Technique to Preserve Fertility in Young Women May Be Unsafe for Patients With Leukemia

/PRNewswire/ -- Although the use of ovarian tissue cryopreservation and transplantation has lead to 13 live births in women with lymphoma or solid tumors, this method of fertility preservation may be unsafe for patients with leukemia, according to a recent study published online in Blood, the journal of the American Society of Hematology. The method involves removing and freezing ovarian tissue before the patient undergoes aggressive chemotherapy and radiotherapy, and then reimplanting the tissue once the cancer has been brought under control. One major concern with leukemia patients is the risk that their frozen-thawed ovarian tissue might harbor malignant cells that could induce a recurrence of the disease after reimplantation.

"Our study provides clear evidence that cancer cells in women with acute and chronic leukemias can contaminate the ovaries," said Marie-Madeleine Dolmans, MD, professor at the Universite Catholique de Louvain in Brussels and lead author of the study. "If this tissue is reimplanted in these women when they're ready to have children, there's a good possibility that the cancer will come back."

As most acute lymphoblastic leukemia (ALL) patients are diagnosed with the disease at a young age, consideration of the preservation of their fertility is especially important. In fact, according to the National Cancer Institute, 71 percent of those diagnosed with ALL are less than 35 years old, as are nearly 10 percent of those with chronic myelogenous leukemia (CML)(1). In 2010, it is estimated that 2,180 women will be diagnosed with ALL and 2,070 with CML(1).

As aggressive chemotherapy and radiotherapy are damaging to the reproductive organs, the researchers wanted to examine the safety of using ovarian tissue cryopreservation to safeguard the fertility of patients with leukemia. In this study, researchers examined the implications of the technique in 12 women with ALL, a fast-growing cancer of the white blood cells, and six women with CML, a slowly progressing bone marrow cancer. The 18 patients included in this study were between 2 and 31 years of age when their ovarian tissue was cryopreserved (from 1999 to 2008). The mean age of the patients with ALL was 14.5 years and 24.7 years for those with CML.

Although initial microscopic examination did not reveal any cancerous cells in the ovarian tissue samples collected from each patient, by using a technique called real-time quantitative polymerase chain reaction (RT-qPCR), the scientists found cancerous cells in the ovarian tissue of 70 percent of the ALL patients and 33 percent of the CML patients. For further analysis, the researchers engrafted the ovarian tissue samples into 18 healthy mice for an observational period of six months. In the mice who received tissue from CML patients, the grafts looked normal and did not appear to contain any cancerous cells. In contrast, four of the mice who received ovarian tissue from ALL patients developed tumors. Through use of RT-qPCR and the mouse model, the researchers demonstrated the viability and malignant potential of leukemic cells present in the frozen ovarian tissue, especially from ALL patients.

"Given our findings, further research is needed to develop safer options for fertility preservation in patients with acute and chronic leukemias," said Jacques Donnez, MD, professor at the Universite Catholique de Louvain in Brussels and co-author of the study.

"Leukemia patients can benefit from fertility preservation techniques," added Brandon Hayes-Lattin, MD, the Director of the Adolescent and Young Adult Center at the Knight Cancer Institute in Portland, Oregon. "But the strategies offered must be both effective and safe. Among its other strengths, this work emphasizes that molecular methods can be successfully applied to assessments of safety."

(1) National Cancer Institute. SEER Stat Fact Sheets. Available at: http://seer.cancer.gov/statfacts.

The American Society of Hematology is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology. ASH provides Blood: The Vital Connection, a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. The official journal of ASH is Blood, the most cited peer-reviewed publication in the field, which is available weekly in print and online.

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FDA Grants Orphan Drug Status for Personalized Cancer Vaccine, BiovaxID®, Targeting Mantle Cell Lymphoma

(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: “BVTI”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

With FDA Orphan Drug Status granted for this second indication, Biovest gains seven-years of market exclusivity for BiovaxID upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

According to Biovest’s Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, “Orphan Drug Designation is an important step in our regulatory strategy. With promising clinical trials now complete in both follicular lymphoma and mantle cell lymphoma, we are preparing to seek regulatory approvals for BiovaxID in two separate indications. In addition to our ongoing regulatory efforts with regard to follicular lymphoma, we look forward to formally presenting our mantle cell Phase II clinical trial results to the FDA, and potentially the EMEA, later this year, as we explore potential expedited market registration pathways to offer this therapeutic vaccine regimen as a new treatment option for mantle cell patients.”

In the BiovaxID mantle cell lymphoma Phase II study, tumor-specific immune responses were observed in 87% of the patients vaccinated with BiovaxID following rituximab-containing chemotherapy (EPOCH-R). Consistent with all other BiovaxID studies, the vaccine was very well tolerated and safe.

Biovest’s President, Samuel S. Duffey added, “As we prepare to exit reorganization as a fully restructured public company, we remain firmly committed to our goal to bring needed new therapies to patients suffering with lymphoma. I am pleased that we received Orphan Designation for mantle cell lymphoma, and I am excited about our opportunity to potentially advance the role of personalized cancer vaccines for the treatment of lymphoma.”

About Biovest International, Inc.

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in vaccinated patients suffering from indolent follicular non-Hodgkin’s lymphoma, confirming a previous positive Phase II study. BiovaxID has been granted “Fast-Track” status and Orphan Drug Designation for the treatment of follicular lymphoma by the FDA and Orphan Drug Designation by the European EMEA. A BiovaxID Phase II clinical trial treating patients suffering with mantle cell lymphoma, an incurable and aggressive type of non-Hodgkin’s lymphoma, also demonstrated promising results with the FDA granting Orphan Drug Designation for this second targeted indication.

Biovest is also developing and marketing a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™ which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: “ABPIQ”).

For further information, please visit: http://www.biovest.com

Forward-Looking Statements:

Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.

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FDA Approves Drug Treatment for Rare Cancer

The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

Cutaneous T-cell lymphoma is a slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash, and itching that can become severe. The skin may develop tumors that can become ulcerated, causing infection. In some cases, CTCL spreads to the blood, lymph nodes, or internal organs. There are about 1,500 new cases of CTCL every year in the United States.

Patients with localized CTCL on the skin are treated with topical agents or phototherapy, but chemotherapy may be used if the cancer advances.

Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used.

“This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. The FDA approved Istodax on Nov. 6, 2009.

Previous approvals for CTCL included Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene).

Istodax was evaluated based on two clinical studies involving a total of 167 patients. About 35 percent of patients in both of the trials experienced tumor responses, indicating a reduction of the size of tumors. Responses lasted a median of 15 months in one study and 11 months in the other study. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory, and X-ray examinations.

Common side effects include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells.

Istodax may cause changes in an electrocardiogram (ECG). Periodic blood tests should be done to monitor electrolytes, and periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Istodax may harm a fetus and women should not become pregnant while taking the drug.

Istodax is marketed by Gloucester Pharmaceuticals Inc. of Cambridge, Mass.

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Mayo Clinic Researchers find Adding Epratuzumab to Standard Therapy for Aggressive Lymphoma Produces Significant Overall Response

mdash - Adding a second monoclonal antibody drug to chemotherapy looks promising for treatment of diffuse large B-cell lymphoma, according to Mayo Clinic researchers working with the North Central Cancer Treatment Group (NCCTG) (http://ncctg.mayo.edu/). Results of this interim analysis were released May 15 as part of the 44th Annual Meeting of the American Society of Clinical Oncology.

Researchers found that 95 percent of patients responded to treatment that included the drug epratuzumab with the standard "R-CHOP" therapy. R-CHOP combines three chemotherapy drugs (cyclophosphamide, doxorubicin and vincristine) with the steroid drug prednisone and rituximab, a monoclonal antibody. Final results will be reported next year.

Diffuse large B-cell lymphoma is one of the most common and aggressive forms of non-Hodgkin lymphoma (NHL), a cancer of the white blood cells known as B-lymphocytes.

In 78 patients, researchers found:
• 95 percent of participants (75 patients) improved as a result of the treatment.
• 63 percent of participants (47 patients) were disease free.

Researchers also were able to look at the primary endpoint of the study — disease-free survival at 12 months — in 34 patients. Eighty five percent of that group, 29 patients, had no signs of lymphoma.

"These results are good, but whether it will turn out to be better than standard therapy is still unknown," says the study's lead author, Ivana Micallef, M.D. (http://mayoresearch.mayo.edu/mayo/research/staff/micallef_in.cfm), a Mayo Clinic hematologist.

Epratuzumab is much like rituximab because both are monoclonal antibodies, and both attach to proteins commonly found on the surface of B-cells — CD20 for rituximab and CD22 for epratuzumab. Both also are used to treat certain autoimmune disorders, such as rheumatoid arthritis and lupus. "In autoimmune disease, you are trying to stop the B-cells from making the antibodies that cause inflammation, but in cancer, these B-cells are malignant," says Dr. Micallef.

This is the first large study to combine epratuzumab with chemotherapy, in this case R-CHOP.
The rate of toxic side effects among enrolled patients was the same as seen in R-CHOP use, investigators say. "Overall, the combination was well tolerated," says Dr. Micallef. Patients may experience low blood counts, fatigue or infections.

As promising as these results look, researchers will not know if this new treatment provides superior results to R-CHOP unless the two regimens are compared with each other, she says.

Other NCCTG collaborators included Matthew Maurer, Paul Kurtin, M.D., and Thomas Witzig, M.D., all of Mayo Clinic; Daniel Nikcevich, M.D., St. Mary's Duluth Clinic, Duluth, Minn.; Michael Cannon and Dennis Moore, M.D., both of Cancer Center of Kansas PA, Wichita.

NCCTG is a national clinical research group sponsored by the National Cancer Institute. Its research and administration are based at Mayo Clinic. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States, Canada and Mexico. The group is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live.