ASBESTOS NEWS DAILY - MESOTHELIOMA DRUGS
Dastanib - New Drug for Mesothelioma Under Trial
2009-10-06 02:30:54 (GMT) (Caymanmama.com - Mesothelioma News News)
Dallas,TX: Many drugs and treatments methods have been tested and tried on selected group of mesothelioma patients time and again. No cure has yet been discovered. New hope has arisen in mesothelioma patients with the discovery of a new drug named Dastanib. This drug is under study and clinical trials of the same are underway atM.D.CancerCenter -University ofTexas and in different centers in theUS.
The selected patients in theAnderson cancer center are receiving an additional and exceptional care through a dedicated team of doctors, who have been assigned specific roles for the treatment of different jobs, for the better treatment of these patients. This team is based on experts in thoracic medical oncology, radiation and pulmonary and pathological fields.
Dastanib, is useful for those mesothelioma patients, who are not responding to other available therapies or those who are unable to consume some drugs due to allergic reactions, or those, in whom, some side effects cause some trouble.
Mesothelioma is scary and till now, like other forms of cancer, is incurable. Though many asbestos industry workers are infected with this disease and many efforts have been made by the researchers to find a cure to this rear yet lethal disease but the researchers have failed to come up with any permanent cure for mesothelioma cancer and the victims, who have little time left to live, are forced to take up therapies like radiation therapies, chemotherapy etc.
TheM.D.CancerCenter atUniversity ofTexas is trying its level best, through the introduction of this drug, to reduce and prevent the progression of this disease.
Report Claims Alimta Caused Lung Injury in Mesothelioma Patient
Posted on September 16th, 2009
by Deon Scott in All News
It has been claimed that a recent report that was published in a Japanese medical journal blamed the drug Alimta for causing lung injuries to a man who was suffering from the asbestos cancer mesothelioma. This is a drug that is used to treat this form of cancer, and is also known as pemetrexed.
The sixty five year old man was apparently taken to hospital because he was short of breath according to the report. An xray was then carried out on the patient, and the results are said to have revealed that he had a build up of excess fluid in the left pleural cavity.
Following analysis of a sample taken during a biopsy it was determined that the man was suffering from malignant mesothelioma, and as a result he was started on a course of chemotherapy, which included the use of pemetrexed.
However, the report claims that following the start of the chemotherapy the patient experienced problems, and this included shortness of breath and fever. It was suggested that the patient had experienced drug-induced interstitial pneumonia. He eventually died from respiratory failure, and researchers said that “this is apparently the first reported case of pemetrexed-induced acute lung injury.”
Lilly’s Alimta May Help Lung Cancer Patients Live Months Longer
By Elizabeth Lopatto - May 30, 2009 (Bloomberg) -- Eli Lilly & Co.’s lung cancer drug Alimta may help lengthen lives of patients whose disease is in remission, according to a study that may lead to a new treatment strategy for the malignancy.
Patients either took Alimta or a placebo every 21 days after their disease had been controlled with a standard therapy. People taking the drug lived 3 months longer overall than those on placebo, according to the Indianapolis-based company’s research being presented today at the American Society of Clinical Oncology meeting inOrlando,Florida.
More patients die from lung cancer than from any other form of the disease, according to the U.S. Centers for Disease Control and Prevention. The data have been submitted toU.S. regulators and are under review for approval of the new use for Alimta, said Richard Gaynor, Lilly’s head of oncology. Alimta, which generated $1.15 billion in 2008 revenue, is approved in theU.S. as a first-choice therapy and as a second-line treatment after initial therapy fails.
“We think the concept of maintenance therapy is very exciting, the notion that some kinds of cancer may be a chronic disease,” said John Lechleiter, the chief executive officer of Lilly, in a telephone interview. “It’s exciting to think that there are some kinds of cancer where, while it isn’t eradicated, it might be contained.”
The drug’s use as maintenance therapy got the backing yesterday of a European Medicines Agency panel, Lilly said in a statement.
Overall, the study found patients who were not on a maintenance therapy lived 10.6 months, and Alimta patients survived 13.4 months. Those patients on placebo went 2.6 months without their cancer worsening, while people talking Alimta had 4.3 months before their cancer worsened.
“In lung cancer, these results are very dramatic,” said Richard Gaynor, Lilly’s head of oncology. “This is the first example where maintenance therapy worked really impressively. It’s a paradigm-changing study.”
The study also found that a subset of patients with types of cancer that originated in certain large cells in the lungs lived 5 months longer on Alimta than the comparison group. Patients who had so-called nonsquamous cell cancer survived 15.5 months, and went 4 months without worsening on the Lilly drug. Comparable placebo patients survived 10 months, and went 1.8 months without worsening.
“We can create tremendous value by targeting therapies,” Lechleiter said. “That way the payer doesn’t waste their money and the patient and doctor don’t waste their time.”
Seamus Fernandez, an analyst for Leerink Swann, said Alimta has the potential to generate $1.5 billion in sales this year, and increase to $2.9 billion in 2015.
The impact of the study on Alimta prescriptions may be “limited,” because Alimta is increasingly the first treatment used in cancer, Fernandez wrote in a May 13 note to investors. The study didn’t have Alimta as the first treatment, and additionally, it may be difficult to convince patients to undergo longer chemotherapy cycles, Fernandez wrote.
About 85 to 90 percent of lung cancers are nonsmall cell, according to the American Cancer Society, an advocacy group. Between a quarter and a third of all lung cancers are squamous cell carcinomas, which begin in cells in the lungs that look like fish scales. Patients who had nonsmall cell lung cancers that didn’t start in the squamous cells did best on Alimta maintenance therapy.
Researchers said the most common side effects were fatigue and a disorder of the white blood cells. Other side effects, each found in less than 1 percent of patients, were nausea, vomiting and infection.
UK backs funding for Lilly's Alimta in lung cancer
Wed Aug 5, 2009 7:01pm EDT
Eli Lilly and Company
Drug recommended for subset of lung cancer patients
* NICE decision reverses negative view in April
LONDON, Aug 6 (Reuters) - Britain's healthcare cost-effectiveness watchdog has changed its mind on Eli Lilly's (LLY.N) drug Alimta and now plans to recommend its use within the state health service as a treatment for lung cancer.
The draft guidance from National Institute for Health and Clinical Excellence (NICE) represents a victory for theU.S. drugmaker, since theUK organisation's preliminary view in April was not to back the treatment.
AlthoughBritain is only a minor market for Lilly and other big drugmakers, NICE decisions are closely followed by governments and healthcare insurers worldwide.
NICE said on Thursday it was recommending Alimta in combination with the older chemotherapy drug cisplatin for first-line treatment of locally advanced or metastatic non-small-cell lung cancer, where tumours were an adenocarcinoma or large-cell carcinoma.
The watchdog has a reputation for rejecting some cancer drugs as too expensive, given the limited budget of the National Health Service (NHS). That has prompted some drugmakers to offer special "patient access schemes" to bring down the cost, though no such programme was offered for Alimta.
NICE expects to issue final guidance to the NHS in September 2009.
Alimta, also known as pemetrexed, is already recommended as a treatment asbestos-related cancer, or malignant pleural mesothelioma, in patients who are unsuited to surgery. (Reporting by Ben Hirschler; editing by Karen Foster)
Dual Drug Therapy May Improve Survival Rates in Mesothelioma Cancer Patients
Results of the 30-month study based inMexico City are expected to be released later this year
Syracuse,NY 7/07/2009 02:35 PM GMT (FINDITT)
The National Institute of Cancerologia inMexico City,Mexico will shortly be releasing results of a 30-month study to determine the efficacy of a combination drug therapy designed to improve the response and survival rates of pleural mesothelioma patients undergoing chemotherapy.
The study, which followed 30 pleural mesothelioma patients from September 2007 to April 2009, was conducted to determine whether a combination of two chemotherapy drugs, liposomal doxorubicin and Cisplatin®, would improve survival rates of these patients.
Most single-drug chemotherapy regimes have resulted in response rates of less than 20 percent. Combination therapies, including therapy with non-liposomal doxorubicin and cisplatin, have produced only slight higher response rates of about 25 percent.
Researchers hope the liposomal form of doxorubicin will be more readily absorbed by cancer patients, improving survival rates and helping patients remain comfortable longer. Liposomes are “bubble-like” structures composed of the same material as cell membranes, and are often sued to deliver drugs in certain conditions where normal delivery might result in toxic side effects, or where deeper penetration of the affected cells is required.
Pleural mesothelioma is the most common form of mesothelioma, affecting the lining of the lungs and developing as a result of asbestos exposure. Pleural mesothelioma develops as the tissue which surrounds the lungs becomes embedded with tiny fibers of inhaled asbestos, and can occur decades after initial exposure. The most prevalent mesothelioma causes include direct or indirect workplace exposures. Currently, there is no cure for mesothelioma, although symptoms can be treated to improve comfort in those affected by the condition.
University ofWisconsin Professor Dr. H. Ian Robins, an oncologist who specializes in the treatment of mesothelioma and other cancers, is one of the many US-based physicians who specialize in the study of asbestos-caused cancers. There is no cure for mesothelioma, but many oncologists like Dr. Robins are devoted to the study of this disease and have the hope that a cure is not far off.
Trimodality Therapy May Improve Outcomes of Patients with Pleural Mesothelioma
Researchers involved in a multi-center U.S. trial have reported neoadjuvant chemotherapy with Alimta® (pemetrexed) and Platinol® (cisplatin), followed by pneumonectomy and radiation therapy, may improve survival of patients with Stage I-III pleural malignant mesothelioma. The details of this study appeared in the June 20, 2009 issue of theJournal of Clinical Oncology.
Patients with Stage I-III malignant pleural mesothelioma have cancer limited to one side of the chest. In these cases it may be possible to remove the cancer surgically. However, in Stage III disease, there can be extensive local spread. This spread may include the regional lymph nodes, lungs, and soft tissues, but there is no spread to the opposite lung.
The lack of any single consistently curative treatment modality for patients with Stage I-III malignant pleural mesothelioma has led to the development of multi-modality therapy, which may include surgery, radiation therapy, and/or chemotherapy. Current research suggests that patients in good condition with Stage I-III malignant pleural mesothelioma should be treated with adjuvant chemotherapy and radiation therapy following surgery. However, not all patients will be eligible for multi-modality treatment. Surgery for Stage I-III pleural mesothelioma consists of pleurectomy (decortication) or extrapleual pneumonectomy. Patients with epithelial type Stage I-III pleural mesothelioma treated with surgery and adjuvant chemoradiotherapy have an approximate two-year survival of 60% or more.
The current study evaluated trimodality therapy with neoadjuvant Alimta and Platinol followed by extrapleural pneumonedtomy and adjuvant radiotherapy in 77 patients with Stage I-III malignant pleural mesothelioma. Patients included those with and without positive lymph nodes. Prior to surgery the success rate of delivering four cycles of chemotherapy was 83%. The response rate to chemotherapy was 32.5%, which was determined radiologically. Fifty-seven patients proceeded to surgery, which was completed in 54 patients. Three patients had a pathological CR at the time of surgery. Forty of 44 patients completed radiotherapy. Median survival for the entire group of patients was 17 months. Patients completing all therapy had a two-year survival of 61%. Radiological response to chemotherapy was associated with an improved survival. These authors conclude that this approach produced reasonable long-term survival.
Comments: This trimodality approach to treating patients with Stage I-III pleural mesothelioma produces results similar to those previously reported for the same approach with adjuvant rather than neoadjuvant chemotherapy. It would take a randomize trial to determine if the results of this trial were better than previously reported.
 Krug LM, Pass HI, Rusch VW, et al. Multicenter phase II trial of neoadjuvant pemetrexed plus cisplatin followed by extrapleural pneumonectomy and radiation for malignant pleural mesothelioma.Journal of Clinical Oncology. 2009;27:3007-3013.
New mesothelioma and anti-cancer drugs are constantly being researched and developed. Such drugs are required by the Food and Drug Administration (FDA) to go through extensive clinical trial testing during which their safety and efficacy is monitored.
The patients who choose to participate in these clinical trials typically suffer from a highly advanced type of cancer. Rather than electing to submit to traditional mesothelioma treatments that have proven ineffective in combating the rare asbestos cancer, patients can instead choose from a variety of experimental treatments.
While such experimental treatments are more risk-oriented than traditional treatment modalities, they present cancer patients with a more proactive medium through which to fight to live.
Veglin is a new experimental drug manufactured by VasGene Therapeutics, Inc., Veglin is an anti-angiogenesis drug undergoing clinical trials at theUniversity ofSouthern California's Keck School of Medicine. Veglin inhibits VEGF proteins, halting the formation of blood vessels and limiting the ability of tumors to grow and spread. Veglin is an antisense oligonucleotide, meaning that it can bond to messenger RNA (nucleic acid that directs protein production) and block the production of VEGF proteins.
If Veglin is successful in blocking tumor secretion of VEGF proteins, it is believed that it will be capable of preventing metastasis while simultaneously killing existing cancer cells.
ALIMTA is now available for people with malignant pleural mesothelioma, a cancer usually associated with exposure to asbestos. As of July 9, 2002 the Food and Drug Administration agreed to place ALIMTA in an expanded access program, which gives patients access to an agent that isn't yet commercially available, although the sponsor is actively pursuing marketing approval. Eli Lilly is pursuing approval of ALIMTA in combination with cisplatin for the treatment of malignant pleural mesothelioma, a disease that causes tumors to grow in the linings of the lung, or pleura. Patients live an average of six to nine months following diagnosis. The company said results of a Phase III trial showed that patients treated with ALIMTA and cisplatin combined lived longer and had less pain and shortness of breath, than patients treated with cisplatin alone. In the trial, the most common side effect from cisplatin and ALIMTA was a decrease in infection- fighting white blood cells. Under the expanded access program, ALIMTA will be given free of charge to patients who meet medical eligibility requirements.
L-NDDP (aroplatin) Intrapleural administration is intended to exceed the usefulness of other platinum drugs like Cisplatin that are limited by toxicity and drug resistance.
Endostatin has been shown to inhibit a tumor's ability to grow blood vessels without destroying normal healthy cells. Works with angiostatin. Lovastatin. A cholesterol drug shown to potentially inhibit the growth of cancer cells.
The anti-cancer drug, Interferon Gamma is directly administered into the affected area.
Cisplatinis a platinum-based chemotherapy drug used to treat various types of cancers, including sarcomas, some carcinomas, lymphomas, and germ cell tumors. It was the first member of a class of anti-cancer drugs which now also includes carboplatin and oxaliplatin. These platinum complexes react in vivo, binding to and causing crosslinking of DNA which ultimately triggers apoptosis.
Cisplatin is administered intravenously as short-term infusion in physiological saline for treatment of solid malignacies. The synthesis of cisplatin is a classic in inorganic chemistry. Starting from potassium tetrachloroplatinate(II),K2[PtCl4], the first NH3 ligand is added to any of the four equivalent positions, but the second NH3 could be added cis or trans to the bound ammine ligand. Because Cl- has a larger trans effect than NH3, the second ammine preferentially substitutes trans to a chloride ligand, and therefore cis to the original ammine. The trans effect of the halides follows the order I->Br->Cl-, therefore the synthesis is conducted using [PtI4]2- to ensure high yield and purity of the cis isomer, followed by conversion of the PtI2(NH3)2 into PtCl2(NH3)2, as first described by Dhara.
Innovive, maker of mesothelioma drug, acquired by CytRx
Feb 13, 2009
CytRx Corp. (CYTR), a biopharmaceutical company headquartered inLos Angeles, has completed its acquisition of Innovive Pharmaceuticals Inc. Innovive is the maker of a cancer vaccine that is currently being tested in mesothelioma, lung cancer, leukemia and myelodysplastic syndrome patients. The company also developed the cancer drug tamibarotene and other drug candidates targeting leukemia, sarcoma, breast and lung cancers.
Innovive stockholders received 2.6 million CytRx shares as part of the deal. CytRx could also make as much as $18.3 million in milestone payments, depending on the success or failure of Innovive’s drug candidates.
For the full story, go toForbes.
Lung cancer patients get wonder drug Alimta
Jan 16 2009 by Rob Pattinson, Evening Chronicle
MORE than 120 lung cancer sufferers in the North East are set to benefit from a new treatment.
The North of England Cancer Drug Approvals Group has given the go-ahead to a treatment combination of wonder drug Alimta and chemotherapy treatment cisplatin for a particular type of lung cancer.
Alimta, developed on Tyneside, has helped extend the lives of terminally-ill cancer sufferers, after a Chronicle campaign for it to be funded on the NHS.
Now a new form of the drug will provide an alternative to other forms of treatment where a cancer specialist feels a patient would benefit from the new combination. It will be funded by the local NHS.
Moira Davison, director of the North of England and North Cumbria Cancer Network, said: “We are constantly reviewing the evidence to support new treatments that have not yet been assessed by the National Institute for Health and Clinical Excellence.
“If we feel there is strong evidence to support such treatments we aim to make them available at the earliest opportunity.
“This particular combination for people with non small cell lung cancer will provide great choice of treatments for cancer specialists and patients and is being made available ahead of national guidance.”
Alimta is the only treatment for mesothelioma and was sanctioned for use by North East NHS trusts following the Chronicle’s Give Us A Chance campaign in 2005.
Following two appeals and tireless campaigning by North East patients and families, Nice said all health trusts were free to prescribe the drug.
Asbestos sufferer Arthur Tiffin, 53, ofNorth Walbottle, who died of mesothelioma in June 2007, captured the hearts of the region with his tireless campaigning for the drug.
Thanks to the treatment Mr Tiffin was given an extra two years, during which he attended his son’s wedding and saw the birth of his two grandchildren.
Alimta was developed byNewcastleUniversity’s Prof Hilary Calvert and has been used to help increase life-expectancy of victims, many of whom were exposed to asbestos during their working life.
Prof Calvert, working for the Northern Institute for Cancer Research, looked into Alimta alongside other chemotherapy drugs and trials started in the North East looking at its effectiveness in 2003.
The treatment combined traditional drug Cisplatin with new ingredient Alimta. Some 40-45% of patients had a significant shrinkage in tumours and 70% saw an improvement.
After trials atNewcastle GeneralHospital, Prof Calvert said: “The results have been stunning. We’ve increased life expectancy of people from six to eight months to 13 or 14 months.”
Pemetrexed Shows Promise in Peritoneal Mesothelioma: Presented at ECCO
By Jill Stein
BARCELONA, SPAIN -- September 24, 2007 -- Pemetrexed alone or in tandem with a platinum agent shows good overall response and disease control rates in patients with peritoneal mesothelioma (PM), according to data presented here at the 14th European Cancer Conference (ECCO).
The study enrolled 109 patients with a histologic or cytologic diagnosis of peritoneal mesothelioma that was not amenable to curative surgery and was treated with pemetrexed alone or in combination with a platinum agent.
"Malignant peritoneal mesothelioma is a rare cancer, with a yearly incidence of about one or two cases per million in the US and Europe, while the incidence of pleural mesothelioma is 3- to 30-fold higher in different countries," said study presenter Giacomo Carteni, MD, Director, Oncology Division, Cardarelli Hospital, Naples, Italy.
Few large studies have examined peritoneal mesothelioma, so treatment has largely been based on protocols used in patients with pleural mesothelioma, Dr. Carteni said in his poster presentation on September 24th.
The international Expanded Access Program (EAP) for pemetrexed in mesothelioma provided access to the drug before and during review by regulatory agencies.
In the trial, pemetrexed 500 mg/m2 alone or in combination with cisplatin 75 mg/m2 or carboplatin AUC 5 was given on day 1 of each 21-day treatment cycle as part of the EAP. All patients received standard supplementation with vitamin B12 and folic acid, and dexamethasone for prophylaxis.
Patients were treated until they developed progressive disease or unacceptable toxicity, or until the investigator or patient decided to halt treatment.
Pemetrexed and platinum combination was associated with a 20% or greater response rate and a 76% or greater disease control rate.
Patients in the single-agent platinum group had a 12.5% overall response rate, a 50% disease control rate, and a 41.5% survival rate at 1 year. "This is in line with their worse prognostic factors like higher median age, higher percent of patients who had undergone prior chemotherapy, and lower performance status at baseline," Dr. Carteni said.
Hematologic toxicity was manageable in all groups and in agreement with earlier phase 3 findings, he said.
These results reported for peritoneal mesothelioma are comparable with the pemetrexed EAP in theUS, which involved 98 patients with peritoneal mesothelioma. In that report, the overall response rate was 26% and median survival exceeded 13 months.
The study was sponsored by Eli Lilly and Company.
[Presentation title: Open-Label Study of Pemetrexed (P) Alone or in Combination With a Platinum in Patients With Peritoneal Mesothelioma (PM): Results From the International Expanded Access Program. Abstract P-6571]
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Mesothelioma is an incurableasbestos
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