Chinese biotech company Pioneer Pharmaceuticals has seen its stock price continue to rise as it recently touts a drug that is purported to treat Chinese Communist pneumonia (COVID-19). However, Reuters recently reported that the drug was developed and tested without transparency, and that medical experts considered the company’s claims of “efficacy” to be highly questionable.
Reuters reported on Friday (May 14) that when the media outlet asked Zeid Kayali, the lead clinical trial investigator at Pioneer Pharmaceuticals, about the clinical trial of Proxalutamide, Kayali said he was not in charge of the clinical trial, but that as of early May, Pioneer Pharmaceuticals had not given any patients the drug at all.
In response, Pioneer’s chief financial officer Lu Yan explained in an interview that Kayali was only one of the company’s clinical trial investigators and did not necessarily have full knowledge of the situation, and that he would not comment further on the company’s announcement about Proxalutamide last month.
Generally speaking, most pharmaceutical companies provide some basic information about their clinical trials to outsiders, including who is leading the trial and which research organization or medical institution is responsible for ensuring the safety and scientific validity of the subjects, the paper noted. However, Lu Yan refused to disclose information about the other principal investigators or researchers in charge of the clinical trial site at Pioneer Pharmaceuticals, citing the protection of company secrets, indicating that the company’s experiments were completely opaque.
Stephen Ostroff, a former FDA chief scientist, was quoted as saying that the lack of transparency in Pioneer’s trials and the contradictory claims made by the company’s researchers to previous claims made by the company made the company’s claims of efficacy highly suspect.
In fact, Pioneer Pharmaceuticals claimed in March that results from a clinical trial conducted by the company in Brazil showed that Proxalutamide reduced the risk of death in 92% of patients with CPC pneumonia; and on April 25, it also claimed that the first patient had been recruited and enrolled in a Phase 3 clinical trial of the company’s drug Proxalutamide for the treatment of CPC pneumonia in the United States. dosing. The publicity has caused the company’s share price to soar since March, causing the Hong Kong-listed company’s share price to almost triple and its market capitalization to soar from HK$6.6 billion to the current HK$23.4 billion.
However, as of now, Proxalutamide has still not received any national regulatory approval, and its claimed clinical trial results in Brazil have not been tested by its peers.
According to public information, Proxalutamide, which is translated as “Proclutamide” in Chinese, is a new generation of androgen receptor (AR) antagonist developed by Pioneer Pharmaceuticals, which was originally used mainly for the treatment of tumor and non-tumor AR-related diseases. After the outbreak of the Chinese communist pneumonia epidemic, the company’s researchers claimed that the drug not only blocked AR signaling, but also reduced the expression of two key proteins that allow the virus that causes COVID-19 disease to enter the host cell, and thus Proxalutamide began to explore its potential as a treatment for Chinese communist pneumonia.
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