BOTHELL, Wash.  and VANCOUVER, British Columbia, April 30, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced initiation of the Borealis-2™ clinical trial, an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy treatment.

Borealis-2 will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary endpoint of the trial is overall survival, with secondary objectives to evaluate safety, tolerability, tumor response rates and the effect of therapy on heat shock protein (Hsp27) levels and circulating tumor cells.

"Resistance to initial chemotherapy is a frequent occurrence in patients with advanced bladder cancer, and is often frustrating for physicians and devastating for patients who have limited treatment options available," stated Noah M. Hahn MD, Associate Professor of Medicine at Indiana University Simon Cancer Center and one of the primary investigators on the trial. "We hope that this trial will shed new light on the role of Hsp27 in bladder cancer and the ability of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome resistance and prolong survival."

Borealis-2 is the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer.  Borealis-1™ is a company-sponsored, randomized, placebo-controlled Phase 2 trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 trial of OGX-427 in bladder cancer as part of the ORCA™ program.

Borealis-2 is being conducted at approximately 30 sites in the U.S. and is sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer Institute and Dr.Jonathan Rosenberg from Memorial Sloan-Kettering Cancer Center will serve as the primary investigators on the trial. Please visit http://clinicaltrials.gov/show/NCT01780545 for more information.

ABOUT BLADDER CANCER 
Nearly 400,000 cases of bladder cancer are diagnosed per year, worldwide. Approximately 30 percent of patients have locally invasive or metastatic disease at the time of diagnosis, and 50 percent of patients with locally invasive disease relapse with metastases within two years. Limited options exist for both the first- and second-line treatment of advanced bladder cancer. First-line platinum-based chemotherapy regimens result in a median overall survival of approximately 12-15 months. Docetaxel is commonly used in second-line treatment, with a reported median overall survival of approximately six months. Given acquired treatment resistance and these short survival times, there continues to be a high unmet need for additional therapeutic options for this patient population.

ABOUT OGX-427 and ORCA™
OGX-427 is a once-weekly intravenous (IV) drug that is designed to inhibit production of heat shock protein (Hsp27) to disable cancer cells' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.

The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of OGX-427. Phase 2 clinical trials are underway in bladder, lung and prostate cancers, with additional trials expected to initiate this year. For more information on OGX-427 and ORCA, please visit www.OncoGenex.com.

ABOUT ONCOGENEX
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE:  TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com.

Oxford BioTherapeutics (OBT) and Boehringer Ingelheim recently announced the companies’ new alliance focused on the discovery of novel cancer antibody targets.

The companies will identify these targets with assistance from OBT’s OGAP discovery platform. The OGAP proteomic database represents the world’s largest proprietary collections of disease-associated proteins. OGAP contains proteomic data on more than 7,500 cancer membrane proteins and proprietary protein disease expression information more than three-quarters of the entire human proteome. OGAP has sequenced over two million human protein fragments in 50 different human tissues that represent 60 diseases, including 25 forms of cancer.

Under the collaboration, OBT will validate certain targets it has discovered that are compatible with targeting by various antibody drug formats across several cancer indications. After completing these activities, Boehringer Ingelheim will have the exclusive right to develop and commercialize antibody products for selected programs.

An undisclosed upfront payment and FTE funding will be given to OBT for its activities under the collaboration. Additionally, OBT will be eligible for certain milestone payments once the company achieves specified discovery, development, and commercialization milestones, as well as royalties on sales of any resulting products.

“Selecting the right target is fundamental for the successful development of a first in class antibody product drug and we are delighted to collaborate with a company of the caliber of BI in this excited area of cancer antibody development,” Christian Rohlff, CEO of OBT said in a statement.

Source: Oxford BioTherapeutics

Last Updated: 4/30/13; 9:50AM EST

According to a new report published by the Pharmaceutical Research and Manufacturers of America (PhRMA), there are currently more than 240 drugs in development for treatment of multiple blood cancers.

The 241 drugs in development are in human clinical trials or under review by the US Food and Drug Administration (FDA) for treatment of leukemia, lymphoma, myeloma, and more. An estimated 149,990 Americans will be diagnosed with leukemia, lymphoma, or myeloma in the United States in 2013, according to the American Cancer Society. Additionally, an estimated 54,000 people will die. According to the report, every four minutes a person is diagnosed with leukemia, lymphoma, or myeloma, which accounts for nine percent of all cancers diagnosed each year.

There are currently 98 medicines in development for lymphoma, including Hodgkin and non-Hodgkin lymphoma, which affects roughly 80,000 Americans per year; 97 medicines for leukemia, including the four major types that affect nearly 50,000 people in the US per year; 52 medicines for myeloma, which affects more than 22,000 people in the US per year; 24 medicines targeted at hematological malignancies, which affects bone marrow, blood and lymph nodes; 15 for myeloproliferative neoplasms like myelofibrosis, polycythemia, vera, and essential thrombocythemia; and 15 for myelodysplastic syndromes which affects blood and bone marrow.

According to a study from Boston Healthcare, several trends are expected to increase the pace and complexity of new cancer medicines including scientific advances improving the understanding of cancer, cancer treatments moving towards targeted therapies, and combination treatments which are showing promising results. There has been a significant progress in fighting cancer in the recent years, with falling death rates and an increase in survival rates. Since 1975, medicines account for 50-60 percent of survival rate increases, according to a study.

These new medicines in development offer great hope for improving survival for patients affected by these cancers of the blood.

Additionally, PhRMA has raised more than $100,000 to establish a new grant for blood cancer research.

Source: PhRMA

Last Updated: 4/26/13; 2:55PM EST

According to a new study from California, young women diagnosed with breast cancer who delayed surgery significantly decrease their survival rates.

This was particularly true among African American or Hispanic, poor, or inadequately insured young women. The study found that among these younger women, a treatment delay longer than six weeks was significantly associated with worse five-year survival compared to those who were treated within two weeks or within two to four weeks.

Researchers from UC Irvine and Children’s Hospital of Orange County focused on patients with breast cancer between the ages of fifteen and thirty. Women who are diagnosed with breast cancer in this age group account for only five to six percent of all breast cancer patients; however patients in this age group typically have more aggressive cancer. Therefore, initiating treatment early is of high importance.

The researchers used data from the California Cancer Registry database, identifying 8,860 women who were diagnosed between 1997 and 2006. The records showed women who initiated treatment within two weeks of diagnoses and those who waited at least six weeks. They found that women who delayed treatment for at least six weeks were not alive five years after diagnosed compared to 16 percent of women who initiate treatment within two weeks and 17 percent of women who initiate treatment within two to four weeks.

They found 18 percent of women with low socioeconomic status (SES) delayed treatment for at least six weeks versus 8 percent of women with high SES, and 28 percent of the low SES women died within five years compared to 11 percent of women with high SES. For women with no health insurance or were insured through a public program, 18 percent waited at least six weeks to initiate treatment and 31 percent died within five years. For women with private health insurance, 10 percent delayed their treatment for at least six weeks and 14 percent died within the five years.

When looking at the race, ethnicity, insurance status and SES of the women together, they found that five-year survival rate was 57 percent for African Americans, 74 percent for Latinas, 81 percent for Asian Americans, and 86 percent for whites.

The study was published online by the journal of JAMA Surgery.

Source: JAMA Surgery

Last Updated: 4/25/13; 2:15PM EST