Rexin-G

Rich66 · 11-05-2009, 01:33 AM

http://www.epeiusbiotech.com/

Rexin-G^® - Tumor-Targeted Injectable Genetic Medicine

About Rexin-G^®

Scientists at Epeius Biotechnologies have developed the high-technologies that can deliver a new class of powerful biological agents directly to tumors that have spread throughout the body (metastatic cancer). The lead product, Rexin-G, is a sophisticated gene delivery vehicle (or vector); a tumor-targeted nanoparticle that is programmed to deliver a tumor-killing designer gene precisely where it is needed most. Rexin-G has been validated in international clinical trials, where it is shown be highly active against a broad spectrum of chemo-resistant tumor types, causing tumor shrinkage in patients suffering from metastatic cancer, without causing dose-limiting toxicity or organ damage.
Technically, Rexin-G is a matrix-targeted nanoparticle that seeks out the biochemical hallmarks of pathology (pathotropic targeting), accumulates to high levels in tumors, and delivers a cytocidal (lethal) gene construct: a dominant-negative construct of the human Cyclin-G1 gene, a pivotal cell cycle control element. The capsule containing the therapeutic dnG1 gene is based on a murine retroviral core, which is devoid of viral genes and has been rendered certifiably replication incompetent—that is, it capable of delivering a therapeutic gene once, and only once. The integral tumor-targeting function is indeed profound, in that it is capable of penetrating primary and metastatic cancers, as well as cancers within the lymphatic system, with high efficiency, within a matter of hours, which represents the half-life of the active anti-cancer agent.

Cancer patient beating the odds

By Dan Abendschein, Staff Writer
Posted: 05/13/2009 08:25:05 PM PDT

Last summer, Ruth Oliver was prepared to tell her friends and family goodbye and live out in peace the seven months her doctor had estimated she had left.
Today, she says she feels healthier than she did before she was diagnosed with pancreatic cancer, thanks to a local medical research team that has come up with a new treatement.
"They've extended my life and given me a better quality of life," said Oliver, a 73-year-old North Carolina native who is now living in Southern California to receive treatment.
The drug, called Rexin-G, was developed by a San Marino-based firm. It is now going through the clinical trial phase and has not yet been approved by the Federal Drug Administration.
The treatment, which is administered by intravenous drip three times a week, is designed to minimize tumors that chemotherapy cannot destroy.
Oliver has several such tumors: she may never be rid of them, but so far, the drug has helped keep them under control.
A career mortgage broker in the Durham area, Oliver was generally healthy until one Saturday in 2006 she found herself extremely itchy - a maddening symptom that bothered her to the point of going to the emergency room. Her doctors diagnosed her with pancreatic cancer.
She had surgery for her tumors and then had several bouts of chemotherapy and raditation treatements which left her exhausted, but still not rid of cancer.
"I could hardly lift my foot off the floor and walk, I was so tired," said Oliver. Last summer, her doctor in Durham noted that the latest chemo session still had not rid her of tumors, and that she would not live for more than six to seven months. But he suggested she investigate new cancer treatments being developed.
Oliver did extensive Internet research, and finally came across Epeius Biotechnologies, the San Marino firm that developed Rexin-G. She gets her treatment at a Santa Monica clinic, and is now living in Marina Del Rey.
The drug is part of a new kind of medical treatment called gene therapy. The Rexin-G treatment involves a specially-designed gene that interacts with cancerous cells.
Dr. Maria Gordon, the co-founder of Epeius who helped develop the drug, describes it as a "guided missle."
"It knows where to go," said Gordon. "It targets the cancer cells and gives them a self-destruct order."
The drug, she said, tells the cancer cells to stop reproducing, stopping their growth and their influence on the body.
The gene in the drug is designed to move into areas where there are cancerous cells, and to avoid areas where there aren't any.
It could be used by patients with all kinds of cancer , said Gordon.
The drug has testing status from the FDA, and Oliver is one of the patients undergoing clinical trials to see if it is effective.
Living in California has been an adjustment for Oliver, but she has visited the area before and is enjoying the weather, and the chance to live somewhere new.
Her apartment is within walking distance of the beach, something Oliver takes advantage of. "I'm just glad to have a chance to live in such a beautiful area," said Oliver, of her new home in Southern California.
dan.abendschein@sgvn.com
(626) 962-8811, Ext. 4451

Drugs and Pharmaceuticals News

PRESS RELEASE:

Tumor-Targeted Nanoparticle-based Gene Delivery Provides Evidence of Therapeutic Vaccination in Patients with Metastatic Cancer (ASCO 2010)
Mon, 24 May 2010, 13:06:41 EDT

SAN MARINO, Calif. (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation (www.epeiusbiotech.com) today announces the clinical results of the study entitled "A Phase I/II Study of Intravenous Rexin-G and Reximmune-C for Cancer Immunotherapy: The GeneVieve Protocol" at the ASCO Annual Meeting on June 6, 2010. The presentation will be made by Dr. Jorge G. Ignacio, Chairman of the Cancer Institute and Bioethics Committee-Philippine General Hospital, and Principal Investigator of the study.

SUMMARY: Rexin-G and Reximmune-C are tumor-targeted retrovectors bearing a cytocidal anti-cyclin G1 construct and a controllable GM-CSF expression construct, respectively. The working hypothesis underlying this two-tier complementary approach to tumor eradication and cancer vaccination is that a personalized vaccination of a patient against his or her own specific cancer can be achieved by combining (1) a targeted vector bearing a tumoricidal payload, i.e. Rexin-G, with (2) a targeted vector bearing a potent immuno-stimulatory (GM-CSF) gene, i.e. Reximmune-C. In this model, Rexin-G is first administered to control tumor growth and expose neoantigens within the tumor microenvironment, followed by defined pulses of Reximmune-C, intended to recruit the patient's immune cells into these lesions, thereby prompting immunologic activation, recognition of tumor neoantigens, and induction of a beneficial antitumor immunity. The initial results of a Phase I/II dose escalation study showed that, in addition to the expected tumoricidal effects of Rexin-G, histopathologic examination of biopsied tumors from patients with a diversity of cancer types revealed targeted nanoparticle delivery, GM-CSF transgene expression, and localized immune responses within the lesions. Importantly, no circulating GM-CSF protein was detected and no dose limiting toxicity was observed throughout the treatment period. Moreover, there appears to be a significant survival benefit which suggests that this two-tier approach has considerable merit as a therapeutic vaccine.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation (www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems. To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon @ epeiusbiotech.com .

Rich66 · 11-05-2009, 01:34 AM

Rexin-G Controls Tumor Growth And Improves Survival In Chemotherapy-Resistant Sarcoma And Osteosarcoma: Phase I/II And Phase II Studies, ASCO 2009

19 May 2009

Epeius Biotechnologies announced the results of two related studies using Rexin-G, a tumor-targeted anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body. While Rexin-G is currently approved for the treatment of all solid tumors in the Republic of the Philippines, Epeius Biotech is conducting a series of advanced Phase I/II studies and a Phase II confirmatory trial in the U.S. The Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic bone and soft tissue sarcomas (ASCO Annual Meeting 2009, #10513) demonstrated that Rexin-G was well-tolerated with no dose-limiting toxicity. Moreover, Rexin-G exhibited dose-dependent efficacy in terms of tumor control rates, progression-free survival, and overall survival, thus validating both the efficiency of the tumor-targeting technology and the pharmacological mechanisms of action.

The efficacy and safety of Rexin-G was further confirmed in a Phase II study for chemotherapy-resistant osteosarcoma. Again, in the absence of dose-limiting toxicity, Rexin-G was demonstrated to control tumor growth, prolong progression-free survival, and improve overall survival in osteosarcoma patients who have failed known therapies. It is important to note that these outstanding results, were achieved when Rexin-G was administered as monotherapy-unlike many other so-called targeted biologics where one or more toxic agents are used in combination in order to achieve even marginal results. Based on a critical analysis of its performance in the clinic, the U.S. FDA recently granted Rexin-G Orphan Drug Status for both soft tissue sarcoma and osteosarcoma. The results of these studies will be presented by Dr. Sant P. Chawla, Sarcoma Oncology Center, Santa Monica, CA, and discussed by Dr. Katherine Janeway, Dana-Farber Cancer Institute, Boston, MA on Saturday, May 30, 2009 at 5:00 p.m. EST/EDT.

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 high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine.

Source: Epeius Biotechnologies Article URL: http://www.medicalnewstoday.com/articles/150482.php
Main News Category: Bones / Orthopaedics
Also Appears In: Cancer / Oncology, Pharma Industry / Biotech Industry, Clinical Trials / Drug Trials,

Epeius Biotechnologies' Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer
Edited by Debra Tone
Wed, 17 Jun 2009, 06:00:17 EDT

SAN MARINO, Calif., June 17 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today that its lead product, Rexin-G®, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use as a second-line treatment for advanced or metastatic pancreatic cancer. The FDA Fast Track program, like Priority Review and Accelerated Approval, was implemented to facilitate the development and expedite the review of potentially important new drugs.

The Fast Track Product designation, in particular, is granted following a critical evaluation of the "seriousness" or life-threatening nature of the unmet medical need, namely pancreatic cancer, and the potential of Rexin-G and its progressive clinical development to address this unmet need.

"This is an excellent affirmation of all that we have worked for," says Dr. Erlinda Maria Gordon, Medical Director of Epeius Biotechnologies, "and an important validation of our medical mission." Indeed, Rexin-G is the first in an entirely new class of targeted anti-cancer agents, with a sophistication that goes well beyond a simplistic antibody. Rexin-G is the flagship of tumor-targeted genetic medicine: "smart," "stealth," "selective" and "potent" nano-medicine that not only seeks out and accumulates in cancerous lesions that have spread throughout the body, but delivers a tumor-killing designer gene where it is needed most, selectively destroying tumor cells and their attendant blood supply, while sparing normal cells and healthy tissues.

As presented at the 2009 ASCO G.I. Symposium, "Rexin-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer," documenting survival benefits, without toxicity, as monotherapy, when all else fails.

The FDA's timely decision to grant Rexin-G Fast Track Product Designation is not only validating in terms of the potential of this Investigational New Drug to meet an unmet medical need, but it reflects on the design and integrity of the clinical development program of Epeius Biotechnologies. "It took years of sustained effort, but our decision to firmly establish the overall safety of repeated infusions of Rexin-G in early-stage clinical trials, before we moved on to progressively higher doses, has served us well," said Dr. Gordon. "For it was in determining the actual needs of our patients, in concordance with ongoing FDA guidance, that eventually achieved the control of tumor growth and metastasis," she added.

Remarkably, the adaptive designs of the strategic dose-escalation studies not only served to confirm the overall safety of Rexin-G and the lack of either systemic or dose-limiting toxicity, but it served to establish the critical thresholds of bioactivity and the dose-response relationships in several intractable cancers, which confirms and reveals the physiological mechanisms-of-action. These quantitative aspects of applied pharmacology are of paramount importance in establishing the clinical utility of a major new class of biological agents. Moreover, the progressive and adaptive trial designs helped to create and refine the clinical protocols for future medical praxis.

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 high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine.

To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com, or visit: www.epeiusbiotech.com.

Clinical Studies Validate Cancer Gene Delivery Platform: Landmark Publication Confirms Rexin-G Effectively Targets Metastatic Cancers

23 Jun 2009

Epeius Biotechnologies stuns the medical and scientific communities with a dramatic demonstration of single-agent efficacy with its lead product, Rexin-G, for metastatic cancer. The landmark article (accessible online as of June 16, 2009 in Molecular Therapy, the Official Journal of The American Society of Gene Therapy, documents the results of two related studies using Rexin-G, a tumor-targeted anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body, while sparing normal cells and healthy tissues and organs. Following the FDA's designation of Rexin-G as an Orphan Drug for the treatment of soft tissue sarcoma and osteosarcoma in 2008, the results of these two independent studies represent a major step toward gaining Accelerated Approval of Rexin-G for osteosarcoma in the United States.

"It took several years of painstaking safety studies, followed by gradual, progressive dose escalations, to the point where tumor control was consistently demonstrated, said Dr. Erlinda M. Gordon, Medical Director of Epeius Biotechnologies. Yet the progressive development strategy has finally paid off with real dividends: (1) By establishing the overall safety of the tumor-targeted gene delivery platform first and foremost, (2) By establishing critical pharmacological thresholds of bioactivity and dose-dependent efficacy for a new class of biological anti-cancer agents in otherwise intractable cancers, and (3) By validating the potential of Rexin-G to control metastatic cancer with single-agent efficacy, whereas other targeted therapies must be used in combination with one or more toxic agents in order to achieve even marginal results. The dividends for the cancer patient can now be measured in terms of overall survival, which is considered to be the gold standard in terms of evaluating efficacy.

About Epeius Biotechnologies

Rexin-G is commercially available for the treatment of all solid tumors in the Republic of the Philippines, and has "fast track status" as a treatment for pancreatic cancer in the United States. Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its high-performance gene delivery systems.

Sources: Epeius Biotech
Article URL: http://www.medicalnewstoday.com/articles
/154894.php

Clinical Remissions in Three Otherwise Intractable Cancers Signal the Progress of Targeted Genetic Medicine
Mon, 12 Oct 2009, 13:49:28 EDT

Tumor-targeted REXIN-G Quells Metastatic Osteosarcoma, Prostate Cancer, and Pancreas Cancer as Stand-alone Therapy.

SAN MARINO, Calif., Oct. 12 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced more stunning results of its pioneering clinical studies of Rexin-G®, the world's first and, so far only, tumor-targeted genetic medicine to be validated in the clinic. Administered as stand-alone therapy in late-stage cases of chemotherapy-resistant cancer, Rexin-G has once again accomplished what standard cancer treatments and even much-touted biologics have failed to do: that is, to bring forth the benefits of remission in otherwise intractable metastatic cancers. Three recent cases of Stage IV metastatic cancer, namely (i) osteosarcoma, (ii) prostate cancer, and (iii) pancreas cancer, demonstrated that Rexin-G treatments alone led to clinical remission of disease in each of these poor prognosis patients.

Even more remarkable, perhaps, are the profiles of the latter two patients, which signal the advent of Rexin-G as the vanguard of a new class of exceedingly precise, selective, and effective anti-cancer agents, and which typify a newfound societal acceptance and acknowledgement of the real-world promise and potential of this uniquely-targeted genetic medicine.

Remarkably, a Catholic priest, who was previously bedridden and in withering pain, suffering from end-stage prostate cancer that had spread to his bones, received successive courses of Rexin-G, during which time the bone pain was relieved, the PSA tumor markers fell, the bone tumors stopped growing, and even the previously inoperable primary tumor disappeared on follow-up CT scans. As the priest's bones began to heal and strengthen, he arose from his bed and is currently saying daily Mass and delivering lectures in the seminary. What is even more remarkable is that this revered man of the cloth was over ninety years old at the time of his treatment and remission.

This past week, the latest good news comes from the trenches of Stage IVb pancreas cancer, where a complete clinical remission was documented in a patient undergoing Rexin-G treatment as stand-alone therapy in an ongoing U.S. Phase I/II clinical trial.

According to Erlinda Maria Gordon, M.D., Medical Director of Epeius Biotech, "It is gratifying to learn that more and more eminent medical oncologists around the world are recommending Rexin-G as 'Best Care' for patients with refractory metastatic disease, and even more gratifying to show how truly effective Rexin-G at these doses can be in eradicating such difficult cancers."

Indeed, as the unprecedented single-agent efficacy of Rexin-G is incontrovertibly demonstrated in an increasing number of chemo-resistant cancers, the progressive steps of these intrepid pioneers may provide a rational basis of hope and expectation for many when standard therapy has failed. Rexin-G is approved for the treatment of all solid tumors in the Philippines, and has been granted both Orphan Drug Status for pancreas cancer, osteosarcoma and soft tissue sarcoma, and Fast Track Designation for pancreas cancer by the U.S. FDA.

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, please visit us at www.epeiusbiotech.com.

NEWS SOURCE: Epeius Biotechnologies Corporation

Send2Press® is the originating wire service for this story.

PRESS RELEASE PERMALINK: http://www.send2press.com/newswire/2...1012-002.shtml

October 14, 2009

October 14, 2009 PDF Version
Advanced U.S. Clinical Trial Confirms Single-Agent Efficacy of Rexin-G in Metastatic Pancreas Cancer: All Endpoints Achieved.
Epeius Biotechnologies Reports Dose-Dependent Efficacy and Survival Benefits.
San Marino, Calif. - October 14, 2009 - Epeius Biotechnologies (www.epeiusbiotech.com) confirms the first real breakthrough for pancreatic cancer seen in years; publishes a landmark report of tumor-targeted Rexin-G as stand-alone therapy in chemotherapy-resistant pancreatic cancer. Following Phase I studies at the Mayo Clinic, which affirmed the general safety of Rexin-G, advanced U.S. Phase I/II studies were undertaken, which included a Phase II efficacy component and examined progressive dose escalations of Rexin-G, while monitoring objective tumor responses in a comprehensive manner. Employing these higher doses of Rexin-G led to improved tumor responses, as assessed by all available measures (RECIST, Intl. PET and CHOI criteria) and nearly tripled the expected survival time, all in a dose-dependent manner. Moreover, this U.S. study serves to establish a critical pharmacological threshold of bioactivity, for this otherwise intractable disease, by demonstrating an increase in overall survival time (measured as % surviving 12 months) from virtually nil using low doses to more than 28% of the patients using high doses surviving beyond one year.
By meeting all primary and secondary study endpoints of safety and efficacy, Epeius Biotechnologies’ Rexin-G has succeeded in an area of clinical oncology where many promising biologics have simply failed to deliver. By achieving both progression-free survival and overall survival benefits in pancreas cancer, while avoiding untoward systemic or dose-limiting toxicities, Rexin-G has raised the bar for the entire biopharmaceutical industry, as it inaugurates the emerging field of precision-targeted genetic medicine. The outstanding results of this advanced U.S. clinical trial confirm the results of previous preclinical and clinical studies conducted in the Philippines (where Rexin-G is approved for all solid tumors), and demonstrate beyond contestation that Rexin-G, at these effective dose levels, exhibits profound anti-tumor activity when administered as a single therapeutic agent in otherwise intractable Stage IV pancreatic cancer. The success of these landmark studies is a tribute, not only to the clinical investigators who “held the course” and the “cause” of a better medicine as a high standard, but to the U.S. FDA who, by allowing across-the-board dose escalations in ongoing trials for sarcoma, breast, and pancreas cancer (once general safety was established), served to expedite the achievement of these effective doses, and thus these heartening results. The full article, authored by Dr. Sant P. Chawla et al., is now available online (Molecular Therapy, Oct 13, 2009; see Advance Online Publications: www.nature.com/mt/).

Epeius Biotechnologies Corporation Expands its Rexin-G Production Facilities in Southern California

Fri, 19 Feb 2010

Read more: http://www.earthtimes.org/articles/s...#ixzz0g02CUwc0

Rich66 · 11-05-2009, 01:41 AM

Teenager’s fight against cancer now being waged in Manila

Posted By John Campbell
Posted 24 days ago
By John Campbell Community Press
Wooler – Darren Vink’s two-year battle to overcome cancer now lies in the hands of a clinic in the Phillipines where he’s getting injections of a drug not yet approved in Canada.
Vink, 17, began receiving Rexin-G, a form of gene therapy that targets tumours, July 20 and the initial results have been encouraging. Two of the visible tumours, on his ribs and chest, shrank by about 20 per cent within a week of starting treatment, “which is incredible, best news we’ve heard,” said his father, John, last week.
Staff at the clinic are “amazed ... (by) the amount of progress that he’s made, he’s surpassed all their other records.”
Those who know Darren aren’t surprised. The teenager, who loves to tinker with farm engines, attend 4-H meetings and go paintballing with friends, has shown remarkable resilience since being diagnosed with osteosarcoma in his right femur in July 2007, He started chemotherapy immediately and had his knee replaced in October. The chemotherapy ended in April 2008 but four months later Darren began complaining of pain in his other knee. Tests confirmed the cancer was back, this time in his spine and lungs as well as his left knee. Since then he’s had two major surgeries on his spine and his other knee replaced.
Radiation and surgeries slowed progression of the disease but by spring of this year the staff medical oncologist at Mount Sinai Hospital in Toronto where Darren was being treated was telling the family, “We’ve given the best drugs we can for chemotherapy. Unfortunately, there’s nothing more we can do,” John said. “They never did say (Darren) has X amount of days to live ... We never asked nor did we really want to know.”
And Darren showed no signs he was about to let cancer get the better of him. He continued to live his life much as he had done before, doing the things that boys his age like to do, such as riding on a four-wheeler – but in his case using a long stick to shift gears.
Although is body is frail and the cancer has taken its toll, “Darren is still strong,” his father said. “How can we give up.”
Darren isn’t about to nor are his parents and three siblings, along with friends of the family and members of the community who have shown their support with numerous acts of kindness and donations of money.
It was Darren’s mother, Ilse, who read about Rexin-G on a cancer blog in June and got the ball rolling for her son to begin receiving treatment at the Epieus clinic in Manila. The gene therapy, which targets and destroys cancer cells, is still in clinical trials in the United States but is commercially available in the Phillippines.
“The scientific articles on Rexin-G, sponsored by the manufacturer, claim cessation of disease progression, and improved survival times,” said Dr. Kathy Wilkins, a Campbellford veterinarian and close friend of the family.
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The founder of the clinic, Dr. E.M. Gordon, “communicated extensively with the Vinks via e-mail to determine Darren’s eligibility to start Rexin-G,” Wilkins said. She “also put them in touch with the Lazarex Cancer Foundation.” Its mission is “To provide resources for cancer patients who’ve been told they have no other options but who are not yet done with their journey in life and refuse to give up now.”
The foundation “has been instrumental in getting Darren and Ilse to the Philippines,” Wilkins said, covering all their travel, accommodation and treatment costs – $40,000 – for the first month.
Darren, who is being given Rexin-G five times a week, is about to complete his first round of treatment and return home within days. He’ll rest for two weeks before heading back to Manila to begin a second round.
Four to five treatment cycles will be necessary and the surgical removal of the remaining tumour masses, if possible, could follow.
“It’s terrific that he’s seen such good response to the medication but they’re half-way across the world and they want to be home,” Wilkins said.
She is assisting the Vinks in applying to Health Canada’s Special Access Program to have Darren be treated with Rexin-G in Toronto by an oncologist at the Hospital for Sick Kids who’s a member of its New Agents and Innovative Therapies Group.
Wilkins has enlisted the help of Andrew McFadyen, a Trent Hills resident who went through the same process for his son Isaac, who suffers from an extremely rare disease caused by an enzyme deficiency.
His campaign to have the federal government approve use of medication that his son needed made headlines because the annual cost of his son’s medication is huge, in the hundreds of thousands, which the provincial government, as health-care provider, wasn’t prepared to assume initially. It did eventually as a result of intensive lobbying by McFadyen and his supporters.
McFadyen accompanied John Vink to a meeting this week with an oncologist at Sick Kids who “does seem receptive to the idea” of taking Darren on as a patient; it’s a commitment the federal program requires in order to allow use of a medication not yet approved in Canada. It’s also essential that provincial funding be secured to underwrite the cost of treatment.
McFadyen said Monday he has spoken to local MPP Lou Rinaldi to inform him of the family’s situation and to make him aware the Ontario government will be asked to help.
“I’m quite confident Lou, with his experience, will be passionate and work as diligently as he can on the file in order to advance it,” he said.
And he will continue “to advocate on behalf of the family at the federal level if it needs to go there,” added McFadyen.
“I’ll be here as a contact for them and a voice if they need one.”
He said the Vinks “have a whole slew of things going on” – dealing with a sick child, looking after three other children, running a farm that raises beef cattle – so moving the approval process forward as quickly as possible is critical, which he hopes to facilitate by drawing upon his own experience.
“There’s not a day that goes by that I don’t remember exactly where we were and how difficult that was.”
Darren and his mother are to meet with the oncologist next week.
John Vink said he and his family are thankful for the generosity the community has shown them. “I hate to think how things would be otherwise,” he said. The costs involved in making sure Darren is given the best medical care the country provides “would have been too much for us to do on our own,” he said. “Every day there’s somebody else (stepping forward). They’re praying for you or they’re helping out financially.” Or making meals – “the list goes on.”
Even though Canada’s health-care system overall has “been good,” John said,, “unfortunately, (it’s not) been quite good enough.”
Marion Greveling, a 4-H parent and friend of the family, is spearheading fundraising efforts on behalf of Darren. Anyone wishing to make a donation or assist in any way can call her at 613-475-2075.

Rich66 · 11-18-2009, 01:28 AM

Mol Ther. 2009 Oct 13. [Epub ahead of print]
Advanced Phase I/II Studies of Targeted Gene Delivery In Vivo: Intravenous Rexin-G for Gemcitabine-resistant Metastatic Pancreatic Cancer.

Chawla SP, Chua VS, Fernandez L, Quon D, Blackwelder WC, Gordon EM, Hall FL.
Sarcoma Oncology Center, Santa Monica, California, USA.
Rexin-G, a nonreplicative pathology-targeted retroviral vector bearing a cytocidal cyclin G1 construct, was tested in a phase I/II study for gemcitabine-resistant pancreatic cancer. The patients received escalating doses of Rexin-G intravenously from 1 x 10(11) colony-forming units (cfu) 2-3x a week (dose 0-1) to 2 x 10(11) cfu 3x a week (dose 2) for 4 weeks. Treatment was continued if there was less than or equal to grade 1 toxicity. No dose-limiting toxicity (DLT) was observed, and no vector DNA integration, replication-competent retrovirus (RCR), or vector-neutralizing antibodies were noted. In nine evaluable patients, 3/3 patients had stable disease (SD) at dose 0-1. At dose 2, 1/6 patients had a partial response (PR) and 5/6 patients had SD. Median progression-free survival (PFS) was 3 months at dose 0-1, and >7.65 months at dose 2. Median overall survival (OS) was 4.3 months at dose 0-1, and 9.2 months at dose 2. One-year survival was 0% at dose 0-1 compared to 28.6% at dose 2, suggesting a dose-response relationship between OS and Rexin-G dosage. Taken together, these data indicate that (i) Rexin-G is safe and well tolerated, and (ii) Rexin-G may help control tumor growth, and may possibly prolong survival in gemcitabine-resistant pancreatic cancer, thus, earning US Food and Drug Administration's (FDA) fast-track designation as second-line treatment for pancreatic cancer.

PMID: 19826403 [PubMed - as supplied by publisher]

Scientists Rediscover Gene Target for Cancer Therapy - Rexin-G Receives High-tech Validation as Strategic Anti-cancer Agent
Tue, 15 Dec 2009, 12:10:59 EST

SAN MARINO, Calif., Dec. 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, gained international validation of the cutting-edge science behind its lead oncology product, Rexin-G®, when scientists around the world rediscovered the Cyclin G1 gene to be a major locus of cancer pathogenesis and disease progression, and thus a prime target for anti-cancer therapies. Recently, scientists at the NIH National Cancer Institute investigating the role of microRNAs (miRNAs) in tumor development and their utility to serve as biomarkers for cancer diagnosis and prognosis identified one particular species of miRNA (designated miR-122) that was linked to both the development and the aggressiveness of liver cancer (Coulouran et al., Oncogene, 2009).

While microRNAs are natural negative regulators of protein coding genes, miR-122 is characteristically suppressed in hepatocelluar carcinomas, and conversely its "therapeutic" re-expression was found to reverse the tumorigenic properties of the cancer cells in terms of growth, replication potential, invasion, and tumor formation (Bai et al., J Biol Chem, 2009). Scientists working in Italy and the USA, using miRNA libraries as probes in high throughput microarray assays to screen for sequences that are dysregulated in human cancers, independently implicated miR-122 in the pathogenesis of liver cancer and further demonstrated that the tumor suppressive action of this particular mRNA is manifested through the inhibition of the Cyclin G1 gene (Gramantieri et al., Cancer Res, 2009).

The finding that the natural suppression of the Cyclin G1 gene is lost in cancer cells is not at all surprising to scientists at Epeius Biotechnologies, who first identified the human Cyclin G1 gene as a proto-oncogene in 1994, demonstrated its therapeutic potential in a comprehensive series of landmark studies (1995-2005), and designed the sophisticated dominant-negative "knockout" construct embodied in the powerful anti-cancer agent Rexin-G (see Gordon and Hall, Intl. J. Oncology, 2009).

According to Dr. Frederick L. Hall, President and CEO of Epeius Biotech, "It is gratifying to find that functional genomics and high-throughput screening have finally served to direct basic research away from simplistic antibodies and superficial blockades of receptor-mediated pathways to the crux of the matter and the final common pathways of cell cycle control. Moreover, it is always reassuring when a basic mechanistic understanding of the logic and executive enzymology of a biochemical pathway serves to trump the rolling of dice."

The finding that miR-122 targets Cyclin G1 gene expression confirms that Rexin-G may indeed be restoring a natural tumor suppressor function that is lost in the development and progression of many types of cancer; while the pathotropic (or disease-seeking) properties of Rexin-G function to deliver this agreeably rational and strategic anti-cancer agent precisely where it is needed most.

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 leading oncology products and its tumor-targeted gene delivery systems. Rexin-G®, a tumor-targeted anti-cancer agent that is approved for use against all solid tumors by the Philippine FDA, and has recently received three Orphan Drug priorities and Fast Track designation by the U.S. FDA.

Please visit us at www.epeiusbiotech.com.

Rich66 · 12-16-2009, 11:42 AM

updated................................

Faith in Him · 12-17-2009, 08:43 PM

Fast track for the US FDA. Does this mean the FDA will approve this soon?

Rich66 · 12-17-2009, 09:05 PM

"The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well."

Might be available "off-label" once approved for pancreas cancer. Almost unheard of remission in pancreatic cancer as single agent with low toxicity. Faster.