Tarvacin(TM) Effective in Imaging Prostate Cancer, Peregrine Pharmaceutical
Main Category: Prostate / Prostate CancerArticle Date: 20 Apr 2005 - 20:00 PDT
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Peregrine Pharmaceuticals, Inc reported that data was presented at the American Association for Cancer Research (AACR) Annual Meeting in Anaheim, California showing the potential use of Tarvacin(TM), its lead Anti-Phospholipid Therapy agent, for imaging solid tumors. The presentation talk was titled "Tumor Imaging With The Vascular Targeting Antibody Tarvacin(TM) Labeled with Arsenic Isotopes". Data presented showed that Tarvacin(TM) could be used to deliver a radioactive arsenic compound to prostate cancer blood vessels for tumor imaging. An earlier presentation at the AACR Annual Meeting had shown the potential of Tarvacin(TM) for the treatment of prostate cancer. Peregrine expects to begin patient enrollment in a Tarvacin(TM) phase I clinical trial for the treatment of cancer within the next 30 days.
"These imaging data indicate another potential utility for Tarvacin(TM) and other agents that fall under our Anti-Phospholipid Therapy technology platform," said Steven King, president and CEO of Peregrine Pharmaceuticals. "We will continue to explore additional ways to fully utilize this technology platform for the treatment and therapy of cancer and other diseases. In addition to its anti-cancer activity, the company recently announced data showing Tarvacin's impressive anti-viral activity and the company has been evaluating the compound for activity in treating ocular disease."
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a broad portfolio of products under development directed towards the treatment of cancer, viruses and other diseases. The company plans to initiate patient enrollment in two separate clinical trials for the treatment of all solid tumors using Tarvacin(TM) (under its Anti-Phospholipid Therapy platform) and for the treatment of brain cancer using Cotara(R) (under its Tumor Necrosis Therapy platform). Our agents in development for oncology applications fall under several different proprietary platforms, including Anti-Phospholipid Therapy, Vascular Targeting Agents (VTAs), Tumor Necrosis Therapy (TNT), Anti-Angiogenesis, and Vasopermeation Enhancement Agents (VEAs). Our viral therapy approach is based on the fact that enveloped viruses and virally infected cells have phospholipids exposed on their surface and thus can be targeted using our Anti-Phospholipid Therapy agents.
Peregrine Pharmaceuticals also has in-house expertise to develop and manufacture antibodies and recombinant proteins through its wholly-owned subsidiary, Avid Bioservices, Inc., (http://www.avidbio.com). Avid is engaged in providing contract manufacturing services and development of biologics for biopharmaceutical and biotechnology companies, including Peregrine. Copies of Peregrine Pharmaceuticals press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.peregrineinc.com
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements, which include statements with respect to the potential therapeutic benefits, both alone and in combination with other treatment methodologies, and successful development of drug candidates, involve risks and uncertainties including, but not limited to, the risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchanges Commission, including its Annual Report on Form 10-K for the year ended April 30, 2004, and its quarterly report on Form 10-Q for the quarter ended January 31, 2005. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing pre-clinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, pre-clinical studies or clinical trials; our ability to obtain additional financing to support our operations and the development of our products; our ability to obtain regulatory approval for our technologies; the timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. The Company cautions investors not to place undue reliance on the forward looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in this press release.
Investor Inquiries
Hawk Associates, Inc.
Frank Hawkins and Ken AuYeung
(800) 987-8256
info@hawkassociates.com
Media Inquiries
Rachel Martin
Edelman
323) 202-1031/(323) 893-9047
Rachel.Martin@edelman.com
Peregrine Pharmaceuticals, Inc. http://www.peregrineinc.com
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Dr. Thorpe’s APT Attack CANCER & VIRUSES
posted by Colonel J Gaddy on 24 May 2005 at 10:49 amThis is an update on the progress of Dr. Philip Thorpe’s “Anti-Phospholipid Therapy” (APT) for the treatment of ALL SOLID CANCERS and ALL ENVELOPED VIRUSES (HIV/AIDS, Hepatitis, Influenza, Pneumonia, Herpes, Avian Flu, Pox Viruses, SARS, Ebola…). “SAFE CONTROL”, not “CURE” is the hopefully attainable goal of APT, as you will see below.
ATP ANTI-CANCER – LAYMAN DESCRIPTION:
Phospholipids PS & PE (the building blocks of ALL cell membranes) stay on the inside of normal, healthy cells. However, in all solid tumor blood vessels, they “flip inside out”, becoming exposed, resulting in what Thorpe calls, “the cleanest tumor vessel marker of which we are aware”. Thorpe isolated Anti-PS antibodies, like 3G4/Tarvacin, that target these exposed lipids and induce an influx of white cells to attack the tumor. Primate tests of 3G4 as a monotherapy showed significant tumor inhibition and reduction in metastases; even more so when combined with chemo’s like Docetaxel or Gemcitabine. Most importantly, per Thorpe, “In mice and monkey tests, we've never seen any sign of toxicity; about 14 species treated with the therapeutic dose - and that's thousands of mice and monkeys. And that’s even if you increase the dose to 10x the therapeutic dose.”
ATP ANTI-VIRAL – LAYMAN DESCRIPTION:
Partially by accident, partially by hunch, Thorpe discovered that when enveloped viruses (HIV, Hepatitis, Influenza, etc) exit from their invaded host cells, they become coated with PS, and thus are targetable by the same Anti-PS antibodies initially developed to treat cancer. 3G4 attacks viruses in 3 ways:
1) It binds to PS on the viral membrane, which stops the virus from penetrating the outer membrane of the cell.
2) It binds to PS as the virus travels to externalize, and stops the process of viral escape.
3) When the virus is out of the cell, and circulating around in the blood and in tissues, it causes that virus to be captured.
In 3G4 animal tests sponsored by the NIH/NIAID, “dramatic survival benefits” were obtained against lethal doses of Lassa Fever. Moreover, 3G4 treated guinea pigs who survived the Lassa infection became immune to subsequent infections with the same viral strain. Also, since 3G4 attacks viruses indirectly (“via host physiology, not the viral genome”), viral resistance is much more difficult to achieve (big issue for AIDS).
Def’s:
“Phospholipids” = the basic building blocks of cell membranes, chain-like molecules having a hydrophilic (water-attracted) head at one end and a hydrophobic (water-repelled) tail at the other; subtypes: aminophospholipids such as phosphatidylserine (PS) and phosphatidylethanolamine (PE), and choline-containing phospho¬lipids.
“APT” = “Anti-Phospholipid Therapy” (Anti-PS, Anti-PE etc) - a class of targeted therapeutics discovered & patented by Dr. Phil Thorpe
“Anti-PS” = an immunoconjugate antibody that targets PS
“Anti-PE” = an immunoconjugate antibody that targets PE
“3G4” = one of several murine Anti-PS mabs (others: 1B12, 3B10, 9D2)
“Tarvacin” = chimeric 3G4, entering Phase1 for ‘All Solid Tumors’ and soon for Hep-C
MAY2005 ARTICLE PROVIDING A GOOD OVERVIEW OF 3G4/TARVACIN:
‘Bioprocessing Journal’ - May 2005, “TARVACIN HEADS TO THE CLINIC”
by Gordon Kelley – Gkelley@wilbio.com
http://www.bioprocessingjournal.com/pdf/Tracks_Trends.pdf
The underlying principle in antibody-based therapy is the exquisite ability of monoclonal antibodies (MAbs) to bind specific molecules, or even specific epitopes on a specific molecule. In cancer therapy, this allows "molecular targeting" of certain tumors that express or overexpress a particular cell surface protein, while leaving normal tissues off an antibody's radar screen. The principle is sound and is reflected in the regulatory approvals of MAbs such as Herceptin, which targets HER-2 to treat breast cancer; Avastin, which targets vascular endothelial growth factor (VEGF) to treat metastatic colorectal cancer and other VEGF-overexpressing tumors; and Erbitux, which targets the epidermal growth factor receptor (EGFR) to treat colorectal cancer. But the antigenic grail - which Peregrine Pharmaceuticals believes it may have found in the form of phosphatidylserine [PS] - is a marker that is expressed on blood vessels in all solid tumors and not on blood vessels in normal tissues. Peregrine recently received the go-ahead from FDA for a Phase I study of Tarvacin an antibody to PS, after the company showed stunning results from preclinical animal studies.
Antibodies can do a great job at targeting and destroying cells, but they're not much use if they can't access the malignant cells locked in tumors. To get around the difficulty of penetrating solid tumors with macromolecules, MAbs such as Avastin, that slow tumor growth by blocking angiogenesis, have been developed. Tarvacin, however, represents a novel means to kill tumors: instead of using an antiangiogenic mode of action to shut down sprouting blood vessels, it targets and destroys both existing and newly developing tumor vasculature. Its target, PS, is an anionic phospholipid that is an integral part of all eukaryotic cells' outer membrane. In normal cells, PS is solely on the internal leaflet of the plasma membrane, oriented toward the cytoplasm. However, in cells experiencing oxidative stress, the normal membrane homeostasis is disrupted and PS is translocated to the cell surface and abundantly exposed. Because this includes endothelial cells that line blood vessels, PS is therefore a specific, stable marker of tumor vasculature and a prime target for antibody therapy. According to Peregrine, anionic phospholipids are absent from the outside of vascular endothelial cells in all normal tissues.
The idea behind Tarvacin is that by blanketing PS-expressing vascular endothelial cells with antibodies, antibody-dependent cellular cytoxicity (ADCC) is initiated: phagocytes are recruited in vast numbers to the tumor site and begin to dismantle the tumor vasculature. "What blocks the blood vessels is the arrival of white blood cells which either directly kill the vascular endothelium of the tumors, or they physically block them up," says Dr. Phil Thorpe, a professor of pharmacology at the Univ. of Texas SW Medical Center who invented anti-phospholipid [Anti-PS] targeting. "Sometimes so many come in that you can't see how they function as blood vessels." The beauty of this macrophage-mediated synergistic approach is that it should specifically target and starve any solid tumor fed by the blood stream, including emerging metastases
IMAGES OF TARVACIN: Tumor vessel destruction by Tarvacin. Tarvacin (3G4) homes specifically to phosphatidylserine [PS] on blood vessels in tumors after injection into mice (LEFT). It summons white cells to bind to the tumor vessels (MIDDLE). The vessels are destroyed and necrosis (N) develops in the interior of the tumor. A viable (V) rim of tumor cells survives that can be killed by chemotherapy. From Ran, He et al., Clinical Cancer Research (2005);11,1551-1562.
TARVACIN CLINICAL TRIALS
The recently approved [1-27-05] Phase I trial of Tarvacin will enroll up to 28 patients with advanced solid tumors of any kind that no longer respond to standard treatments. Although the clinical study is ostensibly just to determine safety, pharmacokinetics, dose-limiting toxicities, and maximum effective dose of IV-administered Tarvacin, the company will be paying close attention to any therapeutic effects. Each patient's participation in the trial will take approx. 10 weeks, but depending on efficacy, patients may be offered continuous therapy on an extension study. Peregrine expects the trial to take about a year.
TARVACIN - WITH CHEMO AND WITHOUT
In October 2004, Dr. Thorpe presented "An Understanding of Tarvacin" at Peregrine's shareholder meeting. He showed the results of animal studies done with Tarvacin's closely related murine parent antibody, 3G4. (Tarvacin is a chimera of 3G4's variable regions fused to a human IgG 1 constant region. It is indistinguishable from 3G4 in terms of its ability to localize to tumor vasculature.) In mice and rats, treatment with 3G4 suppressed tumor growth by 60 to 90% in breast tumors, Hodgkin's tumors, and sarcomas. Describing a slide of a highly vascularized tumor, he said, "You'll see, most remarkably, that it's chockablock full with macrophages. Every one of those [green dots] is a macrophage and there are so many of them that they're beginning to outnumber the tumor cells." He also showed 3G4's effectiveness at treating one of the primary problems with cancer: metastases. Peregrine modeled metastases of breast cancer, in which the tumor homes to the lungs and forms colonies. "Here's what happens if you treat with 3G4," he said. "It greatly reduces colonization, although not completely. You can see there's a big reduction in lung tumor colony formation."
Dr. Thorpe went on to demonstrate that the antibody is even more effective (in animals) when combined with standard oncology treatments. Describing the results of combining 3G4 with the chemotherapeutic Docetaxel, he said, "Practically none of the lungs have any sign of disease. It's quite impressive." Specifically, in results presented at last year's AACR meeting, Peregrine showed that 3G4 plus Docetaxel reduced breast cancer tumors by 93%. The company had similar results when it tested a murine model of pancreatic cancer: A combination of Gemcitabine [Lilly’s Gemzar] and 3G4 dropped the number of liver metastases by 90%, and only 40% of the animals developed liver metastases at all. "That's exactly what we hope to do with humans." enthused Dr. Thorpe.
Tarvacin shows its best activity when combined with conventional chemotherapeutic drugs or radioactivity, according to Peregrine CEO Steve King. "The reason that works is because chemotherapeutic drugs or radiotherapy increases exposure of anionic phospholipids on the tumor blood vessels," says King. "In effect, what it does is expand the target for attack by Tarvacin," he adds. In addition, Tarvacin does not appear to enhance the toxicity of chemotherapy or radio-therapy. Tarvacin alone is relatively non-toxic. In a cynomolgus monkey safety study intended to gauge toxicity, King says that even at 10 times the anticipated maximum therapeutic dose (1 mg/kg) given repeatedly, there were no signs of adverse effects.
MANUFACTURING TARVACIN (AVID BIOSERVICES)
Tarvacin is manufactured by Peregrine's subsidiary, Avid Bioservices, using a CHO cell line grown in suspension. Rich Richieri, Avid's VP of mfg., says that all materials used in the process are animal-free, and that the purification uses standard, generic protein A-based chromatography followed by ion-exchange polishing steps. "One of the things we wanted to do at Avid was create a process that is scalable, so that if Peregrine were to scale up at Avid, or go with a corporate partner or another facility where they had 5,000-liter tanks, this process could be easily adapted to those systems," he explains. Using well-known processes and off-the-shelf materials should also help FDA's "comfort level."
TARVACIN - ANTI-VIRAL
As if the company wasn't enthusiastic enough about Tarvacin, the antibody may also prove to be a novel treatment for diseases caused by enveloped viruses. Most major viruses are enveloped, including influenza, vaccinia, Lassa fever virus, and cytomegalovirus. When these viruses enter cells, their outer membrane envelope is stripped and the viral capsid translocates to the cell nucleus where it hijacks the cellular machinery in order to pump out hundreds of copies of itself. Upon egress from the cell, budding viruses use the outer lipid membrane to make their envelope. Because a virus has no preference for which parts of the cell membrane it uses, enveloped viruses end up covered in aminophospholipids and anionic phospholipids, particularly phosphatidylserine [PS].
This means that Tarvacin should be able to dock on virus capsules as easily as it localizes to tumor vasculature. In a rodent test of advanced Lassa fever, all the control animals died and half the Tarvacin-treated animals rejected the virus and lived normally. With early results like this, although Peregrine is pursuing anti-tumor therapy as its first avenue for commercialization, the company is understandably enthusiastic about the antibody's potential as an anti-viral therapy. The next few years should be heady times for Peregrine Pharmaceuticals.
*end of BioProcessing article*
SHORT TARVACIN/3G4 MOA SUMMARY IN UT-SW 5-15-05 ARTICLE:
http://www.utsouthwestern.edu/utsw/cda/dept37389/files/223516.html
“Antibody Combined With Cancer Drug Shows Promise Against Breast Tumors”
DALLAS, May 15 2005: “…VTAs like 3G4 target tumor vessels by selectively binding to a certain component in the membranes of endothelial cells that line tumor blood vessels. This component, called an anionic phospholipid, faces the interior of cells in normal blood vessels. In tumor blood vessels, however, changes in the tumor environment cause the phospholipid to flip inside out and be positioned on the external surface. VTAs then can bind to this exposed phospholipid, causing the body's white cells to attack and destroy the vessels feeding the tumor. By targeting receptors unique to tumor vessels, vascular targeting agents kill tumors without causing damage to surrounding healthy tissue. They also reduce the risk of side effects by operating at lower doses than traditional cancer therapies because they are effective without needing to penetrate the innermost layer of a tumor. And, while drug resistance caused by the instability and mutability of cancer cells is a significant problem with conventional therapies that target tumor cells, cells targeted by VTAs do not mutate to become drug resistant, Dr. Thorpe said. Tarvacin itself has shown promise in mice against cancers in the fibrous tissues, brain cancers and Hodgkin's disease...”
= = = = = = = = = = = OPINION / COMMENTARY:
Thorpe 10-25-04 on 3G4 ANTI-CANCER MOA:
http://tinyurl.com/dou8t & http://tinyurl.com/8b6kr
“If you look at the 3G4 slide, you'll see, most remarkably, that it's absolutely chock full with macrophages. There are so many of them that they're beginning to outnumber the tumor cells. So you can see the reaction that's being mounted against the tumor”.
Thorpe 10-25-04 on 3G4 REDUCTION of METASTASES:
http://tinyurl.com/dou8t & http://tinyurl.com/8b6kr
“Pancreatic cancer is a killer. Everyone who gets pancreatic cancer dies; you die not of pancreatic cancer but of spread to the liver primarily, and regrowth in the liver that we can't control. So this experiment is about pancreatic tumors spreading to the livers of the mice. We're trying to stop that by treating the mice with 3G4, or the best drug out there, Gemcitabine [Gemzar] or a combination of the two, in red. And you see that combination has dropped the number of metastases in the liver by, oh, that looks like more than 90% to me, in fact only 40% of the animals even had liver metastases, and it and saved them from death. And that's exactly what we hope to do with humans.”
Tarvacin/3G4 presented at AACR 4-2005:
http://tinyurl.com/a7zy4 & http://tinyurl.com/8oa5p
“3G4 + Radiation reduces lung cancer tumor growth by 95%. 3G4 + Gemcitabine decreased primary tumor growth by 60% and essentially stopped metastasis to liver and lymph nodes. Data is significant as it about to begin dosing trials of Tarvacin that allows for patients presenting with any solid tumor type.”
THORPE IN 10-25-04 “UNDERSTANDING TARVACIN” PRESENTATION:
http://tinyurl.com/dou8t & http://tinyurl.com/8b6kr
“Here, rodents were infected with Lassa Fever virus, a very lethal virus.. of the animals were getting Tarvacin, half the animals rejected the virus and went on to live normally. That's an extraordinary result, I don't know of any other antiviral agent that is known to protect against Lassa Fever. And we've also shown similar results in cytomegalovirus.”
Thorpe on TARVACIN ANTI-VIRAL PRE-CLINICALS at AAI Conf. 4-2005:
http://tinyurl.com/dn32v & http://tinyurl.com/bgg5o
“Surviving animals (50%) did not show any signs of viral infection several months after treatment with Tarvacin and were considered to have been disease free; they developed long-term immunity to further infection with the Pichinde virus. ...Since Tarvacin targets a basic, universal property of enveloped viruses that is host-derived and independent of the viral genome, it may be effective against a broad spectrum of enveloped viruses. This target may also be difficult for viruses to overcome via resistance mechanisms."
THORPE, ON 3G4’S ANTI-VIRAL POWERS 4-2005:
“The pre-clinical data demonstrate that Tarvacin/3G4 and related Anti-Phospholipid Therapy agents have anti-viral therapy which, if proven out in the clinic, has far reaching implications for the treatment of infectious disease… what is particularly exciting about these initial findings is that the recognition of viral particles by Tarvacin (3G4) is dependent on a structural component believed to be universal to all enveloped viruses, giving it the potential to be a broad-spectrum treatment. It is also a property that is determined by host physiology, not the viral genome, making viral resistance much more difficult to achieve.”
“To date, pre-clinical studies using 3G4/Tarvacin and other APT antibodies for treatment of viral disease have yielded extremely promising results. Based on the strength of this data and the pre-clinical safety evaluations of Tarvacin conducted in support of the upcoming cancer therapy clinical trial, we are looking to initiate clinical trials for treating viral diseases using Tarvacin in the near future…An interesting hypothesis still to be tested is whether treatment of one virus with APT agents confers protection against infection by other enveloped viruses.”
DR. MICHAEL SMITH, CHIEF of INFECTIOUS DIS., ST. MICHAEL'S MedCtr:
http://tinyurl.com/9qwen
"I look forward to working with Dr. Thorpe on these novel anti-viral agents; this approach represents an entirely new way of combating infectious diseases. Instead of targeting viral proteins, Thorpe’s product attacks altered, endogenous phospholipids. Therefore, drug resistance cannot develop." (2-8-05)
PAUL LYTLE ON ANTI-VIRAL at WALL ST. REPORTER SUMMIT 4-2005:
http://tinyurl.com/d4s9z
"We have talked to our SRB about Tarvacin Anti-Viral, including Drs. Preston Marx & Steven Smith, and when they saw the data they basically said "You don't need to treat any more animals, you need to get this into the clinic as soon as possible." And that's what we're doing. So stay tuned for future results regarding Tarvacin’s anti-viral potential."
THORPE 10-25-04 on 3G4 SAFETY:
http://tinyurl.com/dou8t & http://tinyurl.com/8b6kr
“In mice and monkey tests, we've never seen any sign of toxicity; about 14 species treated with the therapeutic dose - and that's thousands of mice and monkeys. And even if you increase the dose to 10x the therapeutic dose. If you go above that, you would see signs of prolongation of coagulation, and there are no significant changes in blood cell count, as would typically be the case with traditional antigens… So the conclusions with Tarvacin are that it has a unique mechanism of action, there's nothing else like it out there; it homes specifically to tumor blood vessels and induces white blood cells to attack the tumor. And, as we looked, it enhances the anti-tumor activity of chemotherapy drugs, several drugs, I've not shown you all of those, and also radiation. And it causes no toxicity in monkeys, rodents or atheroslerotic rabbits treated with the calculated therapeutic dose”.
FROM THORPE’S APT PATENT #20040161429 (pub USPO 8-19-04):
http://tinyurl.com/6pdny
[0909] “…the invention is not limited to the treatment of enveloped viruses alone, nor to any particular virus, which is an important advantage.”
[1302] “the 3G4 antibody has enormous potential as a broad spectrum anti-viral agent.”
[1303] “The 3G4 antibody thus possesses the combined properties of an anti-angiogenic, anti-tumor vascular and anti-viral agent. The inhibitory activities of 3G4 on cell division, angiogenesis, tumor growth and viral infectivity, taken together with lack of apparent toxicity, show broad therapeutic indications for this antibody, including in the treatment of angiogenic disorders, cancer, diabetes and viral infections.”
[0196] “the anti-viral methods and uses of the invention are suitable for treating all viruses... as exemplified by treating CMV, RSV, arenavirus and HIV infections, and the diseases hepatitis, influenza, pneumonia, Lassa fever and AIDS.”
[1298] “The 3G4 antibody has also been administered to monkeys in safety studies and no side effects have been observed.”
Virologist Dr. Michael Smith on Tarvacin Anti-Viral 2-2005:
http://tinyurl.com/9qwen
“I look forward to working with Dr. Thorpe on these novel anti-viral agents. This approach represents an entirely new way of combating infectious diseases. Instead of targeting viral proteins, Thorpe’s product attacks altered, endogenous phospholipids. Therefore, drug resistance cannot develop.”
"T H E R E F O R E,
D R U G
R E S I S T A N C E
C A N N O T
D E V E L O P."
NOTE: Dr. Smith is Chief of Infectious Diseases at St. Michael's Medical Center, Medical Dir. of the Peter Ho Memorial Clinic, the largest HIV clinic in NJ, and the Program Dir. of Infectious Diseases Fellowship at Seton Hall Univ.
Dr. John Minna on Thorpe’s VTA Discoveries (1998):
http://tinyurl.com/dzwmj
"I think Dr. Thorpe's [VTA] technology, if it works, eventually could apply to maybe 90% of all cancers and certainly to 80-90% of the cancers that kill people. I'm very excited about it. Of all the things that come through the pipeline, this is one of the most interesting things I've seen in my career. As I told Phil, it is my goal to be standing next to him at the bedside when we give the first dose of this to the first patient here at UT-SW. That will be an exciting time."
NOTE: Dr. Minna is Director of the UT-SW Jake L. Hamon Center for Therapeutic Oncology Research, and holds the Max L. Thomas Distinguished Chair in Molecular Pulmonary Oncology and the Lisa K. Simmons Distinguished Chair in Comprehensive Oncology.
Dr. Alfred Gilman on Thorpe’s VTA Discoveries (1998):
http://tinyurl.com/dzwmj
”The whole idea is predicated on an extraordinarily logical concept. The logic of Phil's theory is overwhelming and compelling. There are all sorts of problems associated with attacking malignant cells, such as their becoming resistant to treatments because they're growing and moving and doing all sorts of things that allow them to get away from you. The vascular endothelium isn't doing that; if you can target it successfully, you wipe out relatively small areas, and the blood will clot and kill off enormous numbers of tumor cells because you are cutting off their blood supply."
NOTE: Dr. Gilman is a Nobel laureate and holder of the Raymond Willie and Ellen Willie Distinguished Chair in Molecular Neuropharmacology, and chairs the Dept. of Pharmacology at UT-SW.
Dr. Judah Folkman on Thorpe’s VTA Discoveries:
http://tinyurl.com/co5vx & http://tinyurl.com/9nb2r
“This [Thorpe’s VTAs] is very promising and very elegant work... The whole goal is really two-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and antivascular therapy will play a major role."
NOTE: Dr. Folkman is Professor of Cell Biology at Harvard Medical School and is currently Dir. of the Vascular Biology Program at Children's Hosp. Boston. He is the author of 389 original peer-reviewed papers and 106 book chapters and monographs. He also holds honorary degrees from 15 universities and is the recipient of numerous national and international awards.
LLOYD KELLAND on MOA of THORPE’S ANTI-PS/3G4 (1-2005):
“Phosphatidylserine (PS) is an anionic phospholipid. Its main function is the formation of cellular membranes. In normal cells, anionic phospholipids are on the inside of the cellular membrane. It is now known that exposure of anionic phospholipids on the cell surface occurs during apoptosis (normal cells death), necrosis, cell injury, cell activation and malignant transformation into tumor cells. Studies in Dr. Thorpe's lab, which led to US Patents 6406693/6312694, also showed that factors in the tumor microenvironment cause a breakdown of asymmetry and exposure of anionic phospholipids on the cell surface of the blood vessels within malignant tumors.”
From: “Targeting Established Tumor Vasculature: A Novel Approach to Cancer Treatment”, by Lloyd R. Kelland, St Georges Hospital Med. School, Current Cancer Therapy Reviews, 2005, pg.1-9
http://www.bentham-direct.org/ben18/cctr1-1/kelland.pdf
VERTEX’s VX-950 VS. 3G4/TARVACIN - DOSAGE COMPARISON:
In May2005, Vertex published encouraging results of a Phase1 trial of their Hepatitis C virus inhibitor VX-950. Dosage: 750 mg x 3 times a day x 14 days = 31,500 mg. By contrast, Thorpe is planning 1-2 injections of 1-5 mg of TARVACIN for effective, safe anti-viral treatment against All Enveloped Viruses.
HISTORY – Tarvacin ANTI-VIRAL (AV):
8-2003 Thorpe files patent #20040161429 for APT’s as enveloped virus treatment
8-2003 Thorpe receives $1.68mm NIH/NIAID Grant to study 3G4 against Lassa Fever
10-2004 Thorpe 1st public talk on AV: “extraordinary preclinicals vs. Lassa Fever”
2-2005 Virologists Stephen Smith & Preston Marx join Thorpe’s SRB
2-2005 Dr. Smith says, "this approach represents an entirely new way of combating infectious diseases. Instead of targeting viral proteins, 3G4 attacks altered, endogenous phospholipids. Therefore, drug resistance cannot develop."
4-2005 3G4 animal data presented at AAI Conference, “Significant ANTI-VIRAL Activity”
4-2005 NIH/NIAID to test 3G4 on “Broad Spectrum of Enveloped Viruses"
5-2005 IND filed for Tarvacin to treat chronic Hepatitis C
HISTORY – Tarvacin ANTI-CANCER:
7-2003 Thorpe files patent #20040170620 for APT’s as solid cancer treatment
9-2004 IND filed for Tarvacin as treatment against ‘All Solid Tumor Types’
1-2005 FDA approves IND for Tarvacin against ‘All Solid Tumor Types’
3-2005 3G4 pre-clinicals pub. AACR article: "3G4 as a monotherapy inhibits tumor
growth by up to 90% in multiple tumor models.."
To see all 32 U.S. Patents GRANTED thus far to Phil Thorpe:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=thorpe+philip&FIELD1=INZZ&co1=AND&TERM2=&FIELD2=&d=ptxt
To see all 27 Patents PUBLISHED by Phil Thorpe, but not yet GRANTED:
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=thorpe+philip&FIELD1=IN&co1=AND&TERM2=&FIELD2=&d=PG01
PUBMED search on “THORPE PE” yields 114 published articles:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed
When virologists Dr. Preston Marx (Chair & Core Scientist of the Div. of Microbiology and Immunology at Tulane National Primate Research Center) and Dr. Stephen Smith (Chief of Infectious Diseases at St. Michael's Medical Center, Medical Dir. of the Peter Ho Memorial Clinic, the largest HIV clinic in New Jersey) joined Thorpe’s SRB in Feb2005, momentum for the inevitable 3G4 attack on HIV/AIDS was raised.
NIH ANTI-VIRAL MOMENTUM: An 8-2003 $1.68mm NIH/NIAID Grant to Thorpe/UT-SW to study APTs against Lassa Fever, and the 4-2005 expanded NIAID collaboration whereby:
“NIAID's testing laboratories will screen Thorpe’s Anti-Phospholipid Therapy (APT) agents, including Tarvacin, for activity against a broad spectrum of enveloped viral pathogens of health and bioterrorism concern. Virus types to be screened as part of the collaboration potentially include Herpes viruses, respiratory viruses, pox viruses, Hepatitis B/C, Papillomavirus and viruses of biodefense concern including Pichinde, Yellow Fever, West Nile and Dengue.”
http://crisp.cit.nih.gov/crisp/CRISP_LIB.getdoc?textkey=6855134&p_grant_num=5U01AI056412-03&p_query=&ticket=13834189&p_keywords=
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=691387
= = = = = = = = = = = = = = = =
More on Dr. Thorpe’s Background and his VTA / APT discoveries:
Dr. Thorpe’s Bio Sketch at UT-SW:
http://www.utsouthwestern.edu/findfac/research/0,2357,17308,00.html
Dr. Philip Thorpe
UT Southwest Medical Center, Dallas
Phone: 214-648-1268 philip.thorpe@utsouthwestern.edu
“Attacking The Killer Chameleon Cancer”, by S.Steeves, SW Medicine, Jan 1998:
http://www.swmed.edu/home_pages/publish/magazine/cancer/killer.html
“Choking Off Cancer”, by Rebecca Zack, TechnologyReview.com, Jul 2002
http://www.technologyreview.com/articles/02/07/innovation60702.asp?p=1
1997 Texas House of Representatives Award to Thorpe:
http://www.capitol.state.tx.us/tlo/75R/billtext/HR00210F.HTM
Technical Description of Thorpe’s APT technology:
http://www.peregrineinc.com/content.php?id=110
More on Recent Events & Technology Overview: http://www.investorshub.com/boards/board.asp?board_id=2076
Video Presentation: “Understanding Tarvacin” by Dr. Philip Thorpe, 10-25-2004:
View at: http://www.peregrineinc.com/content.php?id=174
Transcript: http://www.investorshub.com/boards/read_msg.asp?message_id=4440307
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