Biothera Releases Colorectal Cancer Study Results at ASCO
Overall Response Rate Nearly Doubles
Median Progression-Free Survival Increases 38% to 22 weeks
ORLANDO, FLA — May 29, 2009 — The combination of Imprime PGG®, Erbitux® (cetuximab) and Camptosar® (irinotecan) nearly doubled the overall response rate of second- and third-line metastatic colorectal cancer patients compared with the standard of care of cetuximab and irinotecan alone, according to data released today at the American Society of Clinical Oncology (ASCO) annual meeting.
Median progression-free survival increased 38% to 22 weeks with the Imprime PGG combination, compared with 16 weeks for the standard of care. The overall response rate (complete response + partial response) was 30% with the Imprime PGG combination, compared to 16% for the standard of care. The disease control rate (complete response + partial response + stable disease) was 100% for the Imprime PGG group, compared with 61% for the standard of care.
“We believe Imprime PGG has the potential to significantly benefit cancer patients,” said Daniel K. Conners, Biothera chairman and Pharmaceutical Group president. “We are working diligently to develop this drug and bring it to market as quickly as possible.”
Imprime PGG is a targeted immunotherapeutic drug from Biothera that works synergistically with monoclonal antibodies through specific innate immune cell activation. Imprime PGG is a Phase II investigational drug in development for the treatment of a wide range of cancers, including colorectal and lung cancer.
“Imprime PGG has a mechanism of action, which involves the recruitment of innate immune cells not normally engaged in the fight against cancer, that is uniquely different from any other cancer drug on the market today,” said Conners.
Study Design
The Phase Ib/II, sequential, dual-arm, open-label, dose-escalation study is evaluating the safety and efficacy of Imprime PGG plus irinotecan and cetuximab (Arm #1) or Imprime PGG plus cetuximab alone (Arm #2) for second- and third-line colorectal cancer patients. Results from study Arm #1 are the subject of the data released at ASCO.
The first arm of the study included 10 patients dosed with 2 mg/kg, 4 mg/kg or 6 mg/kg of Imprime PGG in combination with standard doses of irinotecan and cetuximab. Imprime PGG was safe and well tolerated.
All tumor responses and duration of responses were based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. The benchmark data for combination treatment of irinotecan and cetuximab in second- and third-line colorectal cancer patients is based on the EPIC Study (Sobrero et al., JCO, 2008), which was conducted in a similar patient population.
Study Results
Chemotherapy Alone* |
Chemotherapy + Erbitux* |
Chemotherapy + Erbitux + Imprime PGG** |
|
| Response Rate | 4% |
16% |
30% |
| Stable Disease Rate | 42% |
45% |
70% |
| Disease Control Rate | 46% |
61% |
100% |
| Progression-Free Survival | 10 weeks |
16 weeks |
22 weeks |
| # Patients in trial | 650 |
648 |
10 |
*EPIC Study (Sobrero et al., JCO, 2008)
** Biothera Study
The second arm of the Biothera colorectal cancer study is ongoing. This arm, which is fully enrolled with 22 patients, is studying whether the combination of Imprime PGG and cetuximab can safely achieve positive outcomes without the use of chemotherapy.
"The initial results of the second arm of the trial are highly promising,” said Conners. “Improving or maintaining efficacy while eliminating the harmful side effects of chemotherapy would be a significant benefit to cancer patients and it would potentially lower treatment costs.”
About Imprime PGG®
Imprime PGG is a novel immunotherapy that works synergistically with anti-tumor monoclonal antibodies to activate a large population of the body’s immune cells (neutrophils) to kill cancer cells. Unlike other drugs that trigger a broad innate immune response, Imprime PGG selectively activates immune cells without inducing systemic pro-inflammatory cytokines, which reduces potential side effects. As a platform therapeutic in oncology, Imprime PGG has the potential to improve patient response rates for existing monoclonal antibody therapies in approved indications, create new indications for these drugs and enhance the efficacy of development-stage monoclonal antibody drugs.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer. (www.biothera.com)
Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com