TrovaGene Inc. (NASDAQ:TROV) PCM-075 Demonstrates Synergy
TrovaGene Inc. (NASDAQ:TROV) shares gained 9.9% after the biotechnology company reported positive preclinical research, demonstrating synergy of PCM-075 in combination with Johnson & Johnson (NYSE:JNJ) drug Zytiga. Trial results indicate that when combined, the two appear to signal a previously unknown pathway.
According To Trovagene Chief Scientific Officer, Mark Erlander, the unique combination could enhance the PCM-075 mechanism in arresting cells during mitosis with subsequent tumor cell death. The biotechnology company is investigating the adenosine triphosphate (ATP) competitive inhibitor for the treatment of metastatic castration-resistant prostate cancer.
“We previously completed a Phase 1 trial in metastatic solid tumor cancers, which provided a recommended Phase 2 dose and dosing schedule for PCM-075 in a combination regimen. We are working closely with key investigators to develop a Phase 2 clinical trial protocol with oral dosing of PCM-075 and abiraterone utilizing our existing solid tumor IND,” said CEO, Bill Welch.
Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) has already granted an Orphan Drug Designation to PCM-075 for the treatment of acute myeloid leukemia. According to TrovaGene Inc. (NASDAQ:TROV) CEO, the designation underscores the agency desire to accelerate the development of the therapy given that AML affects nearly 20,000 people every year in the U.S.
The Orphan Drug Designation will allow TrovaGene to accelerate the development of PCM-075. The designation also allows the company up to seven years of market exclusivity upon regulatory approval. The company plans to initiate a Phase 1b/2 open-label trial to evaluate the safety and anti-leukemic activity of the candidate drug in combination with standard care.
TROV Stock Performance
TrovaGene Inc. (NASDAQ:TROV) has been a shadow of itself in the market this year as the stock is down by more than 50% as it continues to trade in a strong downtrend. Investor confidence on the tock appears to have hit all-time lows, seen by the stock struggling to rise above the $1 a share mark.
The company reported a net loss of (-$36.81) million in its most recent quarter as it continues to waver on its path to profitability. Arousing further investors’ concerns is the rate at which the company is burning cash. TrovaGene Inc. (NASDAQ:TROV) reportedly has $7.78 million in the bank compared to negative cash flows of $29.40 million.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.