Threshold Pharmaceuticals (NASDAQ:THLD)
On Monday December 7, 2015 shares of Threshold Pharmaceuticals fell 82% after the company announced the failure of two phase 3 clinical trials. The two phase 3 clinical trials were MAESTRO and TH-CR-406/SARC021. Each phase 3 trial was treating a different indication, but used the company’s drug Evofosfamide together with some type of chemotherapy treatment. Both treatments failed to produce statistically significant results, thus the reason for the huge fall in share price.
The phase 3 MAESTRO study treated patients with advanced metastatic pancreatic cancer, but one thing to note is that these are patients who had not been previously treated with any other therapy. Some patients were given the company’s drug Evofosfamide in combination with gemcitabine — chemotherapy drug — and other patients were given gemcitabine alone. The trial results concluded that the drug in combination with gemcitabine failed to improve Overall Survival — OS — in patients with advanced pancreatic cancer, against gemcitabine alone.
The second phase 3 trial treated patients with soft tissue sarcoma — cancer that begins in tissue of the body and spreads — and each patient was classified into two different dosing groups once again. One group of patients took the company’s drug Evofosfamide in combination with Doxorubicin — chemotherapy drug — and the other group of patients took Doxorubicin alone. Once again the combo treatment by Threshold failed to improve Overall Survival compared to Doxorubicin alone.
These two phase 3 trial failures is a huge blow for the company, and now it has decided to terminate development of this drug in their pipeline. The news gets worse because it means that Merck KGaA might soon terminate its partnership on the Evofosfamide compound. It has not happened yet, but since Threshold is putting a stop to this program it is highly likely that’s what will happen next. It is why I believe it is best to avoid investing in Threshold until that piece of news hits the wire first, because it’s share price could tank further.
Bluebird Bio (NASDAQ:BLUE)
On Tuesday December 8, 2015 shares of Bluebird Bio tanked 37% after the company reported less than stellar results of its gene therapy product at the ASH meeting. ASH stands for American Society of Hematology, and that is where the company presented updated results for its gene therapy product targeting patients with Sickle Cell disease. The data that left investors in mixed-state came from three patients treated with the company’s Lentiglobin gene therapy.
The U.S. study with the three patients is known as the HB-206 study and it has not been able to achieve the desired results from the other study. The reason for the run-up in share price this past year was that many believed that the treatment with Lentiglobin could cure patients from having to go for blood transfusions. A patient from a French study was able to go transfusion free for one year after treatment with Lentiglobin. The problem is that these other three patients in the U.S. study have not seen similar results.
Analysts and investors now see that Lentiglobin might only work for a subset of patients with Sickle-Cell disease, and not the entire population. This caused analysts to lower revenue expectations, as the targeted gene therapy might not make as much money as it would if it had produced a complete cure for all patients. On that note, I believe that the share price may eventually recover with some positive developments, but it will be a huge uphill battle considering the recent news has not been what investors were expecting.
Synthetic Biologics (NASDAQ:SYN)
On Wednesday December 9, 2015 Synthetic Biologics announced positive phase 2 results for patients with Irritable Bowel Syndrome — IBS. These patients had IBS with constipation and the company’s phase 2 trial used its drug, known as SYN-010, to treat these patients. The main goal of the trial was to see if the company’s drug could reduce the amount of breath methane in these IBS patients.
The way to observe this was to see if SYN-010 could reduce breath methane at either day 7 or day 28, after patients had received treatment. Only the high dose of 42 mg lowered breath methane at day 7, while both the 42 mg and 21 mg reduced breath methane at day 28. Synthetic Biologics stock has been struggling lately despite some recent good news about clinical trial programs. This could be partly attributed to the fact that the stock saw pressure when it tanked after failing to produce statistically significant results in the Multiple Sclerosis trial.
The good part about the lower dose of 21 mg is that it also increased stool frequency for these patients who had been having severe constipation. Even better, the 41 mg dosage level was able to reduce abdominal pain in this patient population. This initial phase 2 proof of concept study only tracked patients over a 4-week period, an extension to this study has been added to treat patients over an 8-week period. The results seem to be quite good, and Synthetic Biologics is already in the process of planning out a larger phase 3 trial which should begin patient enrollment sometime in 2016.
[Image Courtesy of Wikipedia]
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