Monday, March 24, 2008

Bone and Cancer Foundation New Online Resource

New York City, New York, March 20, 2008 – The Bone and Cancer Foundation announced today the launch of a new online resource for the 400,000 patients whose cancers spread to their bones.

The Web site, www.boneandcancerfoundation.org, provides medically reviewed information for cancer patients unaware of treatment options and new discoveries which can improve a thier quality of life and possibly prolong survival.

The information is relevant for those who have or are treating breast cancer, prostate cancer, and osteonecrosis of the jaw. General information about bone metastasis and myeloma bone disease is also available.

Dr. David Roodman, Chairman of the Foundation’s Advisory Medical Panel stated, “Bone is one of the most frequent sites of metastasis and is responsible for severe pain, fractures with little or predisposing injury and a poor quality of life. Many patients and professionals are unaware of treatment options and new discoveries which can improve a patient’s quality of life and possibly prolong the survival. The Bone and Cancer Foundation’s major focus is to provide up to date information for patients and professionals to treat and ameliorate this devastating complication of cancer”. Dr. Roodman is Professor of Medicine and Vice Chair for Research, Department of Medicine, University of Pittsburgh School of Medicine and Director of the Myeloma Program at the University of Pittsburgh Cancer Institute.

About the Bone and Cancer Foundation and Paget Foundation

The Bone and Cancer Foundation is a program of The Paget Foundation for Paget’s disease of Bone and Related Disorders (www.paget.org), a national voluntary health agency founded in 1978. The Paget Foundation addresses several benign bone conditions and has also worked in the cancer and bone field for ten years, primarily in the area of medical education and research.

For additional information please contact the Bone and Cancer Foundation at 212-509-5188, toll free 888-862-0999 or send an email to bcfdn@aol.com

Monday, March 17, 2008

Oncolytics Biotech Inc. Presents Reovirus Research at AACR

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced preclinical work with reovirus are available today on the American Association for Cancer Research (AACR) website at www.aacr.org, and on the Oncolytics website at www.oncolyticsbiotech.com.

The first abstract, entitled "Targeting Multiple Myeloma with Oncolytic Viral Therapy" covers preclinical work using reovirus as a purging agent during autologous (harvested from the patient themselves) hematopoietic stem cell transplants for multiple myeloma. The results demonstrated that up to 70% of multiple myeloma cell lines tested showed reovirus sensitivity and reovirus induced cell death mediated through apoptosis. An oral presentation is scheduled to be delivered by Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre, Calgary, AB on Tuesday, April 15, 2008.

"This exciting work highlights the potential of expanding the use of the reovirus to include being used as a purging agent during autologous blood stem cell transplants, as well as a treatment for childhood sarcomas," said Dr, Matt Coffey, Chief Scientific Officer of Oncolytics.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of Phase I/II and Phase II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics, please visit www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the implication of the abstract and materials presented on the AACR website and at this meeting with respect to REOLYSIN(R), the Company's expectations related to the results of trials investigating delivery of REOLYSIN(R), and the Company's belief as to the potential of REOLYSIN(R) as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN(R), uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements.

%SEDAR: 00013081E

For further information: Oncolytics Biotech Inc., Cathy Ward, 210, 1167 Kensington Cr NW, Calgary, Alberta, T2N 1X7, Tel: (403) 670-7377, Fax: (403) 283-0858, cathy.ward@oncolytics.ca; The Equicom Group, Nick Hurst, 325, 300 5th Ave. SW, Calgary, Alberta, T2P 3C4, Tel: (403) 538-4845, Fax: (403) 237-6916, nhurst@equicomgroup.com; The Investor Relations Group, Erika Moran, 11 Stone St, 3rd Floor, New York, NY, 10004, Tel: (212) 825-3210, Fax: (212) 825-3229, emoran@investorrelationsgroup.com

Combination Therapy Effective Against Multiple Myeloma

Treatment with a combination of clarithromycin, lenalidomide and dexamethasone is successful in most patients with newly diagnosed symptomatic multiple myeloma, according to New York-based researchers.

"This paper," lead investigator Dr. Ruben Niesvizky told Reuters Health, "reports the efficacy and safety of a novel induction regimen, which has shown higher complete and overall response rates than other induction therapies."

In a phase II trial, Dr. Niesvizky of the New York Presbyterian Hospital-Cornell Medical Center and colleagues treated 72 patients in 28-day cycles. The patients were given dexamethasone 40 mg once weekly, clarithromycin 500 mg twice daily and lenalidomide 25 mg daily on days 1 to 21.

With response defined as a decrease in monoclonal protein of at least 50% in serum and 90% in urine, 65 of the patients (90.3%) had an objective response, the authors report in the February 1st issue of Blood. In total, 73.6% of the subjects achieved a decrease in monoclonal protein of 90% or greater.

The 52 patients who did not undergo hematopoietic stem cell transplant continued on therapy, and 37% of these patients had a complete response and 33% had a "very good" partial response. "The median event-free survival has not been reached," the researchers added, "and the actuarial 2-year event-free survival has reached 97.2%."

These results, Dr. Niesvizky said, are "comparable to high-dose chemotherapy programs." In the transplant patients, the investigators were able to "collect stem cells after lenalidomide therapy with successful engraftment after transplant."

Among other new findings, Dr. Niesvizky added, was "the safety and efficacy of dexamethasone in a once-weekly schedule" rather than the more toxic pulsing approach.

"Most adverse events were manageable," the researchers report. "The most common grade 3 or higher hematologic toxicities were neutropenia (19.4%), anemia (13.8%) and thrombocytopenia (22.2%). The most serious non-hematologic side effect was myopathy."

The results support further exploration of the approach for induction therapy, the researchers conclude, "because it produces high response rates and may increase disease-free and overall survival when used in conjunction with autologous transplantation."

SOURCE: Blood 2008;111:1101-1109.

Friday, March 14, 2008

Alternate day pomalidomide retains anti-myeloma effect with reduced adverse events and evidence of in vivo immunomodulation

Streetly MJ, Gyertson K, Daniel Y, Zeldis JB, Kazmi M, Schey SA.

Department of Haematology, Guys Hospital, Guys and St. Thomas' NHS Foundation Trust, London, UK.

We previously reported that daily dose pomalidomide (CC-4047), a thalidomide analogue, has excellent anti-myeloma activity but is associated with myelosuppression and deep vein thrombosis. We report here a phase 1 study to determine the maximum tolerated dose (MTD) of pomalidomide at 1 mg, 2 mg, 5 mg and 10 mg on alternate days (ad). Twenty patients with relapsed myeloma were treated. Grade 4 neutropenia occurred in all patients receiving 10 mg and the MTD was defined as 5 mg ad. No thrombotic events were observed. Pomalidomide was continued following the 4-week MTD study in 17/20 patients for a median of 14 months. 10% of patients had a complete response and >50% reduction in paraprotein was achieved in 50% of subjects. Progression-free survival was 10.5 months and median overall survival was 33 months. A significant rise was observed in the proportion of CD8(+) cells. Alternate day pomalidomide was associated with a marked reduction in the incidence of thrombosis whilst maintaining excellent anti-myeloma activity. This trial provides further in vivo evidence that pomalidomide modulates the immune system in myeloma patients. Phase 2 studies to further assess the optimal schedule of administration and anti-myeloma activity of this agent are planned.

PMID: 18324965 [PubMed - in process]

Anti-CD20 monoclonal antibody therapy in multiple myeloma

Kapoor P, Greipp PT, Morice WG, Rajkumar SV, Witzig TE, Greipp PR.

Division of Hematology, Mayo Clinic, Rochester, MN, USA.

CD20 is a particularly appealing target that is expressed on the surface of almost all B cells, with no significant shedding, secretion or internalization. In contrast to the demonstrated efficacy of anti-CD20 strategies in various B-cell lymphoproliferative disorders, the role of such therapy in multiple myeloma is undetermined and controversial. The expression of CD20 by myeloma cells is heterogeneous, and can be detected only in 13-22% of patients. However, there is increasing interest in testing anti-CD20 therapy in myeloma because of recent studies suggesting the existence of clonogenic CD20-positive precursor B cells in the disease. This article reviews the rationale, preclinical and clinical activity of anti-CD20 therapy in myeloma. Clinical trials show that anti-CD20 therapy with rituximab elicits a partial response in approximately 10% of CD20(+) patients with multiple myeloma. In addition, there is preliminary evidence of disease stabilization in 50-57% of CD20(+) patients for a period of 10-27 months. Further large-scale clinical trials are therefore needed to establish the role of this promising strategy in the treatment of myeloma.

PMID: 18318769 [PubMed - as supplied by publisher]

Tuesday, March 11, 2008

Drug Research: ACE-011 Bone Forming Agent

Acceleron Pharma, Inc., a biopharmaceutical company developing therapeutics that modulate the growth of tissues including bone and muscle, was recently selected to receive a Biotech Investment Award from the Multiple Myeloma Research Foundation to support the research and development of ACE-011, a bone forming agent, for the treatment of multiple myeloma.

In addition, Acceleron announced that it began an additional study of ACE-011.

“With this grant, we will continue to aggressively pursue the development of ACE-011, which has shown encouraging preclinical and clinical effects on bone formation, to treat the complications of bone loss associated with multiple myeloma,” said John Knopf, chief executive officer of Acceleron.

The multiple dose study will be conducted in healthy, post-menopausal women. Subjects will receive four monthly subcutaneous doses of either ACE-011 or placebo. The primary objective of the study is to assess the safety, tolerability and pharmacokinetics of ACE-011. The pharmacodynamic effects of ACE-011 on bone will also be measured.

In numerous preclinical models of bone loss, ACE-011 increased bone mineral density, improved bone architecture, increased the mineral apposition and bone formation rates and improved bone mechanical strength. These effects have been demonstrated in therapeutic models of bone loss in which ACE-011 stimulated bone formation — a significant unmet medical need that is underserved by current treatments for bone loss, according to Acceleron.

New Biological Agents Added to Treatment Algorithm for Multiple Myeloma

Novel therapy using several targeted agents has been incorporated into new guidelines from the National Comprehensive Cancer Network (NCCN) for treatment of multiple myeloma, presented at the NCCN 13th Annual Conference: Clinical Practice Guidelines and Quality Cancer Care.

The new agents that have been added to the NCCN's guidelines for treating cancer patients include:
· The proteasome inhibitor bortezomib. Proteasomes are enzymes that play a role in regulating cell function and growth.
· Thalidomide, which appears to inhibit the growth and survival of myeloma cells and to inhibit the growth of new blood vessels. Its precise mechanism of action is unknown. In the 1960s thalidomide was found to be responsible for birth defects and must not be taken by women who may become pregnant.
· Lenalidomide, an analog of thalidomide, which acts as an immune modulator, reducing cytokine proliferation that occurs in multiple myeloma.
· The anthracycline doxorubicin hydrochloride liposome injection, a cytotoxic agent.

"The effect on overall survival with these drugs is as yet unknown," said Kenneth C. Anderson, MD, the Kraft Family Professor of Medicine,
Harvard Medical School, Boston, Massachusetts. "New drug combinations for front-line therapy are under evaluation using bortezomib, thalidomide, and lenalidomide."

In the updated guidelines for treatment of multiple myeloma, the drugs are indicated for use in advanced multiple myeloma patients along with cyclophosphomide and the combination of etoposide, dexamethasone, cytarabine, and cisplatin, Dr. Anderson said in a presentation on March 7th.

The guidelines suggest that other therapies for the treatment of relapse include thalidomide, lenalidomide, and bortezomib either as single agents or in combination with dexamethasone. Dr. Anderson also said that bortezomib can be used in combination, including with doxorubicin hydrochloride liposome injection.

"Other novel therapies to be conducted in clinical trials should also be considered," he added. The use of the drugs in the salvage setting is only for patients who have opted against transplantation to try to cure the disease. Thalidomide, bortezomib, and lenalidomide are mentioned in the guidelines for maintenance in transplantation.

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