BioTech Research Leadership:
Spectrum Pharmaceuticals formerly NeoTherapeutics, Inc. is a leading edge specialty pharmaceutical company with alliances to Pfizer, Inc. (Licensed Genomic Properties), and Bristol-Myers Squibb (License/Supply of Elsamatrucin). The following drugs are currently under clinical development: Satraplatin (Prostate cancer: Co-development with GPC Biotech., Inc.), EOquin™ (Superficial bladder cancer, radiation sensitizer), Neotrofin (Chemotherapy-Induced Peripheral Neuropathy) and Elsamitrucin (Non-Hodgkin's lymphoma).
Neotrofin™ - An advanced nerve growth factor mediating drug
"A single dose of Neotrofin reproducibly results in a statistically significant increase in the number of stem cells in the brains of adult mice," said Eve Taylor, Ph.D., Director of Biomolecular Pharmacology at NeoTherapeutics. "This effect has now been observed in three separate studies using state-of-the-art quantitative digital microscopy techniques.

Initial Indication: Chemotherapy-Induced Peripheral Neuropathy.

Secondary Indication: Parkinson's Disease.

Route of Administration: Oral.

Mode of Action: Not clearly delineated. Animal data is suggestive of neuroprotective and nerve sprouting effects are mediated through several nerve growth factors induced by Neotrofin.

Properties: Has been administered to over 2000 patients with Alzheimer's Disease. Low toxicity.

Status: A Phase 2 study is currently ongoing in the U.S. for Chemotherapy-induced peripheral neuropathy. Enrollment has been competed for this study.
NeoTherapeutics, Inc. announced data from two studies on the acute and neuroprotective effects of Neotrofin in animal models of Parkinson's disease. In the pre-clinical studies, the data demonstrated that Neotrofin caused an acute improvement in motor function in rats. These pre-clinical studies support the recently reported positive preliminary clinical results from a human phase 2 study of Neotrofin in patients with early stages of Parkinson's disease. The phase 2 study of Neotrofin in Parkinson's disease was recently completed and preliminary results demonstrated a statistically significant acute effect on motor function for up to two weeks of treatment. A follow-up study for Neotrofin in Parkinson's disease is under development. With a single dose of Neotrofin(TM) researchers report stem cells increased by 32% in brains of mice treated.

Neuropathy Market: Currently there are no pharmaceuticals available to specifically treat chemotherapy-induced peripheral neuropathy. The potential world market for this condition is estimated to be about $1 billion.

RegeneRx Biopharmaceuticals - Lead Compound: TB4.

Medical Application: Inflammation or damage associated with myocardial events is treated or prevented by administration of an angiogenesis-inducing, anti-inflammatory peptide such as Thymosin beta 4, an isoform of Thymosin beta 4 or oxidized Thymosin beta 4.

Background: RegeneRx is a public company founded in 1982 by Dr. Allan L. Goldstein, Professor and Chairman of Biochemistry and Molecular Biology at The George Washington University Medical School in Washington, D.C. He is also Chairman and Chief Scientific Advisor of the Company. The Company's stock is traded on the OTCBB under the symbol RGRX. For the past several years, the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health (NIH), has conducted a research program to evaluate Tß4 as a wound healing and anti-inflammatory agent. The results of this research has led to the filing of world-wide patent applications related to Tß4. In February 2001, the Company secured an exclusive world-wide license from NIH relating to all intellectual property covered under the patent applications. Separately, the Company has an agreement with The George Washington University for the exclusive license for the use of Tß4 for septic shock and the down-regulation of a number of inflammatory cytokines. RegeneRx has also filed other patents relating to its product. Product Development The Company intends to independently develop Tß4 for the wound healing market and enter strategic alliances in other markets wherever possible. In that regard the Company has begun exploratory discussions with several pharmaceutical companies.


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Controlled Hyperthermia treatment is being used successfully by the oncological team at The University of Texas MD Anderson Cancer Center for end-stage metastatic disease.

Infrared whole body hyperthermia:

“Fever is the organism’s struggle to rid itself of illness; it purifies the body like a fire” Hippocrates (460-377 b.c.)

“Give me the power to create fever and I will cure all illnesses” Parmenides (540-480 b.c.)

Fever has been nature's method of healing for millions of years ...

Billions of antibodies incessantly comb through our organism, destroying dangerous bacteria, viruses, parasites and cancer cells. Our immunological system protects us all the time - and we scarcely even notice. It doesn't just protect us against everyday hazards. If the infectious agents become too numerous and too aggressive, the immunological system can resort to a powerful weapon - fever.

Fever mobilizes the body's defensive mechanisms, boosts the supply of oxygen and nutrients to the cells, improves the removal of by-products from the metabolic processes and the toxins which accrete in the body and gains the upper hand over the infection, frequently within a short space of time.

Infrared whole-body hyperthermia harnesses this most admirable of nature's mechanisms to stimulate and sustain the body's obstructed self-healing powers, so that they can tackle even chronic and malignant disorders. Whole-body hyperthermia has now been placed at our disposal by scientific research and state-of-the-art technology.

The clinically employed hyperthermia systems:
  • utilize the natural heat of the sun in the form of short-wave infrared light
  • employ a specific combination of IR emitters and reflectors to ensure especially uniform and intensive deep-heating of the organism
  • permit controlled increases in body temperature from mild overheating to high fever
  • can be combined very effectively with other physical and medication-based therapy measures
  • have established an impressive record in medical applications in the course of recent years
  • cover a wide range of indications matched by treatment

Intensity:
From prophylaxis and wellness to adjuvant treatment of life-threatening illnesses. There's more than one kind of hyperthermia.

Temperature is the distinguishing factor:
Mild hyperthermia - core temperature elevated to approximately 38.5°C
Authoress, non-articular rheumatism syndrome, chronic muscular cramps, chronic pains, high blood pressure, wellness, prophylaxis. Unlike conventional heat treatments (sauna, mud packs), medical infrared whole-body hyperthermia offers controlled temperature elevation across a defined time window. The body is deep-heated, even patients suffering stubborn, therapy-resistant disorders enjoy relief.
Moderate hyperthermia - core temperature elevated to 38.5 - 40.5°C
Chronic inflammations, particularly of the intestines and the respiratory system, bronchial asthma. Chronic inflammations are due to local abnormal reactions of the body's defensive system. As a rule, standard medication-based therapies (cortisone) can do little more than ease the symptoms. Hyperthermia, in contrast, delivers an activating impulse to restore balance in the abnormally reacting system.

Carcinoses:
Fever temperatures up to 40.5°C do not result in direct thermal damage to cancer cells. Moderate whole-body hyperthermia, therefore, is not a substitute for oncolytic standard therapies. It can, however, boost their effectiveness and improve the organism's defensive condition. This can be crucial in stopping residual cancer cells from developing into tumors (recurrences). In particular, whole-body hyperthermia can be used in cases of metastasized carcinoses against which standard therapies are no longer effective, or fail to achieve the desired effect. Extreme whole-body hyperthermia treats carcinoses by attaining "unnatural" temperatures as high as approximately 42°C. This treatment calls for incomparably more intense monitoring than the moderate form. The risks and side-effects, too, are much more pronounced, so it is used only in specially equipped centers.

How often? How long?
Mild and moderate whole-body hyperthermia is usually performed in series of between three and twelve sessions. Sessions generally last one to three hours, although some special forms of therapy involve sessions lasting up to six hours. Whole-body hyperthermia, just like any other reputable form of therapy, is not a cure-all, and this applies to the ranges of indications described above, and to all others as well. The decision whether to use hyperthermia and the decision on treatment intensity are made on a case-to-case basis taking all relevant factors into account, following in-depth diagnosis and paying all due consideration to the patient's physical condition.

Did you know?
Whole-body hyperthermia used to be a standard therapy for treating chronic infections and inflammations - until the development of antibiotics and corticoids.
A relationship with very feverish infections is suspected in a remarkably large number of spontaneous recoveries from cancer.
An above-average number of persons who suffer from cancer did not experience a very feverish infection over a period of many years.
The latest results obtained in basic research in the USA indicate that "fever-range whole-body hyperthermia" can play a major role in helping the immunological system identify cancer cells more effectively (unmasking). Clinical studies now in progress at universities in the USA are using hyperthermia units.


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