OBI Pharma Inc (台灣浩鼎) yesterday downplayed concerns about data on the clinical trials of its new breast cancer drug, OBI-822, as its shares fell by the maximum daily limit for the second consecutive session this week to NT$481.5.
The company, which has been embroiled in an insider trading scandal over the past few months, held a news conference in Taipei following a presentation on the second and third-phase clinical trials of OBI-822 at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
OBI Pharma said that a significant improvement in progression-free survival (PFS) was seen in about 50 percent of the patients who demonstrated an immune system response to the vaccine, compared with those who received a placebo.
PFS among the subset of patients who developed an immune system response improved to 49 weeks compared with 40 weeks in the placebo group, suggesting a positive effect, the company said.
However, analysts held a reserved outlook on the outcome of the clinical trial after the company briefed local investors on its ASCO presentation in Taipei on Sunday, while declining to comment on regulatory approval progress and commercialization.
For patients who did not develop an immune response, PFS decreased to 24 weeks compared with 40 weeks for patients taking placebo, indicating a potential negative effect on some patients, Yuanta Securities Investment Consulting Co (元大投顧) analyst Peggy Lee (李珮菁) said in a note published on Monday.
She added that the eight-week gain in PFS among patients who have developed a response was not outstanding.
“In our view, the negative effect on patients who did not develop an immune response was unexpectedly negative,” she said.
OBI Pharma rejected the reports as misinformed in a filing with the Taiwan Stock Exchange on Monday evening.
The company said that all patients who received the full regimen of nine injections saw PFS improvements of varying degrees depending on the level of immune system response triggered by the drug.
“The claims of negative effects are baseless, with patients reporting no adverse reactions apart from redness and slight inflammation at the injection site,” the company said in the filing.
The company was also especially strident in correcting analysts’ view that there was no significant difference in globo H expression between patients categorized as responders, non-responders and the control group.
“Our data show the exact opposite,” the company said.
OBI-822 is designed to target globo H and trigger the immune system to respond with cancer-destroying T cells, the company said.
“Although the study shows that there is no significant link between globo H, OBI-822 is effective in encouraging the immune system to produce the desired cancer-fighting antibodies even among patients with with low globo H presence. Therefore, the drug is effective,” the company said, adding that the degree of improvement is more pronounced among patients with higher antibody production.
The company also said that analysts had taken the PFS results out of context, as they had compared OBI-822 with seemingly superior clinical trial results of Ibrance, a rival treatment that has severe side effects, including heightened risk of infections and lowered white blood cell count.
Separately, the company yesterday announced that sales last month came to NT$92.38 million (US$2.86 million), its first entry this year. The money is from a licensing transfer fee for Dificid, a clostridium difficile-associated diarrhea drug the company developed that was approved by the US FDA in 2011.
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