Inovio Pharmaceuticals (INO) refuted claims Wednesday that management readied to release poor clinical trial results for its drug treating human papillomavirus (HPV), a common sexually transmitted disease that can cause cervical cells to become abnormal and lead to cervical cancer.
In a press release this morning, Inovio said that it is “hopeful” that its treatment will prove to be a viable alternative to more invasive therapies for infected women. It plans to release results of its phase II human trials by the end of July.
“There exists the prospect that our immunotherapy approach may eliminate the presence of the HPV virus to minimize future recurrences,” the company said in a statement.
TheStreet.com senior columnist Adam Feuerstein wrote an article, published yesterday, asserting that Inovio’s CEO Joseph Kim laid the foundation “for a massive spin job” to “cushion” the failure of Inovio’s HPV vaccine in clinical trials. He analyzed comments made by Kim in a Seeking Alpha article suggesting that the primary risk to Inovio is that investors take disappointing results from its Phase II study and see the company as a sell, instead of accounting for data related to T-cells, some types of which destroy other cells infected with viruses. Feuerstein also wrote that the company’s track record for DNA-vaccines is “abysmal.”
In his article, Feuerstein maintained that the T-cell data is not included as a goal in the study and that, if the Phase II data does not show the HPV treatment shrinks cervical lesions more than a placebo, the company’s drug should rightly be considered a failure and its stock should fall. Inovio shares fell 13% as the article circulated.
Many on StockTwits said the fall was overdone. They argued that shares would rise ahead of the July data release. Sentiment on the stock is 93% bullish, according to StockTwits’ analytics.
Some investors pointed to Inovio’s HPV treatment results in animals as evidence that it would be successful in human beings.
In the press release, Inovio management again asserted that the T-cell response data is important. “T cells are the vital agent of oncology immunotherapies…Overall, Inovio designed a technology platform to generate antigen-specific T cells with the potential to eliminate cancers and infectious diseases… No other technologies have demonstrated T cell responses on par with Inovio’s, including those referenced in yesterday’s article.”
The economic opportunity for a successful HPV treatment is large. About 79 million Americans have HPV and another 14 million become infected every year, according to the Center for Disease Control. Though the infection can clear up on its own, many women who have persistent irregular cervical cells from the disease must have cervical cells removed via freezing or the use of an electrified wire loop. The procedures are uncomfortable and can be painful.
If left untreated or undiagnosed, abnormal, HPV-infected cervical cells can grow into cancerous lesions. About 70% of cervical cancers are caused by two types of HPV, according to the World Health Organization.