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26 Sep 2022
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4885
Submission : 1983-03-01
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10261
Submission : 1993-05-26
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Drugs in Development
Details:
Aldoxorubicin, a rationally-engineered cytotoxic delivers well-established anti-cancer agent, doxorubicin, into tumor, utilizes an acid-sensitive linker that selectively binds to albumin, which may allow cytotoxic payload to preferentially accumulate in tumor.
Lead Product(s): Aldoxorubicin HCl,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Cytotoxic Drug
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 20, 2022
Lead Product(s) : Aldoxorubicin HCl,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
CytRx Partners with Oncology Development Expert to Advance LADR Platform
Details : Aldoxorubicin, a rationally-engineered cytotoxic delivers well-established anti-cancer agent, doxorubicin, into tumor, utilizes an acid-sensitive linker that selectively binds to albumin, which may allow cytotoxic payload to preferentially accumulate in ...
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
April 20, 2022
Details:
Through the merger with Centurion, the next-generation LADR drugs including INNO-206, are now within CytRx and poised for the last steps required for first-in-human studies, an achievement that could be expected to generate significant value for shareholders.
Lead Product(s): Aldoxorubicin HCl,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Cytotoxic Drug
Recipient: Centurion BioPharma Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger March 09, 2022
Lead Product(s) : Aldoxorubicin HCl,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Centurion BioPharma Corporation
Deal Size : Undisclosed
Deal Type : Merger
Details : Through the merger with Centurion, the next-generation LADR drugs including INNO-206, are now within CytRx and poised for the last steps required for first-in-human studies, an achievement that could be expected to generate significant value for sharehol...
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Undisclosed
March 09, 2022
Details:
CytRx’s drug candidate, arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in two indications, including Niemann-Pick disease Type C (NPC), and Gaucher disease.
Lead Product(s): Arimoclomol Citrate,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Miplyffa
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2022
Lead Product(s) : Arimoclomol Citrate,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CytRx’s drug candidate, arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in two indications, including Niemann-Pick disease Type C (NPC), and Gaucher disease.
Product Name : Miplyffa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2022
Details:
ImmunityBio continues to study the effectiveness of N-803 and aldoxorubicin in combination with PD-L1 thaNK in Phase 1 / 2 clinical trials to treat triple negative breast cancer and head and neck cancer.
Lead Product(s): Aldoxorubicin HCl,PD-L1 t-haNK,Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 21, 2021
Lead Product(s) : Aldoxorubicin HCl,PD-L1 t-haNK,Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ImmunityBio continues to study the effectiveness of N-803 and aldoxorubicin in combination with PD-L1 thaNK in Phase 1 / 2 clinical trials to treat triple negative breast cancer and head and neck cancer.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 21, 2021
Details:
Phase 2, study will evaluate the comparative efficacy and safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer.
Lead Product(s): Aldoxorubicin HCl,Gemcitabine,Paclitaxel
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Recipient: ImmunityBio
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2021
Lead Product(s) : Aldoxorubicin HCl,Gemcitabine,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : ImmunityBio
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phase 2, study will evaluate the comparative efficacy and safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic p...
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
October 13, 2021
Details:
At 12-months, a significant treatment effect in favor of arimoclomol of −1.40 points was observed, corresponding to a 65% relative reduction in annual disease progression.
Lead Product(s): Arimoclomol Citrate,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Miplyffa
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2021
Lead Product(s) : Arimoclomol Citrate,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
CytRx Highlights Orphazyme’s Published Results From Its Phase 2/3 Trial of Arimoclomol in Nieman...
Details : At 12-months, a significant treatment effect in favor of arimoclomol of −1.40 points was observed, corresponding to a 65% relative reduction in annual disease progression.
Product Name : Miplyffa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 24, 2021
Details:
Enrollment of Cohort C, which includes Aldoxorubicin and patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.
Lead Product(s): Aldoxorubicin HCl,Avelumab,Paclitaxel
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Recipient: ImmunityBio
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2021
Lead Product(s) : Aldoxorubicin HCl,Avelumab,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : ImmunityBio
Deal Size : Inapplicable
Deal Type : Inapplicable
CytRx Highlights Preliminary Results of Cohort C of QUILT 88
Details : Enrollment of Cohort C, which includes Aldoxorubicin and patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first qu...
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 29, 2021
Details:
Orphazyme stated arimoclomol demonstrated a consistent safety profile throughout the 36-month treatment period. Arimoclomol is an investigational drug candidate that amplifies the production of heat-shock proteins (HSPs).
Lead Product(s): Arimoclomol Citrate,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Miplyffa
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2021
Lead Product(s) : Arimoclomol Citrate,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
CytRx Comments on Orphazyme’s Promising 24-Month Interim Trial Results of Arimoclomol for Nieman...
Details : Orphazyme stated arimoclomol demonstrated a consistent safety profile throughout the 36-month treatment period. Arimoclomol is an investigational drug candidate that amplifies the production of heat-shock proteins (HSPs).
Product Name : Miplyffa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 29, 2021
Details:
CytRx has received a Complete Response Letter from the U.S. Food and Drug Administration following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C.
Lead Product(s): Arimoclomol Citrate,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Miplyffa
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 18, 2021
Lead Product(s) : Arimoclomol Citrate,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
CytRx Notes Orphazyme’s Regulatory Update from the FDA on Arimoclomol
Details : CytRx has received a Complete Response Letter from the U.S. Food and Drug Administration following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C.
Product Name : Miplyffa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 18, 2021
Details:
NantKwest and ImmunityBio’s QUILT 88 Trial shows novel combination immunotherapy, which includes which include CytRx’s licensed drug aldoxorubicin, has more than doubled historic median survival rates in patients.
Lead Product(s): Aldoxorubicin HCl,PD-L1 t-haNK,Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Cytotoxic Drug
Sponsor: NantKwest
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 15, 2021
Lead Product(s) : Aldoxorubicin HCl,PD-L1 t-haNK,Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : NantKwest
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : NantKwest and ImmunityBio’s QUILT 88 Trial shows novel combination immunotherapy, which includes which include CytRx’s licensed drug aldoxorubicin, has more than doubled historic median survival rates in patients.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
January 15, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
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