Cancer patient beating the odds (Rexin-G)

[Rich66]

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

[Believe51]

Thanks Pal, I will be passing this on to Rose, she will be so happy. I was kind of sad today and this made me smile through it all.>>Believe51

[hutchibk]

Danke schön, Rich. I need to keep this in my back pocket.

[Lori R]

Rich,
Thank you for posting. The challenges expressed lately by many on the board have left me sad and feeling like this darn disease is getting the best of us. This is a reminder that we WILL overcome!!!

Lori

[Rich66]

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,

[Faith in Him]

Thank you Rich, for bringing this to our attention.

[Rich66]

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.

[Rich66]

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

[Believe51]

LoriR, I wish you could see my option list that I have titled, 'HOPE'. Rexin-G is there along with many many years of scientific research and many many hours of pulling that research to the surface. Let us hold hands knowing that we shall overcome. Where there is life, there is hope. Please take this gynormous cyberhug and know we never walk alone!!>>Believe51

[Lori R]

Dear Marie,
Thank you for the reminder as to the variety of treatments in development. Rexin - G sure sounds like an option that will be available reasonably soon.

But...the most uplifting statement you made is that we don't have to make this journey alone. Thank you for constantly being there to remind me of that.

Cyber - Hugs back at ya....Lori

[fullofbeans]

Thank you for your always very informative articles and great finds.

[Believe51]

Yes, Rich is the 'Man'!!>>Believe51

[Rich66]

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.
Advertisement





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]

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