Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2l-OCT-01 PR, Administered Intra Muscularly Every 4, 5 or 6 Weeks in Acromegalic Patients

The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.

Start Date01 Feb 2008

Sponsor / Collaborator

Ambrilia Biopharma, Inc.

EUCTR2007-004320-21-HU / Not yet recruitingNot Applicable

OPEN LABEL EXTENSION STUDY EVALUATING THE SAFETY AND BIOLOGICAL ACTIVITY OF A NEW PROLONGED RELEASE FORMULATION OF OCTREOTIDE ACETATE, C2L-OCT-01 PR, ADMINISTERED INTRA MUSCULARLY EVERY 6 WEEKS IN ACROMEGALIC PATIENTS

Start Date29 Oct 2007

Sponsor / Collaborator

Ambrilia Biopharma, Inc.

NCT00635765 / CompletedPhase 3

Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients

The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.

Start Date01 Oct 2007

Sponsor / Collaborator

Ambrilia Biopharma, Inc.

100 Clinical Results associated with Ambrilia Biopharma, Inc.

0 Patents (Medical) associated with Ambrilia Biopharma, Inc.

Literatures (Medical) associated with Ambrilia Biopharma, Inc.

01 Feb 2016·Bioorganic & Medicinal Chemistry LettersQ4 · MEDICINE

Pyridoxine hydroxamic acids as novel HIV-integrase inhibitors

Q4 · MEDICINE

Article

Author: Xiao, Yong ; Mouscadet, Jean-François ; Wang, Zhigang ; Garde, Seema ; Wu, Jinzi J ; Forte, André ; Delelis, Olivier ; Milot, Guy ; Bouchard, Jean-Emanuel ; Beaulieu, Françis ; Stranix, Brent R ; Gouveia, Kristine

A series of pyridoxine hydroxamic acid analog bearing a 5-aryl-spacers were synthesized. Evaluation of these novel HIV integrase complex inhibitors revealed compounds with high potency against wild-type HIV virus.

15 Nov 2008·Clinical Cancer ResearchQ1 · MEDICINE

Enhanced Antitumor Efficacy of Clinical-Grade Vasculature-Targeted Liposomal Doxorubicin

Q1 · MEDICINE

Article

Author: Neumaier, Carlo E. ; Pastorino, Fabio ; Daga, Antonio ; Garde, Seema V. ; Ponzoni, Mirco ; Wu, Jinzi J. ; Longhi, Renato ; Ribatti, Domenico ; Pagnan, Gabriella ; Corti, Angelo ; Nico, Beatrice ; Di Paolo, Daniela ; Brignole, Chiara ; Loi, Monica ; Baio, Gabriella ; Lepekhin, Eugene A. ; Allen, Theresa M. ; Marimpietri, Danilo ; Cilli, Michele ; Piccardi, Federica

AbstractPurpose: In vivo evaluation of good manufacturing practice-grade targeted liposomal doxorubicin (TVT-DOX), bound to a CD13 isoform expressed on the vasculature of solid tumors, in human tumor xenografts of neuroblastoma, ovarian cancer, and lung cancer.Experimental Design: Mice were implanted with lung, ovarian, or neuroblastoma tumor cells via the pulmonary, peritoneal, or orthotopic (adrenal gland) routes, respectively, and treated, at different days post inoculation, with multiple doses of doxorubicin, administered either free or encapsulated in untargeted liposomes (Caelyx) or in TVT-DOX. The effect of TVT-DOX treatment on tumor cell proliferation, viability, apoptosis, and angiogenesis was studied by immunohistochemical analyses of neoplastic tissues and using the chick embryo chorioallantoic membrane assay.Results: Compared with the three control groups (no doxorubicin, free doxorubicin, or Caelyx), statistically significant improvements in survival was seen in all three animal models following treatment with 5 mg/kg (maximum tolerated dose) of TVT-DOX, with long-term survivors occurring in the neuroblastoma group; increased survival was also seen at a dose of 1.7 mg/kg in mice bearing neuroblastoma or ovarian cancer. Minimal residual disease after surgical removal of neuroblastoma primary mass, and the enhanced response to TVT-DOX, was visualized and quantified by bioluminescence imaging and with magnetic resonance imaging. When treated with TVT-DOX, compared with Caelyx, all three tumor models, as assayed by immunohistochemistry and chorioallantoic membrane, showed statistically significant reductions in cell proliferation, blood vessel density, and microvessel area, showing increased cell apoptosis.Conclusion: TVT-DOX should be evaluated as a novel angiostatic strategy for adjuvant therapy of solid tumors.

16 Nov 2007·Blood

Synthetic 15-mer Peptide (PCK3145) Derived from Prostate Secretory Protein with In Vitro and In Vivo Activity Against Non-Hodgkin’s Lymphoma and Other Hematologic Malignancies.

Author: Roy, Denis-Claude ; Therien, Cynthia ; Dulude, Helene ; Krosl, Gorazd ; Wu, Jinzi J. ; Panchal, Chandra ; Guerin, Mireille

AbstractProstate secretory protein 94 (PSP-94) has been shown to exert anti-tumor activity against prostate cancer cells, particularly in the form of PCK3145, a synthetic peptide corresponding to amino acids 31–45 of PSP-94. Indeed, when tested in a murine model, this peptide could reduce experimental prostate tumour growth. In addition, when evaluated in a Phase I clinical study, this peptide demonstrated a particularly interesting safety profile, with almost complete lack of toxicity. In order to determine whether PCK3145 could exert cytotoxic activity against other marrow infiltrating cancers, we tested its activity both in vitro and in vivo against non-Hodgkin’s lymphoma (NHL) and other hematologic cancers. Interestingly, PCK3145 inhibited the proliferation of human NHL (SR) and myeloma (RPMI-8226) cell lines in vitro. To explore its anti-tumor activity in vivo, the impact of PCK3145 was also measured by inoculating P815 malignant cells into syngeneic DBA mice. First, four groups of 6 DBA mice were injected subcutaneously with 2x104 P815 cells and then treated with subcutaneous injections of PCK3145, and compared toa peptide with the scrambled amino acid sequence, PCK5266 (peptide derived from amino acids 52 to 66 of PSP-94), and phosphate-buffered saline (PBS).Treatment with PCK3145 significantly decreased the growth of P815 tumours in comparison to PBS (p<0.001), scrambled peptide (p<0.05) and PCK5266 (p<0.01), confirming in vivo anti-tumor activity and suggesting that tumour growth inhibition is due to the specific amino acid sequence of PCK3145. The same model was used to determine the effect of PCK3145 on metastatic dissemination following intraperitoneal administration of the peptide. PCK3145 treatment led to a decreased number of liver metastasis compared to PBS (p<0.05) and scrambled peptide (p<0.05) controls. In order to determine whether PCK3145 exerted its activity by altering metalloproteinase release, metalloproteinase MMP-9 levels were measured 3 weeks post-tumor cell exposure. MMP-9 levels, measured by ELISA, in the peripheral blood of treated P815 bearing mice were similar to those obtained with healthy animals (12.83±1.890 (mean±SD) ng/ml and 7.183±0.4070 ng/ml, respectively), while MMP-9 levels were elevated in mice treated with PBS and scrambled peptide (35.12±8.559 ng/ml and 22.60±3.944 ng/ml, respectively; p<0.05). We next tested PCK3145 treatment on human SR lymphoma cell line grown subcutaneously in NOD/SCID mice. Similarly to results obtained with murine tumors, treatment with PKC3145 resulted in significant inhibition of SR non-Hodgkin’s lymphoma growth compared to treatment with PBS (p<0.001) and scrambled peptide (p<0.01). These results demonstrate that in vivo treatment with PCK3145 can reduce tumor cell proliferation of both murine and human hematologic cancers. In addition, PCK3145 has the potential to inhibit tumor cells dissemination by lowering MMP-9 secretion. Thus, PCK3145 represents a unique peptide demonstrating sequence-specific anti-tumor activity against NHL and other hematologic malignancies. Based on these results, clinical studies are being designed to evaluate its therapeutic activity in humans.

100 Deals associated with Ambrilia Biopharma, Inc.

100 Translational Medicine associated with Ambrilia Biopharma, Inc.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

TVT-DOX ( APN )	Solid tumor More	Preclinical
C2L-OCT-01 PR	Acromegaly More	Discontinued
Putrescine dihydrochloride ( TGM2 )	Cicatrix, Hypertrophic More	Discontinued
M2 proton channel inhibitors(Ambrilia Biopharma, Inc.) ( M2 protein )	Influenza A virus infection More	Discontinued
C-2C5	Neoplasms More	Pending

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