LiPlaCis Shows Promise in Phase 2 Part of Trial Dealing with Hard to Treat Breast Cancer

LiPlaCis Shows Promise in Phase 2 Part of Trial Dealing with Hard to Treat Breast Cancer

Three of five patients with breast cancer that had spread to other organs responded to Oncology Ventures’ LiPlaCis or had their disease become stable with it, according to early results of the Phase 2 portion of a Phase 1/2 clinical trial.

Oncology Ventures, a spinoff of Denmark’s Medical Prognosis Institute, is continuing to enroll patients in the trial (NCT01861496). It hopes to recruit 12 to 15 women with advanced breast cancer whose tumors are likely to respond to LiPlaCis, a platinum-based chemotherapy with a unique formulation. That formulation is a capsule that delivers the therapy directly to a tumor.

The Medical Prognosis Institute developed a tool that does a good job of predicting which advanced breast cancer patients are likely to benefit from LiPlaCis.

Eight patients have been enrolled in the trial so far, with five receiving the therapy.

One patient had a partial response of more than a 30 percent reduction in her tumor at 32 weeks. Surgery and a compound designed to increase the effectiveness of other treatments had failed to reduce the size of her tumor, although it became stable — that is, neither growing nor shrinking.

Another patient’s cancer stabilized after receiving LiPlaCis for more than 24 weeks. She had received several treatment regimens before LiPlaCis, with the best response being a stable disease.

She also had to have surgery to remove fluid from her lungs after the cancer spread. Since she started LiPlaCis, she has needed no more rounds of the surgery, and has resumed part-time work.

LiPlaCis has stabilized for 17 weeks the cancer of a patient whose disease had spread to her liver. At the start of the study, several biomarkers showed significant damage to her liver. LiPlaCis has returned these readings to normal levels.

The fourth patient treated with LiPlaCis achieved a stable disease for a short time, while the fifth patient’s cancer progressed.

Researchers noted that both had received 12 previous treatments, including another platinum-based chemotherapy — Paraplatin (carboplatin). This suggested that their tumors have become platinum-therapy-resistant.

Cisplatin is one of the most active cancer therapies available. But its current formulation, marketed as Platinol, damages healthy as well as cancerous cells.

Oncology Ventures has encapsulated cisplatin in soluble spheres that it calls LiPlasomes to deliver the therapy specifically to tumor tissue.

The trial results so far show that patients tolerate LiPlaCis well. It has triggered few side effects, and most have been moderate, researchers said.

“I’m excited about these early clinical results of LiPlaCis in hard to treat metastatic breast cancer and look forward to finalizing the study,” Dr. Erik Hugger, a trial investigator at Vejle Hospital in Denmark, said in a news release. Vejle is one of the trial facilities.

“I’m excited about these promising early results of the Phase 2 part of the LiPlaCis study, where patients are screened using the Drug Response Predictor — DRP — as high likely responders before entering the trial,” said Dr. Peter Buhl Jensen, CEO of the Medical Prognosis Institute.

The Drug Response Predictors analyzes a tumor’s genetic signature to predict whether it is likely to  respond to a therapy. Scientists created the tool by comparing the messenger RNA of cancer cells that respond and that resist therapies.

The tool has been tested in 37 trials, 29 of which showed that its biomarkers could accurately predict which patients would respond to treatment.

“Several of the metastatic breast cancer patients are considered hard to treat, with seven to 12 lines of treatment before receiving LiPlaCis,” Jensen said. “We are dedicated to deliver DRPs for the development of new effective treatment options. My expectations are high for the DRP technology, as I believe it will bring new hope and better treatments for cancer patients. For LiPlaCis the goal is to obtain more than a 10 percent response rate.”