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Date: 2012-02-02

Type of information:

Product name: talactoferrin

Compound: talactoferrin

Therapeutic area:

Action mechanism: Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis.

Company: Agennix (Germany)

Disease:

malignant neoplasms and other hyperproliferative diseases

 



Latest news: Two Phase III trials with talactoferrin in non small cell lung cancer are ongoing. The FORTIS-M trial is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. Patient recruitment has been completed in March 2011 (See http://biopharmanalyses.fr/clinical-trails/?pageid=514) and data from this trial are expected in July/August 2012.  A second Phase III trial - FORTIS-C - is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients.

Patents: * On March 23, 2011, Agennix AG announced that the U.S. Patent and Trademark Office (USPTO) has issued patent number 7,901,879, entitled, “Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases.”  The patent, which has a term until 2025, covers the use of oral human lactoferrins, including talactoferrin, for the treatment of non-small cell lung cancer (NSCLC) and renal cell carcinoma.
Agennix also reported that a patent application covering the use of talactoferrin in lung cancer has recently received a Decision to Grant in Japan. 

* On August 10, 2011, Agennix announced that the European Patent Office (EPO) has issued patent number 1507554, entitled, “Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases,” covering the use of oral human lactoferrins, including talactoferrin, to treat cancer. It also covers the use of talactoferrin in combination with other therapies, including chemotherapy, immunotherapy, radiation therapy and other treatments. The patent has a term until 2023.

* On July 30, 2012, Agennix AG has announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for patent application US 12/964,327, entitled,  "Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases."  The patent application covers the use of the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin alfa (talactoferrin) for the treatment of non-small cell lung cancer (NSCLC) and renal cancer in combination with chemotherapy, biotherapy, immunotherapy, surgery, radiotherapy, or a combination thereof.

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes