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Details:
The objective of this pilot study is to assess microcatheter-based delivery of CypCaps in the pancreatic arterial system. volume of dose, number of CypCaps, and treatment location will be evaluated using imaging and histology.
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: CBSET
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2022
Details:
The study has achieved positive interim results in its study to establish a malignant ascites mouse model which will form the basis for further testing of the effectiveness of its CypCaps plus ifosfamide pancreatic cancer therapy for the treatment of malignant ascites.
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Heidelberg Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Analysis after 18 months in storage at -80oC, the unfrozen CypCaps product passed all the specified tests, including cell viability, enzyme activity, cell potency, pH, label check, capsule appearance and integrity.
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
PharmaCyte is positioned to immediately move into a fully funded clinical trial in LAPC should the FDA lift the clinical hold.
Lead Product(s): Encapsulated Live Cells,Ifosfamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $90.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 25, 2021
Details:
The Company intends to use the net proceeds of this offering to complete activities requested by the U.S. Food and Drug Administration (FDA) to address the FDA’s clinical hold on its Investigational New Drug application (IND).
Lead Product(s): Encapsulated Live Cells,Ifosfamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: H.C. Wainwright
Deal Size: $70.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 23, 2021
Details:
PharmaCyte's CypCapsTM, is a genetically engineered human cells encapsulated using the Cell-in-a-Box® technology. PharmaCyte is conducting a Phase 2b study to evaluate the efficacy and safety of CypCaps in combination with low-dose ifosfamide vs chemoradiation therapy.
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: H.C. Wainwright
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 09, 2021
Details:
The DMF provides all confidential and detailed information covering the production of the CypCaps™ final product, which was produced by Austrianova and will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
PharmaCyte has successfully completed development of the “change history” information and data for CypCaps™ (2nd generation product) compared to CapCell™ (1st generation product).
Lead Product(s): CypCaps,Ifosfamide
Therapeutic Area: Oncology Product Name: CypCaps
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
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