Leukemia Cancer News
Scientists find means to detect cheaper blood cancer:
[Health India]: Kolkata, Nov 7 : Scientists here have claimed to have discovered a new means of detecting Leukemia (or blood cancer) in children with the help of giant African snail, an agricultural pest.
The discovery made by researchers at the Indian Institute of Chemical Biology (IICB) in Kolkata can bring down the cost of cancer detection and treatment significantly.
Suchanda Choudhary, a junior research fellow at IICB, said that the new method would not only help in cancer detection in children but would also reduce the expenses. "In normal cancer diagnosis we have a problem that the antibodies that are used for this diagnosis are very expensive. So, each time the patient has to go for diagnosis, the entire procedure is very expensive. So, like once our system is established we offer to help cheaper treatment. The cell surface antigens are kind of changed as a result of cancer and our probe which is isolated from this African giant snail, will help in detecting this new surface antigens that are being expressed on the Leukemic cells. That way our process is going to be cheaper once it is established," said Choudhury.
This gives easy identification not only to the presence of cancer cells, but also to the spread of the cancer cells in the body. "Those children if we take their blood or if we take their cancer cell this particular lectin which we purified from the snail it has an ability to bind, to locate, to kind of identify this particular cancer cell amongst all other cells. So, thereby we have developed a method or a procedure by which, utilising this lectin we could detect the cancer cell in children," Chitra Mondal, Senior Assistant Director at IICB said.
The Giant African Snails are abundantly available across India, particularly in the coastal regions and the Lectin taken from its blood is relatively cheaper than any of the current panel of antibodies used for cancer detection in children.
It can also prevent overdose of chemotherapy during cancer treatment because monitoring of the level of cancer cells is much easier and less expensive through this process. Till now, most premier laboratories lack the facility for conducting immunophenotype, the process for preliminary investigation of the disease, because of the high cost of imported antibodies.
The degree of the disease, termed Minimal Residual Disease, following chemotherapy, is determined on the basis of assumption made by the oncologists. The discovery of the Blue Blood Lectin would go a long way in bringing cheaper precision to the treatment of blood cancer in children.
Leukemia
From OncologyChannel
Overview
Leukemia is a form of cancer that begins in the blood-forming cells of the bone marrow - soft, inner part of the bones. Leukemia - which literally means "white blood" in Greek - occurs when there is an excess of abnormal white blood cells in the blood. Known as leukocytes, these cells are so plentiful in some individuals that the blood actually has a whitish tinge.
Under normal circumstances, the blood-forming, or hematopoietic, cells of the bone marrow make leukocytes to defend the body against infectious organisms such as viruses and bacteria. But if some leukocytes are damaged and remain in an immature form, they become poor infection fighters that multiply excessively and do not die off as they should.
The leukemic cells accumulate and lessen the production of oxygen-carrying red blood cells (eythrocytes), blood-clotting cells (platelets), and normal leukocytes. If untreated, the surplus leukemic cells overwhelm the bone marrow, enter the bloodstream, and eventually invade other parts of the body, such as the lymph nodes, spleen, liver, and central nervous system (brain, spinal cord). In this way, the behavior of leukemia is different than that of other cancers, which usually begin in major organs and ultimately spread to the bone marrow.
There are more than a dozen varieties of leukemia, but the following four types are the most common:
acute lymphocytic leukemia (ALL),
acute myelogenous leukemia (AML),
chronic lymphocytic leukemia (CLL), and
chronic myelogenous leukemia (CML).
Acute leukemias usually develop suddenly, whereas some chronic varieties may exist for years before they are diagnosed.
Leukemia Facts & Figures
Leukemia often is thought to be a childhood disease. In fact, leukemia strikes 10 times as many adults as children. The American Cancer Society (ACS) predicts that about 30,200 new leukemia cases - 27,900 adults and 2,300 children - will be diagnosed in the United States during 1999. Acute myelogenous leukemia (AML) is the most frequently reported form of leukemia in adults, and approximately 10,100 new cases are anticipated in 1999.
About 41% of the 30,200 latest cases will have chronic leukemia - an estimated 7,800 chronic lymphocytic leukemia (CLL) cases and 4,500 chronic myelogenous leukemia (CML) cases. In addition, hairy cell leukemia (HCL), a slow-growing lymphocytic cancer, will account for about 604 cases (2% of all leukemias). Sadly, it is estimated that approximately 22,100 American adults and children will die of leukemia in 1999.
Acute myelogenous leukemia (AML) is the most common adult form of leukemia, affecting nearly 5 in every 100,000 men each year.
Chronic leukemia, like many other cancers, is a "disease of old age." The average age of individuals with chronic lymphocytic leukemia (CLL) is roughly 70 years, and the average age of chronic myelogenous leukemia (CML) patients is 40 to 50 years. By contrast, acute lymphocytic leukemia (ALL) is largely a pediatric disease, usually appearing in children who are under 10 years of age.
In general, leukemia affects more men than women throughout the world, although the male:female ratio is highest in CLL patients in Western countries.
New Version of Leukemia Drug Better
Delivery Allows Medication to Stay in Body Longer
As many as one-third of patients with a rare form of acute myelogenous leukemia (AML) have the possibility of a long-term, disease-free future without traditional chemotherapy using Lipo-ATRA, a new form of the drug ATRA, according to a recent study.
In the small Phase II trial, patients with acute promyelocytic leukemia (APL) were found to be disease-free for more than five years using Lipo-ATRA, says the studys principal investigator Elihu Estey, M.D., professor in the M. D. Anderson Department of Leukemia.
Lipo-ATRA consists of ATRA (all-trans retinoic acid) wrapped inside fat bubbles. Lipo-ATRA is delivered intravenously so that it can remain in the body longer to create a remission longer than if ATRA were taken orally. Traditional treatment of APL combines ATRA with the chemotherapy drug idarubicin. Now, Lipo-ATRA has been found to be effective on its own, Estey says.
This is the first time we have seen patients with an acute leukemia potentially cured without the use of traditional chemotherapy, Estey says. Thats an important development in the field of leukemia because traditional treatment with chemotherapy often produces side effects, even death, in patients with different kinds of leukemia than the one studied here.
Long-term remission found without chemotherapy
In the trial, patients received Lipo-ATRA for three months and then continued to receive Lipo-ATRA without the chemotherapy drug idarubicin, as long as their bone marrow showed no evidence of APL. If APL was still present, idarubicin was added.
Of the 34 patients who received Lipo-ATRA:
- 10 remain in remission for an average of five years, despite never receiving chemotherapy
- Many of the patients who needed idarubicin also remain in remission
Fat bubbles deliver drug more effectively
Oral ATRA eradicates APL in most patients when combined with idarubicin, Estey says, but the disease often returns. The tendency for remissions induced by ATRA to be brief was originally thought to reflect the fact that little of the drug remains in the body over long periods of time. To find a solution, a team headed by Gabriel Lopez-Berestein, M.D., professor in the Department of Experimental Therapeutics, developed the new form of ATRA, which is a more effective way to deliver ATRA.
Because Lipo-ATRA can be given intravenously it stays in the plasma longer, so the idea was perhaps you could prevent the relapses with Lipo-ATRA, Estey says. In fact, one-third of patients in the trial were rid of the disease, whereas that probably would not have happened with oral ATRA. Lipo-ATRA is a better drug than ATRA. Today no one takes oral ATRA by itself. Whether Lipo-ATRAs superiority to ATRA is solely due to the higher blood levels in unknown, but the important observation is that it is a better drug.
The down side of the Lipo-ATRA treatment is that it is inconvenient. Patients need the treatments several times a week for nine months.
Since Lipo-ATRA isnt readily available, Estey and his colleagues in the Department of Leukemia have followed up with a study that pairs ATRA with arsenic trioxide. After one year, this drug combination is showing similar promise to the Lipo-ATRA therapy. But more follow-up study is needed to know the long-term benefits, Estey says.
Contact: Mary Lawson [email protected]
612-624-6165 University of Minnesota
5-Nov-2004
Obesity linked to another cancer - leukemia in older women
University of Minnesota cancer researcher says shedding excess pounds may be key in preventing often fatal disease A study from the University of Minnesota Cancer Center indicates that overweight and obesity could more than double an older woman's risk of acute myelogenous leukemia (AML), an often fatal cancer of the bone marrow and blood.
The results of the study are published in the November issue of Cancer Epidemiology, Biomarkers and Prevention journal.
Other studies have shown overweight and obesity are risk factors for colon, breast, kidney and endometrial cancers. This study, sponsored by the National Cancer Institute, examined the potential link between obesity and risk of leukemia. Over 14 years, the health of more than 37,000 older Iowa women was monitored; 200 of the women developed leukemia 74 were diagnosed with AML and 88 with chronic lymphocytic leukemia (CLL).
"We found that the risk for getting AML was 90 percent higher in overweight women age 55 and older who had a body mass index (BMI*) of 25-29," says Julie Ross, Ph.D., associate professor of pediatrics at the University of Minnesota Medical School. She also is an epidemiologist at the University of Minnesota Cancer Center and the lead researcher on this study. "In obese women age 55 and older and with a BMI of 30 or greater, the risk increased to as much as a 140 percent."
The study found little evidence of an association between overweight and obesity with CLL.
AML is cancer that starts in the bone marrow in immature cells that normally should become white blood cells. Acute means the leukemia develops quickly.
According to the American Cancer Society, about 33,400 new cases of leukemia will be diagnosed in the United Sates this year. About half of those cases will be acute leukemias. AML is the most common acute leukemia with about 11,900 patients diagnosed annually; 90 percent of them adults age 65 and older. About 8,870 people with AML will die this year. The 5-year survival rate for middle-aged people is about 12 percent and 3 percent for elderly adults.
While incidence rates for some adult leukemias, such as CLL and chronic myeloid leukemia, are declining in the United States, AML in people over age 65 has increased about 10 percent in the last 25 years.
"The fact that survival rates for AML are extremely poor for older individuals makes identifying people who are at increased risk for this cancer of public health importance," Ross says. "Given that about 65 percent of adults in the United States are overweight or obese, the projection we can make from our study is that about 30 percent of AML in older adult women could be due to being overweight or obese."
This study is part of the Iowa Women's Health Study. In 1986, over 40,000 women between the ages of 55 and 69 years completed a lifestyle and health questionnaire that included current height and weight. This study followed more than 37,000 of these women who, with the possible exception of skin cancer, were cancer-free at the beginning of the study.
"The risk of AML was increased among women who reported being overweight or obese compared with women of normal weight," Ross says. We don't know why higher BMI would be associated with leukemia, particularly AML. A possible explanation could be an alteration in hormones linked with obesity."
She adds that while it can't be said with research certainty, "it would seem that as with other cancers linked to obesity, reducing excess pounds and maintaining normal weight would be important in preventing AML."
Ross says a limitation of her study was that only postmenopausal, mostly white, women participated. She also says BMI was calculated using weight and height reported by each participant, which could be subject to some degree of imprecision. However, she notes, BMI is the standard for population-based studies.
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The Cancer Center at the University of Minnesota is a National Cancer Institute-designated Comprehensive Cancer Center. The Cancer Center conducts cancer research that advances knowledge and enhances care. The center also engages community outreach and public education efforts addressing cancer. To learn more about cancer, visit the University of Minnesota Cancer Center Web site at http://www.cancer.umn.edu. For cancer questions, call the Cancer Center information line at 1-888-CANCER MN (1-888-226-2376).
* BMI is the measure of body fat based on height and weight; it is the standard used for population-based research studies on obesity. As an example, a 5'4" woman would be considered overweight if she weighed between 146 and 174 pounds, and obese if she weighed 175 pounds or more. To calculate body mass index, visit the National Institutes of Health at http://nhlbisupport.com/bmi/bmicalc.htm.
Herb undermines cancer drug
By MARY COCHRANE
The herbal supplement St. John's Wort has been shown to undermine the effectiveness of a newer, revolutionary anticancer medication, according to a study by UB researchers.
The study, forthcoming in the November issue of the journal Pharmacotherapy, is the first to show that St. John's Wort may compromise the effectiveness of Gleevec® (imatinib mesylate, Novartis, Inc.), a blockbuster anticancer drug that has revolutionized the treatment of chronic leukemia, according to Patrick F. Smith, assistant professor in the School of Pharmacy and Pharmaceutical Sciences.
The study is especially timely because recent surveys show that the use of alternative supplements such as St. John's Wort has increased tremendously over the past decade, particularly among cancer patients, Smith said. Approximately one-third to one-half of all cancer patients use some type of alternative supplement, such as vitamins and herbal products, according to the study.
"We found that St. John's Wort may significantly reduce the effect of Gleevec® by lowering blood levels to the point where patients may fail therapy if they take both together," Smith said.
"Patients may not view alternative products as 'medications,' and thus they frequently go unreported to the patient's physician or pharmacist," Smith said. "For the most part, patients often times don't necessarily need these herbal products, and don't know that there may be serious drug interactions."
Gleevec®, or imatinib mesylate, was the first drug to specifically target cancer cells without targeting normal cells, making it relatively non-toxic, unlike traditional chemotherapy drugs. And it's easier to take: while chemotherapy is administered intravenously every few weeks for several dosing cycles, Gleevec® is taken in a daily, oral dose over the course of years.
"Hence, it is the first drug that turns cancer into a chronic disease that is treated with a tablet, similar to high blood pressure or diabetes," Smith said.
As a result, Gleevac® received an expedited approval in the United States for the treatment of chronic myeloid leukemia (CML) and rapidly has become a cornerstone of cancer treatment, according to Smith.
Taking St. John's Wort, commonly used for mood elevation in cancer patients, along with Gleevec® "will unnecessarily put patients at risk for failure and resistance during treatment," Smith said. That's because the St. John's Wort increases a patient's metabolism of the medication, resulting in the drug's being eliminated more quickly than normal from the body. This lowers the blood levels, or reduces the patient's exposure to the medication, decreasing its effectiveness.
"Thus, the reduction in blood levels caused by St. John's Wort may cause Gleevec® to be less effective, resulting in treatment failure. The other thing that can happen is that, if blood levels are too low, the leukemia cells also can become resistant to Gleevec®, rendering it completely ineffective, even if the dose is increased," Smith explained.
Similar results have been described in drug-interaction studies of St. John's Wort with medications for AIDS, said Smith, who added that he believes cancer patients should avoid herbal supplements in general during treatment.
"We need to do a better job of educating both physicians, as well as the public, regarding the hazards of taking these herbal products, which are unregulated by the FDA," Smith said.
"It is imperative that patients know that herbals are not regulated and that they may be very dangerous when combined with certain drugs. Patients should always check with their physician or pharmacist before taking any herbal or over-the-counter product. Their lives literally may depend on it."
Research And Markets: Comprehensive Coverages Of The R&D Trends To Set The Future Leukemia Marketplace.
DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 3, 2004--Leukemia includes a broad variety of histological separate disorders. This make the leukemia market segmented. And even though a high level of unmet medical need, together with its dependence on chemotherapy, leukemia has not historically been the focus of significant R&D investment for emerging drugs in the pharmaceutical industry.
Research and Markets (http://www.researchandmarkets.com/reports/c8479) has announced the addition of Competition on the Future Leukemia Markets to their offering
This has now clearly changed with the launch of Novartis' second-line therapy Gleevec (imatinib mesylate) for chronic myeloid leukemia (CML), presenting the industry with proof that development within the leukemia market produces lucrative returns. Gleevec saw sales rise 47 percent to $757 million in the first half 2004. Consequently, the historical general conception that relatively low prevalence diseases, has been insufficient in size to allow companies to quickly regain their investment is clearly out of date. In this perspective enhanced development is expected. Additional progress in disease molecular pathology, and research into the possible significance of innovative predictive markers will offer physicians with supplementary information with which to compose future treatment strategies.
To enable people to update their knowledge status at the same time receive a basic foundation, this report "Competition on the Future Leukemia Markets" describes and analyzes the latest year of progress in four different market segments; CLL, CML ALL and AML. In this report, we provide one of the most comprehensive coverages of the R&D trends to set the future leukemia marketplace. This report presents both an overview and a detailed description on the progress of key drugs in Phase III and II development, together with general descriptions of drugs and targets. There are 35 drug candidates identified in phase II or III stage of development. Among these drugs it can clearly be seen that there is substantial progress while others have failed. There will soon be a harder competition in several of the leukemic sub-markets and current treatments will be changed for the benefit of more innovative therapies.
The information structure in this cancer highlight reports will as well provide an easy reading format to track B2B collaborations and industry academic relationships.
Therapeutic candidates included in this analysis: AG-858, AP23573, Avastin, Atragen, BAY 43-9006, Bryostatin-1, Campath, Ceplene, CEP-701, Clofarabine, Cloretazine, Decitabine, FK228, Flavopiridol, Genasense, Gleevec, GVAX, Mylotarg, Multiferon, OSI-461, Phenoxodiol, pentostatin, PEG-Interferon, PKC412, PTK787, Revlimid, Rituxan, SU5416, SCH 54031, Sarasar, Triapine, Tezacitabine, Troxacitabine, Trisenox, valspodar, Velcade, Zamyl, Zarnestra, Xcytrin, XL999
For more information visit http://www.researchandmarkets.com/reports/c8479
Contacts
Research and Markets
Laura Wood
[email protected]
Fax: +353 1 4100 980
Bayer and Onyx Announce Results of Phase I Studies
Evaluating BAY 43-9006 in Combination with Conventional Chemotherapy Drugs
WEST HAVEN, Conn. and RICHMOND, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) announced results from several Phase I clinical trials of BAY 43-9006 administered in combination with conventional chemotherapy drugs in patients with various tumor types including, hepatic cancer and colorectal cancer. The data were presented at the 29th European Society of Medical Oncology (ESMO) meeting in Vienna, Austria.
Data from these Phase I safety and pharmacokinetic (metabolism) interaction studies showed that BAY 43-9006 could be combined with the other anticancer agents evaluated (doxorubicin, oxaliplatin, fluorouracil and leucovorin). In addition, data show that BAY 43-9006 required no dose adjustment when administered with ketoconazole (CYP3A inhibitor). Safety data generated across all studies showed no unexpected treatment-related adverse events.
BAY 43-9006, a novel RAF kinase and VEGFR inhibitor under investigation for the treatment of different types of cancer, combines two anticancer activities: inhibition of tumor cell proliferation and angiogenesis (the growth of new blood vessels).
BAY 43-9006 ESMO Data
BAY 43-9006 data being presented at this year's ESMO meeting include:
-- Results of a Phase I trial of BAY 43-9006 in combination with doxorubicin in patients with primary hepatic cancer. H. Richly, MD.
-- Results of a Phase I combination trial of BAY 43-9006 with oxaliplatin in patients with colorectal cancer. P. Kupsch, MD.
-- Phase I trial of BAY 43-9006 in combination with 5-fluorouracil (5-FU) and leucovorin (LCV) in patients with advanced refractory solid tumors. A. Figer, MD.
-- A randomized Phase I clinical and biologic study of two schedules of the C-RAF kinase inhibitor BAY 43-9006 in patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML): A NCI Canada Clinical Trials Group study. M. Crump, MD.
-- Lack of effect of ketoconazole, a CYP3A inhibitor, on BAY 43-9006 clinical pharmacokinetics. C.D. Lathia, Ph. D.
About BAY 43-9006
BAY 43-9006, a novel investigational drug candidate, has demonstrated anti-proliferative and anti-angiogenic properties -- two important anticancer activities. In preclinical models, BAY 43-9006 inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the level of RAF kinase. BAY 43-9006 also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signaling cascades.
BAY 43-9006 is currently undergoing Phase III evaluation for the treatment of advanced kidney cancer and Bayer and Onyx intend to initiate additional Phase II and Phase III trials in other tumor types. For more information on BAY 43-9006 clinical trials, visit http://www.clinicaltrials.gov .
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including BAY 43-9006 with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at: http://www.onyx-pharm.com .
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation ( http://www.bayerpharma.com ) is part of the worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG.
Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. About 34,600 people are employed by Bayer HealthCare worldwide.
Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well being and quality of life by diagnosing, preventing and treating disease.
Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes and commercialization efforts of BAY 43-9006. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made Onyx's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2004 under the heading "Additional Business Risks" and
Onyx's subsequent Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release except as required by law.
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Source: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.
SuperGen and MGI PHARMA Announce Submission of Dacogen NDA to U.S. FDA
DUBLIN, Calif. & MINNEAPOLIS--(BUSINESS WIRE)--Nov. 1, 2004--SuperGen, Inc. (Nasdaq:SUPG) and MGI PHARMA, INC. (Nasdaq:MOGN), today announced that the full New Drug Application (NDA) seeking approval of Dacogen(TM) (decitabine) for injection has been submitted to the U.S. Food and Drug Administration (FDA) for its review. Dacogen is an investigational anti-cancer therapeutic for the treatment of patients with myelodysplastic syndromes or MDS. MGI PHARMA has exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen.
"SuperGen is delighted to achieve this key U.S. regulatory milestone for Dacogen," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "Thanks to the valuable assistance from our partner MGI PHARMA and the diligent efforts of the entire SuperGen team, we completed our submission of the Dacogen NDA early in the fourth quarter. We look forward to FDA's response, and we remain committed to bringing Dacogen to patients as quickly as possible."
"Given today's announcement and the recently announced acceptance for review of the Marketing Authorization Application (MAA) for Dacogen by the European Medicines Agency (EMEA), we look forward to working closely with SuperGen and the regulatory authorities in both the U.S. and Europe throughout the review processes," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA.
SuperGen completed Phase III clinical trials of Dacogen in patients with MDS in March 2004. SuperGen and MGI PHARMA are collaborating on the regulatory development process for Dacogen in MDS. MGI PHARMA plans to initiate a Phase III trial of Dacogen for the treatment of acute myelogenous leukemia (AML) in early 2005 and plans to evaluate Dacogen for further development in other hematologic malignancies. Alternative dosing schedules for Dacogen, including subcutaneous administration and other intravenous infusion regimens, are currently being evaluated in clinical studies.
About Dacogen
Dacogen is an investigational drug. It has not yet been approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. In clinical trials, Dacogen has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors. Dacogen belongs to a class of drugs called hypomethylating agents, with a unique mechanism of action. Methylation is a process in which methyl (CH3) groups are added to DNA, which may inactivate or "silence" tumor suppressor genes.
About MDS
MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukemia. According to the Aplastic Anemia and MDS International Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS are diagnosed annually in the United States. The number of new cases diagnosed each year is increasing. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease.
About SuperGen
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. SuperGen's product portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer; Nipent(R) (pentostatin for injection); Mitomycin; and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit http://www.supergen.com.
About MGI PHARMA
MGI PHARMA, INC. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection, KADIAN(R) (sustained release morphine capsules), Salagen(R) Tablets (pilocarpine hydrochloride) and Hexalen(R) (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with partners in international markets. For more information about MGI PHARMA, please visit http://www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions, and include statements regarding the timing of the submission of an NDA for Dacogen to the U.S. Food and Drug Administration. These forward-looking statements are not guarantees of MGI PHARMA's or SuperGen's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause either company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether acceptance of the NDA submission for regulatory approval for Dacogen will be made in the U.S. in a timely fashion, if at all; whether the drug will be timely approved, if at all in any country where a submission is made; whether the drug, if approved will be successfully commercialized; continued sales of MGI PHARMA's or SuperGen's other marketed products; development or acquisition of additional products; reliance on contract manufacturing and third party suppliers; changes in strategic alliances; and other risks and uncertainties detailed from time to time in either company's filings with the Securities and Exchange Commission, including their most recently filed Forms 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty to update any of these forward- looking statements to conform them to actual results.
Contacts
MGI PHARMA (Investors)
Jennifer Davis, 212-697-1976
E-mail: [email protected]
or
MGI PHARMA (Media)
David Melin, 952-346-4749
E-mail: [email protected]
or
SuperGen, Inc.
Timothy L. Enns, 925-560-0100 x111
E-mail: [email protected]
or
Euro RSCG Life NRP
Sharon Weinstein, 212-845-4271
E-mail: [email protected]
The Future Of Leukemia Treatment
BACKGROUND: Researchers say about 500 children are diagnosed with acute myeloid leukemia (AML) each year. Acute promyelocytic leukemia, or APL, is a subtype of AML.
It accounts for about 1 percent of all childhood leukemia cases. The disease is characterized by an abnormal form of white blood cells. These abnormal blood cells in the bone marrow and peripheral blood replace normal blood cells.
APL is most often found in children between ages 2 and 3, and in adults over age 40. However, it has also been found in older children and teenagers. APL is more common among children of Hispanic and Mediterranean origin.
Early diagnosis of APL is important because patients may develop serious blood-clotting or bleeding problems. This can usually be prevented or treated by giving patients blood thinner medications. Other treatments might include transfusions of platelets or other blood products. With modern therapies, bleeding is often less of a problem once treatment of APL begins.
STANDARD TREATMENT: Standard treatment for APL patients includes chemotherapy along with an oral form of vitamin A known as ATRA. With this treatment, about 75 percent to 80 percent of APL patients are expected to survive. Side effects of the combined treatment include breathing problems due to lung fluid buildup, low blood pressure, kidney damage and severe fluid retention.
A CHEMO-FREE ALTERNATIVE: Researchers from the M.D. Anderson Cancer Center in Houston are studying a new, chemotherapy-free alternative for patients with APL. The treatment uses a form of ATRA, known as lipoATRA. LipoATRA is simply ATRA wrapped in fat and injected. Researchers tested the therapy on 34 patients. It won't work for everyone, but results show lipoATRA kept 10 of the 34 patients in remission for several years without having to undergo chemotherapy. The remaining patients who did not respond as well to the lipoATRA treatment had to undergo chemotherapy. There are still side effects with lipoATRA and they may not be any better than side effects seen with chemotherapy.
The treatment is not yet approved by the FDA, and researchers say it does not offer any practical benefits at this time for patients with APL. However, they say their study is significant because it demonstrates how leukemia will be treated in the future. Dr. Elihu Estey from the M.D. Anderson Cancer Center said, "It's, I think, probably the first demonstration in the field of leukemia that you can cure patients without giving them chemotherapy. It's plausible to defer chemotherapy and still wind up okay."
FOR MORE INFORMATION, PLEASE CONTACT:
Elihu Estey, M.D.
The University of Texas
M.D. Anderson Cancer Center
1515 Holcombe Blvd.
Unit 428
Houston, TX 77030-4009
[email protected]
For other medical research, visit Ivanhoe Broadcast News on the Internet at http://www.ivanhoe.com
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