Oral Cavity Sustained Release Delivery of Sirolimus for Head and Neck Cancer Treatment

Friedman Michael, HUJI, School of Medicine - IMRIC, School of Pharmacy- Institute for Drug Research
Czerninski Rakefet

Once-daily, sustained-release Sirolimus delivery system


Oral Cavity, Oncology/Cancer, Sustained Release, Drug Delivery

Development Stage

Prototypes tested in vitro; pharmokinetic and pharmacodynamic testing in human volunteers planned

Patent Status



Patients diagnosed with dyspalsia/premalignant cancer lesions estimated as 1% of total population.
The vast majority of the annual 500,000 new squamous cell carcinomas of the head and neck (HNSCC) arise in the oral cavity as oral squamous cell carcinomas (OSCC); poor prognosis due to late diagnosis and failure to respond to available treatment options


  • New sustained-release drug delivery system for preventing and treating oral cancer
  • Potentially malignant lesions in the oral cavity can be detected clinically without any invasive technology; there are no interventional advances that prevent cancer development in these lesions
  • Sirolimus (rapamycin), a macrocyclic lactone isolated from Streptomyces hygroscopicus, is one of the leading agents suggested for preventing and treating OSCC
  • Local sustained oral release of Sirolimus is an effective way of preventing the progression of oral lesions to carcinomas and of treating developed OSCC

Our Innovation

Local, sustained-release oral drug delivery system for early intervention to prevent potentially malignant - premalignant - lesions developing into OSCC and for the treatment of developed OSCC

Key Features

  • System resists harsh conditions in oral cavity
  • System maintains prolonged, local, oral drug delivery
  • Local drug delivery reduces undesired systemic side effects
  • Sustained local oral delivery minimizes the total required drug dose

Development Milestones

Seeking funding for ongoing research

The Opportunity

  • A medical device platform for drugs for the local treatment of oral cancer
  • Accelerated development time and regulatory process

Patent Status

Granted US 10,485,792

Contact for more information:

Mel Larrosa
VP Business Development Healthcare