L-DOS47 will be tested in non-small cell lung cancer patient.
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Helix BioPharma has provided updates on progress in its ongoing Topical Interferon Alpha-2b and L-DOS47 product development programs, following pre-investigational new drug (pre-IND) meetings with the FDA.
In order to confirm its plans for future IND filings with the FDA, Helix requested the pre-IND meetings on Topical Interferon Alpha-2b and L-DOS47.
Reportedly, the meetings were held to confirm the specific regulatory requirements for commencing US clinical testing of Topical Interferon Alpha-2b for cervical dysplasia.
The company also discussed requirements by FDA to be met by Helix before gaining approval to begin the next phase clinical tests for L-DOS47 in the US. L-DOS47 will be tested in non-small cell lung cancer patient.
John Docherty, president and CEO of Helix, said: “Our discussions confirmed our expectations of what is necessary to proceed with both clinical programs and we now have a clearly identified path to progress to those clinical investigations.”
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