Anyone Heard Of: "REXIN-G"???

[Rich66]

SAN MARINO, Calif., Oct 06, 2008 /PRNewswire via COMTEX/ -- Epeius Biotechnologies Corporation today announced the publication of another landmark paper describing recent technological advances in medical gene delivery. The latest scientific paper, entitled "Targeting metastatic cancer from the inside: A new generation of targeted gene delivery vectors enables personalized cancer vaccination in situ," was published in the October issue of the International Journal of Oncology (IJO). The paper describes the new state-of-the-art in tumor-targeting biotechnology, nanotechnology, and therapeutic gene delivery developed for clinical applications in the field of oncology. The paper lays the scientific, preclinical and clinical foundations for new applications of personalized medicine, specifically for patients with metastatic cancer.
Based on recent breakthroughs in pathotropic (or disease-seeking) tumor targeting technologies, a new generation of anti-cancer agents is currently being developed. Anti-cancer agents such as Rexin-G can be delivered by simple intravenous infusion, yet are designed to seek out and accumulate in primary and metastatic lesions that have spread throughout the body. Rexin-G is essentially a pathotropically targeted nanoparticle of genetic medicine that is guided by a proprietary targeting technology and is designed to deliver a killer-gene selectively to tumor cells and their associated (proliferative) blood supply. Representing the first and so far only targeted genetic medicine proven to be both safe and effective in the clinic, Rexin-G is commercially available in the Philippines -- for use in all solid tumors that are refractory to standard chemotherapy -- and is currently in clinical trials in the USA for several cancer indications.
Following the validation of its lead product in the clinic, Epeius Biotech has developed a second tumor-targeted anti-cancer agent, named Reximmune-C, designed to work in concert with Rexin-G by providing a localized cancer vaccination aimed at gaining additional tumor control. According to Dr. Erlinda M. Gordon, Medical Director of Epeius Biotech, "Based on the clear survival benefits of Rexin-G that we are seeing in our clinical trials, we felt obligated to advance this new product to provide an opportunity for personalized cancer vaccination in patients who may still be at risk for recurrence." Reximmune-C is a tumor-targeted gene delivery vector delivering an immune-stimulating cytokine gene directly to residual tumors, with the intent of generating a localized vaccination to encourage a lasting anti-tumor immunity. The IJO paper summarizes the preclinical studies, pilot clinical studies, and the elegant vector design engineering embodied in Reximmune-C, which make this clinical application possible.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about our pipeline of proprietary biotechnologies currently available for clinical development and/or new product development, visit us at http://www.epeiusbiotech.com.
For more information about Rexin-G, Reximmune-C, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, contact Dr. Erlinda M. Gordon: egordon@epeiusbiotech.com.
This release was issued on behalf of the above organization by Send2Press(R), a unit of Neotrope(R). http://www.Send2Press.com
SOURCE Epeius Biotechnologies Corporation
http://www.epeiusbiotech.com


Here is the pubmed abstract about combining the somewhat established Rexin-G with Rex-immune C:

1: Int J Oncol. 2008 Oct;33(4):665-75. Links
Targeting metastatic cancer from the inside: a new generation of targeted gene delivery vectors enables personalized cancer vaccination in situ.

Gordon EM, Levy JP, Reed RA, Petchpud WN, Liu L, Wendler CB, Hall FL.
Oncology Research Unit, Epeius Biotechnologies Corporation, San Marino, CA 91108, USA. emgordon@epeiusbiotech.com
The advent of pathotropic (disease-seeking) targeting technologies, combined with advanced gene delivery vectors, provides a unique opportunity for the systemic delivery of immunomodulatory cytokine genes to remote sites of cancer metastasis. When injected intravenously, such pathotropic nanoparticles seek out and accumulate selectively at sites of tumor invasion and neo-angiogenesis, resulting in enhanced gene delivery, and thus cytokine production, within the tumor nodules. Used in conjunction with a primary tumoricidal agent (e.g., Rexin-G) that exposes tumor neoantigens, the tumor-targeted immunotherapy vector is intended to promote the recruitment and activation of host immune cells into the metastastic site(s), thereby initiating cancer immunization in situ. In this study, we examine the feasibility of cytokine gene delivery to cancerous lesions in vivo using intravenously administered pathotropically targeted nanoparticles bearing the gene encoding granulocyte/macrophage colony-stimulating factor (GM-CSF; i.e., Reximmune-C). In vitro, transduction of target cancer cells with Reximmune-C resulted in the quantitative production of bioactive and immunoreactive GM-CSF protein. In tumor-bearing nude mice, intravenous infusions of Reximmune-C-induced GM-CSF production by transduced cancer cells and paracrine secretion of the cytokine within the tumor nodules, which promoted the recruitment of host mononuclear cells, including CD40+ B cells and CD86+ dendritic cells, into the tumors. With the first proofs of principle established in preclinical studies, we generated an optimized vector configuration for use in advanced clinical trial designs, and extended the feasibility studies to the clinic. Targeted delivery and localized expression of the GM-CSF transgene was confirmed in a patient with metastatic cancer, as was the recruitment of significant tumor-infiltrating lymphocytes (TILs). Taken together, these studies provide the first demonstrations of cytokine gene delivery to cancerous lesions following intravenous administration and extend the applications of cancer immunization in vivo.

[hutchibk]

Thanks Rich - I have been lurking on this discussion and I appreciate the recent update...

[Rich66]

I'd love to see this trial be helpful to someone near to CA.

[Rich66]

Rexin-G Returns to The Big Apple: Clinical Trials for Pancreatic Cancer and Breast Cancer Open in Manhattan





Last update: 3:54 p.m. EDT Oct. 29, 2008


SAN MARINO, Calif., Oct 29, 2008 /PRNewswire via COMTEX/ -- Epeius Biotechnologies Corporation announced today the expansion of clinical trials using intravenous Rexin-G for pancreatic cancer and breast cancer in Manhattan, New York. Rexin-G is the world's first tumor-targeted genetic medicine that is designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. Clinical data from on-going studies in Los Angeles, California, indicating dose-dependent tumor control rates and survival benefits with no major toxicity in Rexin-G-treated patients prompted the extension of these clinical trials to the East Coast. Rexin-G has gained orphan drug status from the U.S. FDA for three clinical indications: pancreatic cancer, osteosarcoma and soft tissue sarcoma.
The New York clinical trials will be conducted at the Bruckner Oncology Center in Manhattan, New York with Howard W. Bruckner, M.D. as the Principal Investigator. Dr. Bruckner is a board certified medical oncologist who trained at Yale University School of Medicine and performed research at the NIH with specialists and collaborative groups. Dr. Bruckner is internationally renowned for his work in pancreatic, breast, gastrointestinal, colon, and ovarian cancers and was the first medical oncologist to treat patients with Rexin-G for advanced pancreatic cancer in the United States (Int'l J Oncol 2006). He has served as an Expert Consultant and Safety Monitor for the National Surgical Adjuvant Project for Breast and Bowel Cancers Project (NSABP) sponsored by the National Cancer Institute. For further information concerning these clinical trials in New York, please go to http://www.clinicaltrials.gov and search Epeius-sponsored protocols C07-104 and C07-105.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for outlicensing and clinical development, please visit us at http://www.epeiusbiotech.com.

[Believe51]

I have tears running down my face reading this news. Thank you friend. May this be another drug we can arm our selves with if need be. Solute!!>>Believe51

[Rich66]

PET/CT used in study of Rexin-G for pancreatic cancer

SNM SmartBrief | 10/15/2008
PET/CT showed a decrease in metabolic activity in tumors in a clinical trial of Rexin-G for patients with pancreatic cancer. "I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G," said the principal investigator in a news release. Earthtimes.org (04/21)

[Rich66]

Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients With Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)
by Barry Sugarman on Tue 03 Jun 2008 11:25 PM PDT | Permanent Link
Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients With Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)


SAN MARINO, Calif., May 29, 2008 -- Epeius Biotechnologies

(http://www.epeiusbiotech.com) announced today the results of an on-going Phase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (J Clin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targeted gene therapy vector that has been tested in the clinic (Nature Reviews/Genetics 2007). In this open label study, cohorts of 6 to 7 patients with all types of sarcoma, including osteosarcoma, Ewing's sarcoma, leiomyosarcoma, malignant fibrous histiocytoma, chondrosarcoma, fibrosarcoma, liposarcoma, angiosarcoma, spindle cell sarcoma, and malignant mixed Mullerian tumor of ovary, were treated with 1 x 10e11 cfu Rexin-G, administered i.v. over 5 minutes, 2 times a week for 4 weeks (Cumulative Dose = 8 x 10e11 cfu) followed by a 2-week rest period. Patients with Grade 1 or less toxicity were given progressive intra-patient dose-escalations consisting of additional treatment cycles of 1 to 2 x 10e11 cfu three times a week for 4 weeks (Cumulative Dose per cycle: 1.2-2.4 x 10e12 cfu).


These higher dosing regimens were associated with prolonged disease stabilization and a median overall survival of greater than 6 months, which was three times longer than that observed in the low-dose group. Further, histologic examination of resected tumors showed 50-90% necrosis. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated. Taken together with previous clinical studies conducted in the Philippines and Japan, these studies confirm the exemplary safety and dose-dependent efficacy of Rexin-G in a broad spectrum of chemotherapy-resistant cancers.


For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at . egordon@epeiusbiotech.com

[Rich66]

PRESS RELEASE
Rexin-G Controls Tumor Growth and Improves Survival in Chemotherapy-Resistant Soft Tissue Sarcoma and Osteosarcoma: Phase I/II & Confirmatory Phase II Studies






Last update: 8:49 p.m. EST Nov. 20, 2008







SAN MARINO, Calif., Nov 20, 2008 /PRNewswire via COMTEX/ -- Epeius Biotechnologies announced today the results of Phase I/II and II studies of Rexin-G in chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma, as presented by Dr. Sant P. Chawla, principal investigator, at the CTOS 14th annual meetings held in London UK on November 13-15, 2008. Patients received repeated infusions of Rexin-G i.v. over a period up to 9 months. Analysis of safety and efficacy data showed no major toxicity, while documenting significant control of tumor growth.
Analysis of efficacy in 42 patients with bone and soft tissue sarcoma showed a dose-response relationship between overall survival and Rexin-G which was highly significant. A confirmatory Phase II study in 17 osteosarcoma patients showed a median overall survival greater than seven months; that is, after failing standard chemotherapies. Two patients are disease-free greater than 6 months after surgical resection of residual tumors and Rexin-G given as both neoadjuvant and adjuvant monotherapy. These studies indicate that (i) intravenous Rexin-G is safe and well-tolerated, and (ii) Rexin-G controls tumor growth and improves survival in a dose-dependent manner in patients with chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma.

[Believe51]

Thank you so very much for following this drug for Mom as well as all of us. You rule!!>>Believe51

[donocco5w4]

I did some research on Rexin G. The info is complicated and involves understanding the interaction between Cyclin G1, a protein called ARF and another protein Called MDM2. Apparently ARF and MDM2 act against the tumour destroying P53 protein and Cyclin D1 binds to these proteins. This would at first make it seem, at least to me, that the more Cyclin D1 the cancer cells contain, the better but apparantey this isnt true.

Rexin G seems to carry an inactive Cyclin G1 gene on a virus to replace the active Cyclin G1 gene in the cancer cells. Thus when the cancer cells cyclin G1 gene is replaced by the inactive gene in
Rexin G you get the very positive results mentioned. There have been long standing remissions in a few cases of pancreatic cancer. I need to do more research to really understand how Rexin G works as I am a pharmacist not a cancer genetecist. It does look hopeful though

Paul

[Rich66]

Epeius Bio Awarded Patents in Europe for Targeted Genetic Anti-Cancer Medicine

Wed, 17 Dec 2008 14:00:46 -0800 PST
by Tabitha Berg

SAN MARINO, Calif. — Epeius Biotechnologies Corporation, a leader in tumor-targeted gene delivery systems, has received two additional European patents for the platform targeting technologies and molecular designs that enable precision gene delivery to primary cancers and metastatic lesions that have spread throughout the body. With profound demonstrations of clinical benefit and single-agent-efficacy, as well as overall safety, Epeius Biotech continues to lead the field of clinical gene medicine with the advent of pathotropic (or disease-seeking) targeting. These latest EU patents follow on the heels of a major clinical patent that was recently awarded in the USA for targeted gene delivery in vivo.
Together these clinical patents provide additional intellectual property protection for the platform of highly advanced biotechnologies embodied in the company’s leading anti-cancer agent Rexin-G(R) — the first and so far only tumor-targeted gene delivery system that has been successfully validated in the clinic.
Based on recent breakthroughs in tumor-targeting and nanotechnology, a new generation of powerful biological anti-cancer agents that are exceedingly precise and highly selective for diseased tissues is currently in clinical development. Anti-cancer agents such as Rexin-G(R) can be delivered by simple intravenous infusion, yet are programmed to seek-out and accumulate selectively in primary and metastatic lesions that have spread throughout the body, delivering a tumor-killing gene while sparing normal cells and tissues.
Representing the world’s first targeted genetic medicine proven to be both safe and effective in the clinic, Rexin-G(R) is commercially available in the Philippines-for use in all solid tumors that are refractory to standard chemotherapy-and is currently in clinical trials in the USA for several types of cancer.

[Rich66]

http://send2press.com/newswire/print...0119-002.shtml

Rexin-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer
Edited by Carly Zander
Mon, 19 Jan 2009, 20:32:23 EST


Analysis of a U.S. Phase I/II Clinical Trial (Proceedings of ASCO GI Symposium 2009)

SAN MARINO, Calif., Jan. 19 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (epeiusbiotech.com) announced the results of a U.S. Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic pancreatic cancer (ASCO GI Symposium, #249; Sant P Chawla, P.I., Santa Monica CA, January 2009). Rexin-G was well tolerated and there was no dose-limiting toxicity. At Dose Level I, three patients achieved stable disease with no tumor progression; and at Dose Level II, one patient had a 37 percent decrease in tumor size and five patients exhibited disease stabilization with no tumor progression.

Importantly, Rexin-G improved patient survival in a dose-dependent manner: At Dose Level I, median progression-free survival was 3 months, and median over-all survival was 5 months, while at Dose Level II, median progression-free survival was greater than 3 months, and median over-all survival was greater than 9 months.

By direct comparison with a prior low-dose Phase I safety study (Galanis et al. 2008), the new "effective doses" of Rexin-G nearly tripled the overall survival time. Thus, this current Phase I/II study defines a critical pharmacological "threshold" for Rexin-G bioactivity in the treatment of metastatic pancreatic cancer.

The present study confirms the overall safety of Rexin-G, and further demonstrates that Rexin-G monotherapy, at these defined dose levels, exhibits profound anti-tumor activity that prolongs both progression-free survival and over-all survival time in pancreatic cancer patients that had previously failed standard chemotherapy.

Rexin-G® is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. The FDA has granted Orphan Drug Status for Rexin-G for the treatment of (i) pancreatic cancer, (ii) osteosarcoma, and (iii) soft tissue sarcoma, while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its tumor-targeted gene delivery systems. To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

More information online: www.epeiusbiotech.com.

[Believe51]

Rich, funny you should pull this post up today since I was going to myself. The wonderful mom that came into my office and got this seed planted in my head in the first place visited me yesterday.

She was on a plight to get this drug to be used in clinical trials on the east coast. Done. She worked with Dr Gordon and Rexin-G studies, clinical trials and the FDA. I will post later more important information about where it is on the FDA ladder and who is using this outside of clinical trials.

Mom, named Rose, has lost her home to her mission to save her son who has since passed. His name was Chris and it is in his honor that Rose has chosen me to be on her volunteer staff; I feel honored!! Maybe she lost her son and home, but Rose has not lost her battle.

She is working to get the balls rolling and to allow the average Joe to afford this. She has employed a lawyer to help her efforts to properly get balls rolling. Rose wants to start a program to get this to everyone who needs it. This drug is being used outside of clinical trials by some brazen doctors.

So, after another conversation with Rose I will post these doctors. Rexin-G was designed for pancreatic cancer but is being utilized by breast and ovarian cancer patients. Since June many wonderful things have happened and there is still more to come.

Working in a newspaper I must be careful of what news I can release right now. Soon to follow will be the press releases of vital information. I will provide as much information as I am legally allowed to at this moment.

Things are rolling forward. Even Rose says never think our voices have no sound. I am so proud of her, she took a hard situation and made it come true. Hang in there Warriors because each day we get on step closer to wonderful drugs that may help us in our own plights.

I am so excited!! We have a major project scheduled for next week. Right now Rose is trying to start a fund for the patients who have no medical or are falling between the cracks! So far this fund could finance another home for her. Nope, not Rose, for she does not want another home. She wants this dream to come true.....so far it is.

Please think of her as she works with this lawyer, the FDA, Dr Gordon and the drug company. I cannot wait to give her back some of the hope she has given to people she will never meet. Wish me luck, looks like this little lady will be keeping me busy. I have even postponed my breast cancer mission in Washington to see her through.

So Chris.....this is all in your honor. Although we never met and never will, I advocate this matter in your honor!>>Believe51

[Mary Anne in TX]

Oh, Marie, you'll meet, butterfly!!!!
Just not now!
There is still work for you here!
ma

[Rich66]

Didn't anticipate any response when I posted that. I do wish you mucho luck with your/her efforts. Let me know if I can help.

[Rich66]

Psst. Any news fit for public consumption?

[Believe51]

Rich, will post soon.

On another note, Rose has many projects scheduled and we will need your help. I thank you so much for offering your services. This is going to be huge!

She is not going to work on just the Rexin-G projects. Rose is starting a foundation involving clinical trials.....HUGE! I never dreamed that she would take me onboard and I feel honored to help. When she gets really into the process, Marie may just have another full-time job. Ah.....cannot blame a girl for dreaming! Wink!

Will post soon, many things that might be too in depth. Do not worry though, I am sure we can de-code everything with the help of this intelligent family!

Off to research>>Believe51

[Rich66]

nag, nag , nag

[jones7676]

I guess I will be busy reading tonight!

[Rich66]

Video that illustrates the 1, 2 punch of Rexin-g and Rex immune C. Fun to watch cancer necrotizing..is that a word? Ahem.
http://www.epeiusbiotech.com/oncology-video.asp