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Enrolling in a Study? Most Don't Ask Key Questions

May 22, 2004 - NEW YORK (Reuters Health) - A majority of people who enter clinical trials do so without knowing what questions to ask, and many don't understand the risks of study participation, a new survey confirms.

Ten percent of volunteers even said that they did not look at the informed consent form before signing it, according to survey results reported Wednesday by CenterWatch, a Boston-based publisher of clinical trials information.

The findings reinforce the belief that many patients, desperate for a cure, are entering clinical trials without having all the information they need to make a fully informed decision, CenterWatch noted.

It underscores "that volunteers need to become their own advocates and obtain more information before participating in a clinical trial," said Kenneth Getz, CEO of CenterWatch.

The survey, conducted in January and February of this year, involved 1,600 volunteers who had completed phase I, II or III clinical trials within the previous 6 months. In phase I trials, researchers are typically trying to determine if a treatment is safe, while later trials are designed to determine if the treatment actually works.

The findings suggest that volunteers may be giving their consent to participate in a trial without really understanding what they are getting into. Seventy percent didn't know what to ask at the outset of a trial, and 30% didn't understand that the study could carry additional risks.

Surprisingly, only 28% felt their overall experience would have been better if they had more discussions with study staff as part of the informed consent process.

"That 28% is a disappointingly low number given the 70% that said they knew very little or nothing coming into the informed consent process," Getz told Reuters Health.

Getz believes that patients are often "reluctant or anxious about asking too many questions." That's particularly true of senior citizens who are more trusting of research professionals and don't want to appear to be confrontational. Often, individuals are so scared and confused that they fear asking questions might delay their enrollment in a study, he added.

Patients' lack of true informed consent is troubling because it can raise their personal risk and the overall outcome of the trial, CenterWatch suggested. The company estimates that one out of 30 volunteers will experience a serious side effect and one in 10,000 will die.

On a positive note, the survey found that patients do have a clearer understanding of some aspects of the trial. Most understood the duration of the trial (85%), the number of visits required (84%), and the fact that they could terminate participation at any time (89%).

CenterWatch recently published a 300-page consumer guide describing the risks and benefits of volunteering for clinical trials. Copies of "Informed Consent: The Consumer's Guide to the Risks and Benefits of Volunteering for Clinical Trials" are available for purchase through www.centerwatch.com.

Separately, the American Association of Health Plans commissioned ECRI, an independent nonprofit research organization, to produce a patient reference guide and companion summary intended to demystify the clinical trials process. "Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness," may be downloaded for free at www.ecri.org and www.aahp.org.

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Callisto Pharmaceuticals Granted Orphan Drug Designation for Annamycin to Treat Acute Lymphoblastic Leukemia

Orphan Drug Status Provides Callisto with Seven Years Market Exclusivity in United States

NEW YORK, NY -- (MARKET WIRE) -- 06/24/2005 -- Callisto Pharmaceuticals, Inc. (AMEX: KAL), a biopharmaceutical company primarily focused on the development of drugs to treat cancer, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate Annamycin for the treatment of acute lymphoblastic leukemia (ALL). Annamycin, a second-generation anthracycline developed at M.D. Anderson Cancer Center, is being developed by Callisto to treat relapsed acute leukemia patients. Callisto plans to begin a clinical trial in adult relapsed acute lymphoblastic leukemia patients in the near future.

"This marks an important step for Callisto's Annamycin program," commented Callisto Chief Executive Officer Dr. Gary S. Jacob. "Callisto is planning an ambitious program of clinical development of Annamycin starting this year, and the designation of orphan drug status to treat ALL gives additional assurance to both the company and our investors that we are well protected against any potential competition."

About Orphan Drug Designation

The Orphan Drug Act is intended to encourage development of products for rare diseases affecting fewer than 200,000 people in the United States. Orphan drug designation, along with approval by the FDA for commercialization of Annamycin, entitles Callisto to seven years of market exclusivity in the United States, provided Callisto continues to meet certain conditions established by the FDA. During the seven-year exclusivity period, the FDA will not accept or approve other applications to market the same medicinal product for the same therapeutic indication.

For products designated as orphan drugs, the FDA not only provides market protection for the developing company, but also provides certain tax credits, eligibility for research grants and protocol assistance, opportunities for regulatory agency assistance on review of clinical protocols, and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee.

About Annamycin

Annamycin, a drug from the anthracycline family, earlier completed a Phase I/IIa trial in refractory leukemia patients. The drug was developed at the M.D. Anderson Cancer Center to address limitations associated with other anthracyclines. Annamycin circumvents multiple drug resistance, shows decreased cardiotoxicity, and achieves greater than 95 percent incorporation into liposomes, providing a favorable means of drug administration.

About Callisto Pharmaceuticals, Inc.

Callisto is a biopharmaceutical company focused on the development of drugs to treat cancer. Callisto has two lead drugs in clinical development, Annamycin to treat relapsed leukemia, and Atiprimod to treat relapsed multiple myeloma. Callisto intends to initiate a clinical trial of Annamycin in relapsed acute lymphoblastic leukemia patients in mid 2005. Annamycin, a drug from the anthracycline family, has a novel therapeutic profile, including activity against drug resistant tumors and significantly reduced cardiotoxicity.

Callisto's second drug, Atiprimod, is in a Phase I/IIa clinical trial in relapsed multiple myeloma patients, and is a small-molecule, orally available drug with antiproliferative and antiangiogenic activity. Callisto also has drugs in preclinical development for melanoma, gastrointestinal inflammation, and a program focused on the development of a drug to protect against staphylococcus and streptococcus biowarfare agents. Callisto has exclusive worldwide licenses from AnorMED Inc. and M.D. Anderson Cancer Center to develop, manufacture, use and sell Atiprimod and Annamycin, respectively. For additional information, visit 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, 2004, 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.
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Investor Relations:
Marty Tullio
McCloud Communications, LLC
949.553.9748
Email Contact

Company Contact:
Dan D'Agostino
Callisto Pharmaceuticals, Inc.
212.297.0010 x227
Email Contact

SOURCE: Callisto Pharmaceuticals, Inc.

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