Asbestos victims’ drug hope

VICTIMS of York's asbestos timebomb have been given a major boost after a medicine rationing organisation ruled they are entitled to a vital drug.

The National Institute for Clinical Excellence (NICE) has decided the drug Alimta should be made available to patients with the asbestos-related cancer mesothelioma.

The York Asbestos Support Group today hailed the decision, saying that while the drug was not a cure, it could both extend life and alleviate symptoms for patients and was the only treatment available.

"The NICE decision brings to a conclusion an approval process which started almost three years ago and which led to one of the worst examples of the health postcode lottery," said the group's delighted founder Kim Daniells.

"Hundreds of patients across the UK were refused treatment with this drug whilst those in Scotland, the North West and North East of England could access treatment."

She said NICE had rejected an appeal against an original decision to approve the use of the drug for the treatment of the condition, which was a fatal tumour of the lung pleura caused by exposure to asbestos.

"In the last three years, many hundreds of patients have been diagnosed with the condition and gone on to die without ever being able to access the treatment. Hopefully this situation will now come to an end."

She said NICE's guidance meant primary care trusts would now be obliged to provide uniform treatment.

They would be given the option of a 90-day lead-in period following the official announcement, but she hoped the guidance would result in mesothelioma sufferers gaining prompt access to the treatment they needed and deserved.

The decision could benefit former York Carriageworks employees who fall victim in future to mesothelioma.

Staff were widely exposed to deadly asbestos dust fibres during the 1950s, 1960s and 1970s, and even in the 1980s after some measures had been brought in to provide protection to staff.

Scores of ex-workers have died from the devastating cancer.

A NICE spokesman said Alimta was being recommended as a possible treatment for malignant pleural mesothelioma in people with advanced disease, and whose cancer was not suitable for surgical removal and who met certain other conditions.

Source

Alfacell Signs Onconase Purchase And Supply Deal With Scientific Protein Labs [ACEL]

(ACEL) announced that it has entered into a purchase and supply agreement with Scientific Protein Laboratories LLC or SPL for the commercial production of Onconase or ranpirnase.

Onconase, the company's lead drug candidate, is currently being evaluated as a treatment for unresectable malignant mesothelioma or UMM in a confirmatory Phase IIIb clinical trial.

Kuslima Shogen, chief executive officer of Alfacell, said, “We have been pleased with the superb performance of the extremely well qualified team at SPL for many years and are confident that the commercial production of ONCONASE is in the right hands. This agreement is another step forward for Alfacell as we plan for the commercialization of ONCONASE.”

Onconase is a first-in-class product candidate from Alfacell's proprietary ribonuclease or RNase technology.

In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of Onconase in non-small cell lung cancer or NSCLC and other solid tumors.

ACEL is currently trading at $2.40, up 16 cents or 6.95%.

Source

Vermont Mesothelioma Lawyer Shepard helping Mesothelioma Victims in Rhode Island, Boston, New York, New Hampshire

The Mesothelioma Lawyer expresses his concern over the student’s health risks as asbestos that was used in these old school buildings as the primary insulation and fireproofing construction material is now projecting from the school building sites due to poor maintenance. It is contaminating the schools environment posing students, teachers and the staff to mesothelioma cancer and asbestos related respiratory diseases.

The school going students and the staff working in these schools are exposed to the risk of asbestos related respirator diseases thus laying the foundation for mesothelioma. This fact is also reviled by the Mesothelioma and Asbestos Awareness Centers report. The school buildings in New York have now grown old and need maintenance. Due to lack of maintenance in the old building the asbestos which had been used in construction is now exposed. It is polluting the environment endangering the lives of students, teachers and staff exposing them to the risk of contracting asbestos related respiratory diseases and mesothelioma cancer.

During an emergency inspection in NY schools which was carried as a NY City School was blamed for an incident of asbestos exposure. It was reveled during the inspection that 80% of the building built prior to 1980 used asbestos as insulation and fire proof material during the construction phase. Now due to the poor maintenance the risk of exposure of asbestos has increased manifolds posing risk of health to all the occupants of the school buildings. The report by the Mesothelioma and Asbestos Awareness Centers Report also state that in 2004 one Brooklyn School was forced to open late as they had to ensure the safety of the school building, staff and the students.

Even a small amount of asbestos exposure contaminates the environment, increases the possibility of inhalation of asbestos particles thus marking a start of respiratory disorders leading to mesothelioma cancer.

Mesothelioma lawyer Shepard studies all such cases, takes the path of law to bring relief to the injured who had not known about the risks of being exposed to asbestos. At present Shepard Law Firm is assisting Mesothelioma victims in:

• Boston
• New Hampshire
• Vermont
• Rhode Island

However, due to large network Shepard Law firm enjoys, cases from other areas such as Dallas, New York, Houston and other areas where school buildings are getting old and may be of concern resulting in asbestos exposure can contact: The Shepard Law Firm at http://www.shepardlawfirm.com

To learn more about Mesothelioma / Asbestos Risks visit Mesothelioma Cancer Resource
for free informaation

Source

Alfacell Deals U.S. Rights for Onconase to Strativa

Alfacell Corp. licensed U.S. commercialization rights for the Phase III cancer drug Onconase (ranpirnase) to Strativa Pharmaceuticals in a deal worth up to $225 million.

Just $5 million will change hands up front, but both Alfacell and Strativa stand to gain much more if their gamble in choosing each other as partners pays off. Specifically, Alfacell could get $30 million for FDA approval of Onconase in unresectable malignant mesothelioma (UMM) and up to $190 million for milestones tied to Onconase sales as well as development and commercialization of the drug in additional indications. Alfacell also would receive double-digit royalties and retains a co-promotion option.

For Alfacell, the gamble lies in choosing Strativa, the recently-launched specialty pharmaceutical division of Par Pharmaceutical Cos. Inc. So far, Strativa markets just one product: Megace ES for anorexia, cachexia and unexplained weight loss in HIV patients. Although the company has deals in place for three additional late-stage products, all three are for HIV or cancer supportive care, and Onconase would be Strativa's first true oncology therapeutic.

Lawrence Kenyon, executive vice president and chief financial officer for Alfacell, told BioWorld Today that Onconase has been the subject of "bids from multiple companies for a number of years." Strativa was selected because it had the hunger of a start-up looking to build an oncology business focused on niche products, combined with the resources and infrastructure of Par Pharmaceuticals, he said.

For Strativa, the gamble lies in Onconase's somewhat checkered development history. The drug, a natural ribonuclease isolated from frog eggs, failed a Phase III trial in pancreatic cancer and its first Phase III trial in UMM.

In the pancreatic cancer trial, a preliminary analysis showed that Onconase plus tamoxifen failed to improve survival compared to 5-fluorouracil. Kenyon said part of the problem was an inability to recruit sufficiently healthy patients into the trial, and the pancreatic cancer program subsequently was discontinued. (See BioWorld Today, July 16, 1998.)

The first Phase III UMM trial compared Onconase as a monotherapy to doxorubicin. Again, there was no survival difference in the overall population, but Kenyon said a retrospective analysis showed that the sickest patients had been disproportionately weighted to the Onconase group. Backing them out of the analysis resulted in a two-month survival difference.

Onconase is now being studied in a Phase IIIb trial designed to confirm the positive data seen in the Phase III subset analysis. The trial, which was designed in coordination with the FDA, compares Onconase plus doxorubicin to doxorubicin alone in the less-severe groups of UMM patients. Enrollment of 428 patients is complete, and Kenyon said the company is "very close" to obtaining the number of clinical events needed to analyze the data.

Under the deal with Strativa, Alfacell will continue to fund development, manufacturing and regulatory work with Onconase, including the ongoing Phase IIIb trial. Strativa will fund U.S. commercialization.

Previous deals with US Pharmacia affiliate USP Pharma Spolka Z.O.O. and Genesis Pharma SA cover Onconase commercialization in Eastern Europe and certain Southeast European countries, respectively.

As of Oct. 31, Alfacell reported $5.4 million in cash and equivalents, most of which was earmarked to support the Onconase trial and new drug application filing. Once the filing is submitted, Alfacell intends to work with Strativa on additional indications for Onconase, including the possibility of moving a non-small-cell lung cancer program into Phase II.

Kenyon said the money from Strativa also will allow Alfacell to "ramp up" its preclinical work on AC 03-636 for glioma and antiviral indications, AC CJ-001 for glioma, and AC CJ-002 for non-Hodgkin's lymphoma.

Shares of Somerset, N.J.-based Alfacell (NASDAQ:ACEL) rose 25 cents, or 14.3 percent, to close at $2 on Tuesday. Meanwhile, shares of Woodcliff Lake, N.J.-based Par Pharmaceuticals (NYSE:PRX) rose 52 cents to close at $21.49.

Source

Supreme Court hears ALCOA asbestos suit

Does a company have responsibility for people — other than its own employees — who are exposed to harmful agents from its facilities? That is the question the Tennessee Supreme Court tried to get its arms around Tuesday in Knoxville.
In late 2003, Maryville resident Amanda Satterfield, who was 23 years old at the time, filed a lawsuit against ALCOA Inc. and Breeding Insulation Co. in Blount County Circuit Court.

In her suit, Satterfield charged that she “was exposed to harmful asbestos dust and fibers from the day of her birth from her father’s use of asbestos products and inadvertent introduction of dust and fibers into their home and personal environments.” Satterfield had mesothelioma, a rare cancer directly associated with asbestos exposure.

On Jan. 1, 2005, at the age of 25, Satterfield lost her battle with cancer.
Doug Satterfield, Amanda’s father and the representative of her estate, continued with the suit after her death. With his 18-year-old daughter Amelia at his side, Doug Satterfield cried throughout the hearing in the Tennessee Supreme Court Building in downtown Knoxville.

Doug Satterfield hauled asbestos for ALCOA, starting his career with the company in 1973. He served in the military from 1975 to 1978 and then returned to work at ALCOA. His lawyers have maintained that Doug Satterfield was exposed to asbestos at ALCOA Tennessee Operations and that he brought home harmful dust and fibers on his clothes, resulting in Amanda contracting mesothelioma.

The lawsuit sought $10 million in compensatory and $10 million in punitive damages — although Satterfield has said the case is about justice and doing the right thing, not money.

ALCOA, represented by attorney John Lucas of Knoxville, argued that the ramifications of what the court is considering go far beyond this case, and could possibly create “an infinite universe of potential plaintiffs.”

Lucas referred to Satterfield’s allegations as the “conduit theory” — stating that, by assigning responsibility to companies for third-party contact with harmful agents, the court would define Doug Satterfield as the “vehicle” that transmitted asbestos into his home.

Tennessee Supreme Court Justice William Koch Jr. asked Lucas how that differed from an employee who drove an ALCOA truck into a neighborhood and exposed residents to asbestos.

“How is it negligent for ALCOA to let asbestos fly out of a truck and not negligent for ALCOA to allow employees to go home with asbestos dust on their clothing?” Koch asked.

ALCOA made a similar arguments during a coal tar pitch-related lawsuit in Knox County Chancery Court last year, charging that it would open the “floodgates of litigation” and that Tennessee would become a “plaintiff’s Mecca.” That case is now proceeding with a class action certification hearing following the conclusion of discovery depositions.

Knoxville attorney Greg Coleman, who represents Satterfield, said the real question was “what did ALCOA know, when did they know it, and what did they do about it?
“Public policy should at least extend to the home,” Coleman said. “ALCOA may not have known if an employee would stop at the Waffle House on his way home from work — but they did know that the employee would eventually end up at his home.”
Satterfield’s case has been in the legal system for more than four years. Originally heard — and dismissed — in Blount County Circuit Court Judge W. Dale Young’s court, the Tennessee Court of Appeals reversed Young’s decision, reinstated the lawsuit and charged ALCOA with the cost of the appeal in April 2007.

The Tennessee Supreme Court Justices are expected to issue a written opinion on the case within three months. They can either return the case to Blount County Circuit Court, where it will proceed, or dismiss it entirely.

After the hearing, Doug Satterfield told The Daily Times, “It seems like ALCOA is trying to change the law to protect itself.

“It’s unthinkable that public policy shouldn’t protect the children of workers.”

Amelia Satterfield, Amanda’s younger sister, said she believed the hearing went well, but said her family was nervous about the court appearance.

Coleman said: “ALCOA is trying to reverse what the law should be. They’re saying the greater the magnitude of the harm and the higher the mortality rate, the less responsibility they should have. Where I come from in Ducktown, Tennessee, that’s called bologna.”

The Tennessee Supreme Court should issue its written opinion by early April.

Source

Mesothelioma drug listed on PBS

SUFFERERS of the asbestos-linked disease mesothelioma will have access to cheap treatment from today, after a long campaign to secure federal government subsidy paid off.

The government says the chemotherapy agent Alimta - the only treatment available specifically for the killer cancer of the lung or stomach lining - will be listed on the Pharmaceutical Benefits Scheme (PBS) from today.

Health Minister Nicola Roxon said the listing of Alimta was an important announcement that followed the "tireless campaigning" of Bernie Banton, who died, aged 61, in November from the disease.

"Bernie was a great Australian hero and it is due to his efforts that many people will understand the significance of this decision," she said.

About 600 Australians are diagnosed annually with mesothelioma, but the long lag time between exposure to asbestos and the onset of symptoms means its prevalence is tipped to rise in the future.

Medical studies have estimated 18,000 people will have become victims of the disease by 2020.

Alimta, which can increase survival time and improve a sufferer's quality of life, has been out of reach for many patients at $20,000 or more for six treatments.

From today, sufferers will pay a maximum of $31.30 for each prescription. Eligible concession-patients will pay $5 for each prescription.

The subsidy will cost the government about $26 million annually and is expected to benefit about 300 people a year.

The listing of the drug became an election issue after Mr Banton criticised then health minister Tony Abbott for failing to personally receive a 17,000-signature petition brought to his Sydney electoral office in October.

Mr Abbott was forced into an embarrassing apology after questioning whether the dying campaigner's motives for speaking out were "pure of heart".

A week later, a government-appointed board recommended the drug be added to the PBS after three times rejecting its listing since 2004.

Mr Abbott bypassed the normal process of cabinet approval by immediately announcing the drug's listing.

Until now, only about half of Australians suffering mesothelioma were getting easy access to the palliative care drug through state government subsidy and workplace compensation schemes.

Source

Qld cancer patient welcomes drug subsidy

A Maryborough cancer sufferer has welcomed the placing of a chemotherapy drug onto the Pharmaceutical Benefits Scheme (PBS) this week.

In 1995, 65-year-old Gary Morse was diagnosed with an incurable lung cancer.

He says the chemotherapy and asbestos cancer drug, Alimta, helped him greatly last year.

But he say it would have cost him about $20,000 if his oncologist had not persuaded a private health insurer to pay the cost.

"We have private insurance and he [the oncologist] got in contact with them and got them to agree to pay for the first three treatments and the results were great," he said.

"Then he talked them into paying for the next one and of course now it's come onto the free list, which is better still.

"If we hadn't had private insurance we would have had to take it out of our superannuation retirement fund.

"I know of another one person who's on it, and it's increased his life span, and of course it's also going to increase mine too.

"This year 22 of our family were all together for Christmas, the first time ever, and I thought it was going to be the 'last supper', actually, until this new drug come on the scene.

"Now we can look forward to the future. I'm really pleased with it."

Source