Shares in NetScientific PLC (AIM:NSCI) spiked by more than 6% this morning after the company said it had been fast-tracked for a possible licence by the U.S. Food and Drug Administration.
NetScientific said in a statement today that an immunotherapy drug developed by its portfolio company PDS Biotechnology Corp for the treatment of recurrent or metastatic head and neck cancer has been fast-tracked for approval by the FDA.
The incidence of head and neck cancer has been rising over the past decade and 90% of those associated with HPV are caused by the HPV16 strain.
The drug was trialled in VERSATILE-002 trials in combination with Merck’s anti-PD-1 therapy pembrolizumab (Keytruda) to combat cancers caused by human papillomavirus strain HPV16.
The combination of PDS0101 and Merck's immunotherapy treatment were studied in the second phase of the combination therapy drug trials.
NetScientific said earlier the trial found immunotherapy targeting strain 16 of the human papillomavirus shrank tumour size or stabilised the spread of cancer in 76.5% of patients who took part.
As part of the trials, drugs were injected subcutaneously to activate immune pathways in the patient and trigger patient T cells that target tumours caused by the virus.
The company is carrying out three additional second-phase trials into combating other forms of cancer in partnership with the National Cancer Institute, Mayo Clinic and the University of Texas.
The FDA’s fast-track designation programme aims to expedite drugs that could treat life-threatening conditions and address unmet needs. Drug makers under the fast-track system have closer interaction with the FDA, with the aim of moving promising drugs through the approval process more quickly, and the process allows applications to be submitted on a rolling basis.
These drugs are eligible for a priority review upon application for licensing.
NetScientific's CEO Ilian Iliev said: "The FDA fast track designation of PDS0101 provides recognition that the drug fills an unmet need in a serious condition, with the purpose to get a drug to patients faster."
The company's shares were trading at 93.7p per share at 8:45 am this morning, up from 88p at the last close, after hitting 94.5p in early morning trades.