Amgen’s Trouble in Lung Cancer Trials (AMGN)
Amgen (NASDAQ: AMGN) and Takeda Pharmaceutical Company Limited’s Millennium Pharma have issued some disappointing news on the lung cancer front. The companies have announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin as a first-line treatment of advanced non-small cell lung cancer has been temporarily suspended.
This follows a planned safety data review of 600 patients by the study’s independent Data Monitoring Committee. Motesanib is part of a broad co-development program between Amgen and Takeda.
The monitoring committe recommended that enrollment in the study be suspended. This is based on an observation of higher early mortality rates in the motesanib group compared to the placebo group.
The committee recommended that the squamous patients with immediately discontinue motesanib therapy based on an observation of a higher incidence of hemoptysis, but it did not recommend for the non-squamous patients to discontinue motesanib therapy.
Here are the full details from Amgen.
Jon C. Ogg
November 19, 2008
Oncolytics Biotech: New Emerging Cancer Play? (ONCY)
Oncolytics Biotech Inc. (NASDAQ: ONCY) is a small biotech based in Canada which many traders have not heard of. The company has announced interim results of a Phase II study of intravenous REOLYSIN® in patients with sarcomas metastatic to the lung (lung cancer).
The company presented data at ASCO over the weekend entitled “A Phase II Study of Intravenous REOLYSIN in the Treatment of Patients with Bone and Soft Tissue Sarcomas Metastatic to the Lung.”
The results demonstrate on an interim basis that the treatment has been well tolerated to date, with 8 of 16 evaluable patients experiencing stable disease for periods ranging from two to more than ten 28-day cycles.
The company had previously announced that the third patient treated in the study was demonstrated to have stable disease by RECIST criteria for more than six months as measured by CT scan. A PET scan taken at the same time showed that any residual mass was metabolically inert. While this is based upon a small target group, this is also a tiny company that could see major rewards and major returns if this can show impressive numbers in larger test groups.
Shares are up about 7% at $2.31 today after almost 1-hour of trading. Its 52-week adjusted trading range is $1.44 to $2.77. Its normal trading volume is 41.850 shares and it has already more than doubled its normal trading volume. This one is probably too thin for CNBC to pick up today and with under a $100 million market cap it might avoid it entirely.
The company does have a small balance sheet but also has ample liquidity to fund itself for roughly three years or more at current cash burn rates.
Jon Ogg
June 2, 2008