OBI Pharma shares yesterday rallied after the American Society of Clinical Oncology (ASCO) published a company-sponsored abstract saying that the firm’s breast cancer vaccine was effective among patients that produced a humoral antibody response in a clinical trial.
Shares rose 3.16 percent to NT$490 on the Taipei Exchange, outperforming the over-the-counter market’s 0.54 percent rise, and was nearly 30 percent higher than its closing at NT$378.5 at the beginning of this month.
OBI Pharma on Thursday said in an abstract that it had seen positive results in subjects with immunoglobulin G (IgG) antibody immune reactions regarding its phase two and three clinical trials on OBI-822.
OBI-822 is designed to trigger the body’s immune system to generate antibodies that help activate cytotoxic T cells to destroy cancer cells.
The abstract concluded that although OBI-822 did not improve the progression-free survival (PFS) in the intention-to-treat (ITT) control group, patients who developed an immune response to the vaccine saw significant improvement in PFS, as well as interim overall survival.
The clinical trial was conducted on 349 patients, of whom 348 were placed in the ITT control group to receive the drug or placebo, and 168 patients, or 48 percent of participants, were given a full regimen of nine injections, according to the abstract.
Half of the trial patients generated an immune system response, and among them the P-value of PFS printed 0.029, while the P-value of overall survival was 0.04, the company said, adding that the outcome was favorable compared with the control group that did not receive the treatment.
The abstract also said that OBI-822 was well-tolerated by patients who did not report major adverse reactions to the vaccine.
Detailed results of the study are to be presented on June 4 during the ASCO’s annual meeting.
OBI Pharma has been embroiled in controversy since Feb. 21, when the company announced that the results of its second and third-phase clinical trials of OBI-822 showed no statistical significance. It also faced allegations of market manipulation and insider trading involving chairman Michael Chang (張念慈) and former Academia Sinica president Wong Chi-huey (翁啟惠).
Chang maintained that the outcome of the clinical trials was due to flaws in the methodology.
For now, the company is likely to redesign its methodology to better reflect the efficacy of the drug, industry observers said, adding that it is unlikely that the drug will complete the required clinical trials and see commercialization within five to eight year’s time.
“Following the results, we believe the company will recruit patients who have shown a Globo-H IgG response after receiving the drug for a period of time in the treatment group in its US/global phase III trials,” Yuanta Securities Investment Consulting Co (元大投顧) analyst Peggy Lee (李珮菁) said in a client note.
Lee said this move would noticeably increase the difference between the treatment group and the control group, thereby increasing the trial success rate, but it will lower the applicable patient population.
“In addition, we believe the positive results will increase the chance of OBI cooperating with global pharmaceutical companies,” Lee said.
OBI Pharma yesterday was fined NT$1 million (US$30,532) by the Taipei Exchange for poor information disclosure.
The company was found to have failed to publish information about shareholding changes by its major stakeholders, including Alpha Corporate Holdings Ltd, in the 2013 and 2014 annual reports, the Taipei Exchange said on its Web site.
OBI Pharma last month confirmed that senior finance manager Chang Sui-fen (張穗芬) failed to register stock trading activities by the British Virgin Islands-registered Alpha. At the time, the company pledged to begin an internal investigation and take appropriate action in a bid to limit the fallout.
Additional reporting by Kevin Chen
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