all walks of life.
"I want to use my experience to help reduce the stigma surrounding hepatitis C and remove the ignorance people with the virus face across Middlesbrough."
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January 25th, 2007
Heavy Drinking Exacts Toll on Women with Hepatitis C
http://www.healthscout.com
Robert Preidt
Imbibing eliminates survival advantage over men, study finds
THURSDAY, Jan. 25 (HealthDay News) -- Heavy drinking slashes the life spans of women with hepatitis C, a new study says.
Publishing in the February issue of Alcoholism: Clinical and Experimental Research, the researchers noted that women with hepatitis C tend to live longer than men with the virus. However, this study found that heavy drinking eliminates that survival advantage in women.
The study analyzed 132,468 hepatitis C- and heavy drinking-related deaths in the Multiple Cause of Death files of the U.S. National Center for Health Statistics.
They found that women with hepatitis C who were not heavy drinkers died at an average age of 61, compared to about age 49 for women who had hepatitis C and were heavy drinkers.
Among men with hepatitis C, heavy drinking lowered the average age of death from about age 55 to age 50.
"Previous studies indicated that alcohol use is a risk factor for HCV (hepatitis C virus) disease progression, but they seldom examined the effect on women and men separately," study author Chiung Chen, a research analyst at CSR Inc., said in a prepared statement. "Even fewer studies were able to examine the effect of alcohol on HCV mortality. Our study provides empirical evidence to fill the gap."
CSR Inc. conducted the study under contract with the U.S. National Institute on Alcohol Abuse and Alcoholism.
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Hepatitis Education Web Site Launched
http://www.advocate.com
A new online hepatitis education campaign for men who have sex with men has been launched by the American Social Health Association, funded by the Centers for Disease Control and Prevention. Both the CDC and the Gay and Lesbian Medical Association recommend that sexually active gay men be vaccinated for both hepatitis A and B.
The program is a comprehensive five-year plan that includes Web-based evaluations and an educational campaign. Visit the site at www.ashastd.org/hepatitis_survey/hepsurvey.html. (The Advocate)
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January 26th, 2007
Japan Approves Roche's Copegus for Hepatitis C
http://asia.news.yahoo.com
ZURICH, Jan 26 (Reuters) - Swiss drugmaker Roche Holding AG said on Friday Japan had approved drug Copegus as a combination therapy with its Pegasys drug for patients with chronic hepatitis C.
The combination treatment has been approved following a fast track review by the Japanese regulatory agency (MHLW), Roche said in a statement.
The approval was based on results from a landmark Phase III Japanese clinical trial which showed that nearly 60 percent of so-called genotype 1b patients with a high viral load achieved a cure, defined as a "sustained virological response", when treated with a combination of Copegus and Pegasys.
The group said 300 Japanese hepatitis C patients were tested.
It is estimated that around 2 million people in Japan are infected with chronic hepatitis C. The disease typically attacks the liver for many years before serious damage to the organ develops.
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