News & Events

May 2017

Rare Pediatric Disease designation for EF-022, for the treatment RRP makes Efranat eligible for a Priority Review Voucher upon approval by FDA

The U.S. Food and Drug Administration (FDA) has granted Efranat Rare Pediatric Disease designation for EF-022, currently being developed for the treatment of Recurrent Respiratory Papillomatosis (RRP). The designation of Rare Pediatric Disease status makes Efranat eligible for a Rare Pediatric Disease Priority Review Voucher upon approval of EF-022 by the FDA.
"This is a very important regulatory and business milestone for Efranat, and we are pleased that that EF-022 for RRP has been granted this status," said Uri Yogev, Efranat’s CEO. "Recurrent respiratory papillomatosis is a rare disease caused by human papillomavirus (HPV) infection of the oral mucosa that manifests as wart-like growths in the respiratory tract. RRP affects both adults and children. RRP presents with different severities and in children, may be life-threatening. Currently there is no cure for this disease which requires repeat surgical interventions, and there is a highly unmet medical need for new potential therapies”.
FDA defines rare pediatric disease as a “serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents”. The designation provides incentives to advance the development of rare disease drugs, including access to the FDA's expedited review and approval programs. In addition, under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval for a new drug application or biologics license application for a rare pediatric disease may be eligible to receive a voucher for a priority review of a subsequent marketing application for a different product. The priority review voucher may be used by the sponsor or sold or transferred.
FDA has also granted Efranat an Orphan Drug Designation (ODD) for EF-022 in RRP. 

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May 2017

FDA Orphan Drug Designation for EF-022 for RRP

The U.S. Food and Drug Administration (FDA) has granted Efranat Orphan Drug Designation for EF-022, currently being developed for the treatment of Recurrent Respiratory Papillomatosis (RRP).

"This is a very important regulatory milestone for Efranat, and we are pleased that EF-022 for RRP has been granted this status," said Uri Yogev, Efranat’s CEO.  "Recurrent Respiratory Papillomatosis is a rare disease caused by human papillomavirus (HPV) infection of the oral mucosa that manifests as wart-like growths in the respiratory tract. RRP affects both adults and children, and may be life threatening in the latter. Currently there is no cure for this disease which requires repeat surgical interventions, and there is a highly unmet medical need for new potential therapies”.

The Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.

FDA has also granted Efranat a Rare Pediatric Disease (RPD) designation for EF-022 in RRP which makes Efranat eligible for a Priority Review Voucher upon approval of EF-022 by the FDA.

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Nov 2015

Dr Talia Golan - Sheba hospital at AACR

Dr Talia Golan from Sheba hospital will present the results of the dose escalation (part of Efranat's study)  at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, at Boston on November 7th, 2015. 

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Oct 2015

Second expanded cohort of Phase I study

Efranat Ltd, a clinical –stage bio-pharmaceutical company focuses on the development and commercialization of EF-022, an immune modulating reagent, for the treatment of cancer and chronic infectious diseases,  announced today that Dr. Talia Golan , Sheba medical Center, Israel, has received final regulatory approval to commence the second part, the expansion cohort, of EF-022 Phase I study in advanced solid malignancies.

 Uri Yogev, Chief Executive Officer of Efranat, stated, "we are extremely pleased that our promising therapeutic candidate is approved to commence the second expanded cohort of the Phase I study of EF-022 in solid tumors. This study is an open label single-center phase I study in patients diagnosed with inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have failed to respond to standard therapy or for whom no standard therapy is available.

 

 

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Aug 2015

Efranat's product name was changed

Efranat's product name was changed to EF-022 

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June 2015

Phase I Dose Escalation completion

Phase I Dose Escalation in 12 patients with solid tumors has been successfully completed with promising results
MTD has not been reached. Treatment was well-tolerated with only mild adverse effects mainly flu like symptoms and rash.
Interesting pharmacodynamics findings were observed and will be further investigated in the next part of the study.
The Dose Expansion part of the study will begin on August 2015 and will include additional 24 patients. 

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Aug 2014

Mr. Oliver Curme joined Efranat's BOD

We are very pleased to announce that Mr.Oliver Curme joined Efranat as member of its board of directors.

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Aug 2014

Mr. Yuval Yanai joined Efranat's BOD

Mr. Yuval Yanai joined Efranat's BOD

We are very pleased to announce that Mr.Yuval Yanai joined Efranat as member of its board of directors. Mr Yanai brings a wide knowledge and experience from the Bio -Pharma, medical devise and High tech industry. Mr Yanai will be a great contribution to our company and team. 

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May 2014

Phase 1 clinical trial initiated

Efranat initiates Phase 1 clinical trial at "Sheba" hospital in Israel.

Enter "Clinical trials web site" 

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March 2014

Israel's Ministry of Health approval

Israel's Ministry of Health approved phase 1 clinical trial in cancer patients with advanced solid tumors to be conducted at the Israeli Sheba Hospital.

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Dec 2013

Sheba hospital IRB approval

The Ethics Committee Review Board of the Sheba Hospital, Israel approved the layout of the phase 1 clinical trial of EF-022 treatment, in cancer patients with advanced solid tumors.

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Oct 2013

Efranat completed GMP production

Efranat has successfully completed production of GMP batches designed for the first phase of the clinical trial. Batches have successfully passed a series of released tests and  will be used in the clinical trial in 2014.

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Aug 2013

Dr. David Sidransky joined Efranat's Board of Directors.

We are very pleased to announce that Dr.David Sidransky joined Efranat as member of its board of directors. Dr. Sidransky’s knowledge and impressive experience as a world renowned oncologist and research scientist will be a great contribution to our company and team. 

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Nov. 2012

Production Agreement with Kamada

Efranat and Kamada signed a production agreement allowing Efranat to produce EF-022 in the cGMP-compliant, FDA-approved, advanced production facilities of Kamada.

 

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Mar. 2012

Efranat Moves to New Expanded Facility

Efranat moved to its new facility in Rehovot Science Park, adjacent to the esteemed Weizmann Institute of Science.

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Nov. 2011

Round of Investment

Efranat has signed an investment agreement with a group of investors led by Dr. Shmuel Cabilly.

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Oct. 2010

Successful Canine Treatment

Exciting results obtained from compassionate treatment on Canines with advanced spontaneous tumors, in collaboration with canine oncologist, Dr. Gillian Dunk of the Koret School of Veterinary Medicine in Israel.

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News & Events

News & Events
  • May 2017

    Rare Pediatric Disease designation for EF-022, for the treatment RRP makes Efranat eligible for a Priority Review Voucher upon approval by FDA

    read more
  • May 2017

    FDA Orphan Drug Designation for EF-022 for RRP

    read more
  • Nov 2015

    Dr Talia Golan - Sheba hospital at AACR

    read more
  • Oct 2015

    Second expanded cohort of Phase I study

    read more
  • Aug 2015

    Efranat's product name was changed

    read more