Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, FDA

Intezyne Technologies Granted Orphan Drug Designation for IT-139 in Pancreatic Cancer

TAMPA, Fla., June 20, 2017 /PRNewswire/ -- Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to IT-139, the most clinically advanced GRP78 inhibitor in development for solid tumors, for the treatment of pancreatic cancer. The FDA's Orphan Drug program provides numerous benefits to support development of promising drugs for rare diseases, including 7-year post-approval market exclusivity, FDA assistance in protocol design, and an exemption from PDUFA fees.

"Our receipt of an Orphan Drug Designation for IT-139 in pancreatic cancer is an exciting regulatory milestone for Intezyne and a critical step towards clinical advancement of this promising first-in-class therapy addressing an unmet need," stated Dr. Carolyn Paradise, Intezyne's Chief Medical Officer. "Pancreatic cancer is currently the fourth most common cancer in the U.S., with approximately 54,000 new diagnoses annually, the majority of which are diagnosed only after their cancer has spread locally and/or metastasized to distant organs. Sadly, pancreatic cancer has proven extremely difficult to treat, with 1-year and 5-year survival rates of only 20% and 8%, respectively ? rates which we hope to improve with IT-139."

The Company's previously completed Phase 1 monotherapy trial of IT-139 showed that it was well-tolerated, with manageable side effects, and successfully demonstrated anti-tumor activity in numerous tumor types. Preclinical studies have shown IT-139's synergy in combination with various other anti-cancer agents including taxanes, platinums, and gemcitabine ? the typical first-line therapies for patients with locally advanced or metastatic pancreatic cancer.

Dr. Suzanne Bakewell, Vice President and Program Manager for IT-139 added, "Since completing our Phase 1 monotherapy trial of IT-139, we have been working with academic collaborators to fully characterize IT-139's mechanism of action (MOA) ? efforts which have yielded exciting results thus far. IT-139 downregulates the stress-induction of GRP78 in cancer cells, a critical cell survival protein that is associated with both drug resistance and tumor proliferation. GRP78 expression is not elevated in the same way in normal cells, leaving them unaffected."

Dr. Kevin Sill, CEO of Intezyne, commented, "Intezyne is currently completing cGMP manufacturing for IT-139 in anticipation of initiating one or more combination Phase 1b/2a studies in 2018. The synergy with low toxicity observed preclinically in combination with existing anti-cancer agents has already generated considerable attention from both investors and potential strategic partners, a number of whom Russell and I will be meeting this week at the 2017 BIO International meeting in San Diego."

For more information, please visit the Company's website at www.intezyne.com.

E. Russell McAllister, CFO 
164938@email4pr.com, (813) 910-2120

SOURCE Intezyne Technologies, Inc.

These press releases may also interest you

at 18:00
The Society of Interventional Radiology debuted the first-ever virtual reality 360 (VR360) training video showcasing interventional radiology in practice, during SIR's Annual Scientific Meeting in Los Angeles. The...

at 10:15
LOS ANGELES, March 17, 2018 /PRNewswire-PRWeb/ -- On Sunday, March 18th, Students Run LA (SRLA) and its 3,200+ runners will be participating in the Skechers Performance Los Angeles Marathon. Each year, SRLA creates a safe, supportive community at 182...

at 07:26
World Happiness Summittm 2018, produced by WOHASUtm LLC welcomed people from over 35 countries and 43 US states to the campus of the University of Miami yesterday. The three-day event opened with lakeside yoga at dawn...

at 00:19
Erie Meat Products Ltd. is recalling Butcher's Selection brand Stampede Chicken Burgers from the marketplace because they may contain egg which is not declared on the label. People with an allergy to egg should not consume the recalled product...

16 mar 2018
Constellation Healthcare Technologies, Inc. ("Constellation" or "the Company"), a healthcare services organization providing outsourced revenue cycle management, practice management, and group purchasing services to U.S. physicians, along with...

16 mar 2018
The Spice Tailor (Canada) Limited is recalling The Spice Tailor brand Fiery Goan Curry from the marketplace because it contains mustard which is not declared on the label. People with an allergy to mustard should not consume the recalled product...

News published on 20 june 2017 at 08:30 and distributed by: