ASX Health Stocks: Amplia gets FDA green light to commence trial; Recce study meets all primary endpoints

Recce Pharma says study met all all primary endpoints
Amplia gets US FDA IND clearance to commence new pancreatic cancer trial
Imricor also gets approval to start VISABL-AFL clinical trial

Recce’s clinical trial meets all primary endpoints

Recce Pharmaceuticals (ASX:RCE) rose 10% this morning on an update on its Phase I/II diabetic foot infection clinical trial.

The trial assessed the safety and efficacy of RECCE 327 (R327), a broad-spectrum anti-infective, given as a topical treatment on patients with mild skin and soft tissue diabetic foot infections (DFI).

Recce said the study met all primary endpoints, with R327 well-tolerated, and all patients with DFI had their infections resolved or cured following a daily or every second day dosage for 14 days.

Following this success, Recce says it will look to expand clinical sites domestically and internationally, in the interest of accessing a greater patient population.

“We are pleased that the Phase I/II clinical trial has met all primary endpoints, and produced efficacy data to support R327 to be used as topical agent,” said Recce Pharma’s CEO, James Graham.

“We look forward to expanding the study by accessing a global patient population and further enhancing our portfolio of human efficacy data.”

Amplia gets US FDA clearance to commence new trial

Amplia Therapeutics (ASX:ATX) says the US FDA has cleared its Investigational New Drug (IND) Application for a clinical trial of narmafotinib in the US.

The trial will explore the combination of narmafotinib and FOLFIRINOX, in advanced pancreatic cancer patients.

The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, gemcitabine and Abraxane, in advanced pancreatic patients in Australia and South Korea.

In contrast, the IND application reviewed by the FDA today supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer.

“Clearance of the IND by the US FDA is a significant step forward for the company,” says Amplia’s CEO, Dr Chris Burns.

“We will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor.”

“FOLFIRINOX is the preferred treatment for pancreatic patients in the US and most of Europe.

“Therefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer,” said Ward.

Imricor VISABL-AFL clinical trial to start soon

Meanwhile, Imricor Medical Systems (ASX:IMR) announced that the VISABL-AFL clinical trial has been approved by Johns Hopkins Hospital’s Institutional Review Board (IRB).

The first enrolment for the trial is now expected within the next few weeks.

VISABL-AFL is the clinical trial supporting US FDA approval of Imricor’s products.

Imricor’s Chair and CEO, Steve Wedan, said the John Hopkins approval is a major milestone in the company’s FDA approval process.

“As a company, we are pleased that the work that we have quietly gone about over the past 12- 18 months is enabling us to start the year with strong momentum.

“Last week, we secured Saudi FDA approval, and now we have Johns Hopkins IRB approval. Things are coming into place nicely, and we have many more great milestones ahead of us,” said Wedan.

The VISABL-AFL clinical trial will study ablation procedures performed with the IMR’s Vision-MR Ablation Catheter (second generation), HAT 500 RF generator, and irrigation pump.

The study will include sites in the US and Europe.