Theratechnologies - eine Chance?! - 500 Beiträge pro Seite

[greenhorn1998]

Hallo zusammen!

In einem anderen Thread (Prana) ist vor kurzer Zeit ein Unternehmen zur Sprache gekommen, das ich hier und heute einmal kurz vorstellen möchte. Theratechnologies!

Hier zuerst einige Daten zur Aktie: Gehandelt wird die Aktie zwar auch in Frankfurt (WKN 915439), aber da findet kein Umsatz statt. Heimatbörse ist Toronto, das kanadische Kürzel ist „th“. Das kanadische Unternehmen bringt derzeit eine Marktkapitalisierung von rund 60 Millionen Euro auf die Waage. Knapp 31 Millionen Aktien sind ausgegeben.

Was macht Theratechnologies? Zunächst ein kleiner Überblick:

„Theratechnologies is a Canadian biopharmaceutical company engaged in the discovery and development of therapeutic products for the treatment of endocrine and metabolic disorders. The Company`s products are currently at various stages of development, ranging from discovery to Phase II clinical trials, and target catabolic (loss of the body`s synthesis and regeneration capacity) and metabolic disorders as well as osteoporosis and diabetes. This portfolio ensures Theratechnologies continuity and increased potential for success.
ThGRF, a growth hormone-releasing factor analogue, is Theratechnologies` most clinically advanced product. It is well-suited for the treatment of catabolic and metabolic disorders and presents a very good safety profile. ThGRF has reached certain key milestones of its extensive Phase II clinical program and Theratechnologies has already deployed a global partnership strategy for the development, commercialization, manufacturing and transdermal administration of this product.
Theratechnologies` osteoporosis program is based on the development of a transdermal formulation of parathormone (PTH), known for its bone-forming effects. This product is undergoing an accelerated development program.
Theretechnologies type II diabetes program targets the development of a GLP-1 (glucagon-like peptide-1) analogue, presenting a mechanism of action that could prevent hypoglycemic complications. The Company is also working on other peptides in the therapeutic field of diabetes, namely non-acylated ghrelin and a glucagon antagonist.
In developing its products, Theratechnologies relies on its expertise with peptides, recognized for their efficacy and their reduced risk of side-effects due to their specificity. The Company has distinguished itself in the field of endocrinology through the quality of its team and products, the discovery capabilities of its two innovative technologies and its international scientific network. Moreover, Theratechnologies, a well-capitalized company, has attained the required critical mass to conduct its activities in this field.
Theratechnologies` subsidiary, Celmed BioSciences, is engaged in the field of cell therapy targeting certain cancers and central nervous system disorders using autologous adult stem cell grafts. Theralux™, an ex vivo photodynamic treatment of cancerous, alloreactive and autoimmune cells, currently targets chronic myeloid leukemia, non-Hodgkin`s lymphoma and graft-versus-host disease. The Neuro platform targets Parkinson`s disease through the autologous transplantation of neural stem cells.“



Als sehr aussichtsreich ist wohl derzeit das ThGRF-Programm des kanadischen Unternehmens. Ein Protein, das in verschiedenen Gebieten zum Einsatz kommen könnte, so z.B. zur Behandlung von HIV-bedingter Lipodystrophy – Fettleibigkeit, um es etwas frei zu übersetzen. Ich hoffe, das ist jetzt nicht grundverkehrt. Vor einigen Tagen kamen Phase II-Testergebnisse, die sehr gut ausgefallen sind:

April15, 2004
Theratechnologies Reports Phase II Results for ThGRF in HIV associated Lipodystrophy
Compound reduces visceral fat with good safety profile
Theratechnologies (TSX:TH) today announced exciting results for its Phase II clinical trial, testing ThGRFin patients with HIV-associated lipodystrophy, a medical condition characterized by body composition changes and metabolic abnormalities. Highlights include a good safety profile, a clear positive effect on body composition and a clinically relevant reduction in visceral fat while subcutaneous fat was preserved. While this selectivity of action on fat distribution appears to have prevented the study from meeting one of its primary endpoints, it likely would be an advantage in treating HIV- associated lipodystrophy patients who generally experience an accumulation of visceral fat (lipohypertrophy), associated with higher risk of cardiovascular disease, coupled with a loss of subcutaneous fat (lipoatrophy).
Of particular importance in this study was good glycemic control, including in glucose-intolerant and diabetic patients, who represented 28% of the subjects enrolled. It is estimated that approximately 40% of all HIV-associated lipodystrophy patients are either glucose intolerant or diabetic.
Based on these positive results, the Company and its clinical experts consider that ThGRF is well-suited for Phase III testing as a novel approach to treat HIV lipodystrophic patients with excessive visceral fat, an unmet clinical need.
"The results of this study are important and suggest ThGRF as a potentially beneficial treatment for HIV-associated lipodystrophy", said Dr. Steven Grinspoon, Director, Program in Nutritional Metabolism, Associate Professor of Medicine, Harvard Medical School and Lead Investigator for the US. "The selectivity on visceral fat mass as well as the decrease in the VAT/SAT ratio are noteworthy in this regard, and suggest that the physiological mode of action of ThGRF translates into clinical advantages over other approaches for patients with HIV-associated lipodystrophy. ThGRF may also prove useful to alter fat distribution from the trunk and viscera in non-HIV-infected patients with the metabolic syndrome."
Preliminary Results
Effects on IGF-1 and body composition - a key objective of the study was to determine if ThGRF had the desired endocrine activity and overall effects on body composition in this patient population. The results indicate that it does. At the 2 mg dose:
 Marked increase in IGF-1 levels (+80%, P < 0.01 vs placebo).

 Highly significant effects on body composition (lean body mass: +1.7 kg, P < 0.01 vs placebo; total body fat mass: -1.4 kg, P < 0.02 vs placebo).
Efficacy and primary endpoints - the two primary endpoints of the study were visceral fat (VAT) and the trunk/limb fat ratio. VAT is the fat specifically located within the abdominal cavity and is the fat most associated with cardiovascular disease, whereas the trunk/limb fat ratio is a measure of the relative amount of total trunk to extremity fat. These parameters were selected based on previous trials performed with high doses of recombinant human growth hormone (rhGH). The results indicate that ThGRF may be more selective than originally expected, concentrating all of its effect on visceral fat, while preserving subcutaneous fat, both at the abdominal and the peripheral levels. At the 2 mg dose:
 Body fat was preferentially lost at the trunk level (-1.1 kg, P < 0.02 vs placebo), with no significant change in limb fat.

 Within the trunk, this fat loss took place solely in the visceral compartment (VAT, -15.7%, P <0.05 vs baseline, NS vs placebo; placebo: -5.4%, NS vs baseline), whereas no change or trend thereof was observed at the subcutaneous level (SAT).

 The trunk/limb fat ratio was only modestly reduced in the treated patients. This result reflects the selectivity of ThGRF, which did not reduce subcutaneous fat at the trunk level. In line with these findings, VAT/SAT, a ratio that more accurately reflects the specificity of the treatment on visceral vs subcutaneous fat, was decreased by 17.5% (P < 0.05 vs baseline; NS vs placebo), as compared with a reduction of 1.7% in the placebo group (NS vs baseline).
Lipid Profile - the results suggest that the lipid profile improved during treatment, based on a statistically significant overall treatment effect (P <0.02 vs placebo) over the study period in the total cholesterol to HDL cholesterol ratio (known as atherogenic index), which was reflected at Week 12 by an average decrease of 0.34 in the 2 mg group compared to an average increase of 0.21 in the placebo group.
Globally, time and dose-related effects between the 1 mg and 2 mg groups were seen for most efficacy parameters during the treatment period.
Safety - due to the fact that a significant portion of the HIV-associated lipodystrophy patient population is glucose intolerant, the safety profile of growth hormone therapy is a limiting factor in this indication. It was therefore important to confirm the safety profile of ThGRF in this regard.
 28 percent of the patients presented with impaired glycemic control at entry into the study. No patients discontinued treatment due to deterioration in this condition or required medical intervention for their impaired glucose tolerance or diabetes condition.

 No significant or clinically relevant change in fasting blood glucose or on glucose levels 2 hours following an Oral Glucose Tolerance Test was observed, suggesting that ThGRF did not clinically alter the glycemic control in the study patients.

 The number of patients experiencing adverse events or clinical laboratory abnormalities was similar between the three groups. Apart from a possible higher incidence of headache and paresthesia, no clear treatment effects were observed. A similar number of patients prematurely discontinued the study across the three groups.

 No ThGRF antibodies were found in any of the patients at the end of the treatment period.
"Despite the relatively low number of patients, this study provides us with the important information that we were looking for at the time of its inception approximately one year ago, " said Dr. Julian Falutz, Director, HIV Metabolic Clinic, Montreal General Hospital, Assistant Professor, McGill University Medical School, and Lead Investigator for Canada. " Based on these preliminary results, ThGRF presents the essential components of a potential treatment for the management of HIV patients with lipodystrophy and increased abdominal girth, a major risk factor for premature cardiovascular disease, and altered body image. The absence of major safety concerns, particularly in patients with impaired glucose tolerance, as well as the apparent lack of significant toxicities, in conjunction with the positive selective effects on body composition, makes this treatment very attractive. I fully anticipate further positive developments in the ongoing investigation of this new addition to our therapeutic armamentarium against the challenge of the HIV lipodystrophy syndromes."
Luc Tanguay, President and Chief Executive Officer of Theratechnologies, concluded, "We launched this study less than a year ago in order to determine quickly whether our ThGRF could be a novel treatment strategy for HIV-lipodystrophy. The idea was to assess safety and obtain preliminary efficacy data. We ended up with much more: the reduction in visceral fat, the selectivity of action, and a good safety profile, even among glucose intolerant patients. In our minds, ThGRF is clearly a promising candidate for late-stage development in this indication."
About HIV- associated Lipodystrophy
HIV-associated lipodystrophy is a metabolic syndrome that afflicts a significant percentage of HIV patients undergoing antiretroviral therapy to control their HIV infection. Although the exact cause of this syndrome is unknown, it is suspected to be partly due to the HIV treatment itself. It is characterized by changes in distribution of adipose tissue (fat-containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include: lipohypertrophy, which is the accumulation of visceral adipose tissue, a risk factor for cardiovascular disease and type II diabetes; and lipoatrophy, which is the loss of subcutaneous fat, generally in the limbs and facial area. In addition to the direct health risks, the resulting body abnormalities can stigmatize patients and discourage compliance with their HIV regimens. There is currently no approved treatment for this condition, and although some new HIV treatments have shown signs of reducing dyslipidemia and the lipoatrophy components of the disease, the lipohypertrophy component remains an important unmet medical need. It is estimated that, among the 1.4 million HIV- positive patients in North America and Europe, as many as 250,000 suffer from HIV-associated lipodystrophy with excess visceral fat.
About the HIV- associated lipodystrophy study
The double-blind, randomized, placebo-controlled study was conducted in seven centers in Canada and the United States. In total, 61 patients were enrolled in parallel groups who received a daily subcutaneous injection of 1 mg, 2 mg or placebo, over a period of 12 weeks. The study population consisted of 89% of male patients with a mean age of 45 years. All patients were on stable antiretroviral therapy. Their average BMI was 28 kg/m2, their mean waist circumference 101 cm and their mean waist/hip ratio 1.0.
About ThGRF
ThGRF is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsatile fashion. This property makes it a strong candidate as a potential treatment for many diseases related to aging and obesity, as these conditions are characterized by a significant reduction in growth hormone secretion.


Nun, die Aktie hat darauf auch sehr positiv reagiert, um die Gewinne im Handelsverlauf doch wieder abzugeben. Neoe hat mir folgenden Kommentar zur Verfügung gestellt:

Reuters
UPDATE - Theratech`s phase II trial shows positive results
Thursday April 15, 1:30 pm ET
By Rajiv Sekhri

(New throughout, adds analyst, company comments, share price)
TORONTO, April 15 (Reuters) - A small protein made by Theratechnologies Inc. (Toronto:TH.TO - News) cuts fat levels significantly in HIV patients suffering from lipodystrophy, an unnatural redistribution of body fat, the company said on Thursday.
Results from a phase II trial of Theratech`s ThGRF compound, which stimulates the secretion of growth hormone in the body, pushed up shares of the company as much as 9 percent on the Toronto Stock Exchange (News - Websites) .
In the study involving 61 people, a group of about 20 patients who were given a 2 milligram injection of ThGRF lost 1.1 kilograms of visceral fat on average, after a 12-week period, the company said.

Visceral fat, which surrounds organs, is different from subcutaneous fat -- which you can pinch. Some patients undergoing HIV therapy see increases in visceral fat, which raises their risk of cardiovascular diseases or diabetes, and can also affect their response to HIV treatments.

"I think the results are quite positive," said Shameze Rampertab, an analyst at Jennings Capital in Toronto. " It works on visceral fat and does not (affect) subcutaneous fat, which I thought was interesting."

Theratech said ThGRF was also safe in patients who were glucose intolerant, about 28 percent of its trial`s population. Glucose intolerance can lead to adult-onset diabetes.

Swiss biotechnology firm Serono SA (SEO.VX), in results disclosed in March, said that its drug Serostim also prompted a decrease in visceral fat among patients with HIV-related lipodystrophy. However, its study did not include glucose-intolerant patients.

"The absence of major safety concerns, particularly in patients with impaired glucose tolerance, as well as the apparent lack of significant toxicities, in conjunction with the positive selective effects on body composition, makes this treatment very attractive," said Dr. Julian Falutz, director of the HIV Metabolic Clinic at Montreal General Hospital and the lead Canadian investigator on the trial.

Shares of Theratech, which have fallen 14 percent in the past year, rose 1.7 percent, or 6 Canadian cents, to C$3.57. More than 275,000 shares changed hands, much higher than the 90-day average volume of 100,000 shares.

Theratech said it was still deciding whether to start a final phase III trial for ThGRF in HIV-related lipodystrophy.

Its other option is to begin a pivotal trial of ThGRF in chronic obstructive pulmonary disease. However, results from a phase II COPD trial were mixed. Patients receiving ThGRF showed statistically significant increases in lean body mass. But there was no significant demonstration of functional improvement in patients.


Ich lasse das mal so dahingestellt. Möchte schwerpunktmäßig vor allen Dingen erst einmal Fakten zusammenstellen.

Dazu gehört auch, dass im vergangenen Februar in Theratechnologies investiert wurde. Und nicht zu knapp. Ein sehr positives Zeichen.

February 17, 2004
Theratechnologies closes $13 627 500 bought deal
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES.
Theratechnologies (TSX:TH) announces today that it has successfully completed its recently announced offering of 3,950,000 common shares to a group of underwriters led by Desjardins Valeurs Mobilières Inc. at a price of $3.45 per share thereby raising $13 627 500. The underwriters also have an option, exercisable within 30 days of the closing date, to acquire an additional 592,500 common shares for purposes of covering over-allotments and for market stabilization
The common shares have not been and will not be registered under U.S. securities laws or state securities laws and may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from such registration requirements. This communication shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sales of these securities in any state in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Hier nun noch ein Link zu einer PDF-Datei auf der Homepage von Theratechnologies (www.theratech.com). Ein gelungener Überblick über das Unternehmen, der zum einen eine sehr ausgewogene Produktpipeline zeigt, die Milliardenmärkte anspricht, zum anderen auch auf die fürs erste komfortable Cash-Situation hinweist.


http://www.theratech.com/english/investors/fact_sheet.pdf


Das ist aber auch noch nicht alles. Ein kleines Bonbon wäre da noch und das heißt Celmed Biosciences (www.celmedbio.com) . Auch hier zunächst ein Profil:

„Celmed BioSciences, a private Canadian biopharmaceutical company, is a leader in the fields of cell therapy, oncology/hematology and neurology. Created in June 2001 by Theratechnologies (TSX: TH), the Company has facilities in Canada and the United States. Celmed develops therapies based on a photodynamic process for the treatment of hematological and immune diseases as well as a technological platform to treat neurodegenerative disorders.
Photodynamic therapy (PDT) is designed to treat blood cancers, leukemias, graft-versus-host disease and autoimmune diseases. It relies on the Theralux™ technology, a photodynamic process initially designed to purge cancer cells from grafts to prevent relapse after transplantation. Human clinical trials targeting chronic myeloid leukemia (CML) and non-Hodgkin`s lymphoma (NHL) were designed to show the safety and specificity of this technology. Further preclinical research in graft-versus-host disease (GvHD) opened new possibilities in allogenic transplants, by showing that Theralux™ can prevent graft-versus-host problems, while preserving the immune response and the anti-cancer effect that are sought in bone marrow transplants. Such findings establish Theralux™ as a versatile platform, appropriate for a broad range of potential applications, including treatment of autoimmune diseases.
In the field for neurodegenerative diseases such as Parkinson`s disease, Celmed`s technology is based on the autologous transplantation of adult neural cells. This cutting-edge technology isolates a patient`s own stem cells and induces their proliferation and differentiation into the required cell type for curative or prophylactic treatment. This approach holds great promise in the treatment of several other degenerative disorders such as spinal cord injuries and conditions affecting the central nervous system, notably stroke, Huntington`s disease and Alzheimer`s disease.“


Wie es schon geschrieben steht, ist Celmed ein Spin off von Theratech. Theratechnologies hält 61,6%. Schwerpunkte sind Onkologie und Neurologie. Auch hier gibt es eine sehr informative PDF-Datei:

http://www.celmedbio.com/english/investor/fact_sheet.pdf

Ich halte mich sehr bewusst mit Kommentaren zurück. Ich bin gerade erst dabei, mich ein wenig näher mit Theratechnologies zu beschäftigen. Ich finde das Unternehmen aber sehr interessant und stelle es damit mal hier ins Biotech-Forum zur Diskussion. Ich gehe weiß Gott nicht davon aus, das Thema erschöpfend behandelt zu haben. Ich hoffe, da machen viele Leute mit. Ich hoffe auf viele Beiträge und Meinungen. Dem Prana-Forum durfte ich ja entnehmen, dass einige Leute schon investiert sind.

Gruß, greenhorn

[greenhorn1998]

Hallo zusammen!

Noch ein paar Sätze zu Celmed Biosciences und zu deren Zell-Therapie:

With facilities in Canada and the United States, Celmed develops two technological platforms.
The first platform is based on the Theralux™, a photodynamic process designed to eradicate cancerous cells in order to prevent relapse after an autologous bone marrow graft. There are two types of bone marrow grafts and both present advantages and disadvantages. In the case of an autologous graft (when the transplant comes from the patient), the transplant carries cancerous cells, which generally cause a relapse. In the case of an allogenic graft (where the transplant comes from a donor), the donor cells, although they do not carry cancer, can trigger a violent reaction towards the host cells through immunoreactive cells. Theralux™ offers a solution to these problems as, in both cases, the Theralux™ process can selectively eradicate unwanted cells. Clinical trials in humans in indications such as chronic myeloid leukemia (CML) and non-Hodgkin`s lymphoma (NHL) aim to assess the safety, efficacy and specificity of this technology. Other pre-clinical studies on graft-versus-host disease have stretched the boundaries of allogenic graft by showing that Theralux™ can prevent this reaction while preserving the immune and antileukemic functions desired in allogenic bone marrow transplantation. This discovery establishes the many potential applications of the Theralux™ platform in a variety of potential indications, such as the treatment of autoimmune disorders.
The second platform is based on the autologous transplantation of neural cells for the treatment of Parkinson`s disease. This cutting-edge technology isolates a patient`s own stem cells and induces their proliferation and differentiation into dopaminargic neurons in order to provide the patient with key cells for curative or prophylactic treatment. This approach holds great promise in the treatment of various neural indications including spinal cord injuries and conditions affecting the central nervous system, notably stroke, Huntington`s disease and Alzheimer`s disease.

Und weiter (man achte bitte auf den letzten Abschnitt):


CHRONIC MYELOID LEUKEMIA (CML)
Some 12,000 cases of chronic myeloid leukemia were recorded worldwide in 2001. Approximately 1,000 patients, at an advanced or relapsed stage, received an autologous bone marrow transplant. It is estimated that there will be 4,400 chronic myeloid leukemia cases in 2003. CML affects mostly adults, with a low prevalence in men.
Celmed is conducting Phase I/II clinical trials in CML to evaluate the efficacy and safety of its Theralux™ platform technology. Clinical trials on CML are underway at Maisonneuve-Rosemont, Quebec`s largest transplantation centre.
Demonstrating the safety profile and the efficacy of the Theralux™ process during the course of the study on CML proved an important step for Celmed BioSciences. Indeed, it opened the way to the first research work in photodynamic therapy (PDT) and spurred the rapid advance of Phase II clinical trials in other more prevalent hematological cancer indications, notably non-Hodgkin`s lymphoma.
Recently, the Food and Drug Administration (FDA) in the United States granted Theralux™ an orphan drug status for its use in the treatment of patients with chronic myeloid leukemia (CML).

Und weiter:

NON-HODGKIN`S LYMPHOMA (NHL)
Each year, approximately 140,000 new cases of non-Hodgkin`s lymphoma are diagnosed throughout the world. Some 63,000 deaths are caused by this disease and an average of 11,000 patients receive an autologous transplantation. Compared to other cancers, the incidence in lymphomas has increased and even doubled during the last 30 years for multiple and largely unexplained reasons.
This cancer occurs when a lymphocyte, a white blood cell, undergoes a malignant change and begins to multiply, creating tumors which enlarge lymph nodes.
Celmed BioSciences is carrying out a Phase I/II clinical study on non-Hodgkin`s lymphoma in eight (8) centres in Canada, including Maissonneuve-Rosemont Hospital in Montreal.


Und noch etwas zu Parkinson, für mich ein Highlight:

PARKINSON`S DISEASE
On April 8, 2002, at the annual general meeting of American Association of Neurological Surgeons, Dr. Michel Lévesque, Vice President, Medical Affairs at Celmed BioSciences, reported that adult neural stem cells taken from a patient`s own central nervous system had been successfully used to treat Parkinson`s disease, a degenerative disorder that affects movement and speech.
This is be the first study of its kind in the world evaluating the benefits of autologous cell therapy for Parkinson`s disease. The research demonstrates that adult neural stem cells can be coaxed to become the crucial cells that produce dopamine and that those cells can function after implant.
Dopamine is an essential brain chemical, which is deficient in people who suffer from Parkinson`s disease.
Dr. Lévesque isolated adult neural stem cells from a patient, induced them to differentiate into the desired nervous system cells, and implanted them back into the patient`s brain. Since the procedure, the patient`s symptoms were reduced by more than 80%, while considerably reducing palliative medication.

Ein schönes Wochenende!

Gruß, greenhorn

[Neoe]

Hallo Greenhorn,
hab deinen Thread mit einiger Verspätung entdeckt.




Was zur Indikation von ThGRF:

Nach meinem Verständnis hat dieses Medikament einige sehr interessante Eigenschaften. Es hat die Fähigkeit zum Muskelaufbau beizutragen und erfüllt damit eine Aufgabe, die bisher nur von Wachstumshormonen erfüllt wurde, die aber einige sehr unangenehme Nebenwirkungen mit sich bringen. In einer PhaseII-Studie , die im Okt. 2003 abgeschlossen wurde, wurde dies belegt:




October 21, 2003

Theratechnologies: ThGRF a potential treatment for patients with wasting associated with COPD

Phase II clinical results support move into late-stage development

Theratechnologies (TSX: TH) today announced preliminary results for a Phase II study testing ThGRF, its growth hormone releasing factor analogue, in patients suffering from chronic wasting, or muscle depletion, secondary to chronic obstructive pulmonary disease (COPD). Highlights included positive effects on body composition (increased muscle and decreased fat), a series of converging positive findings in functional measures, and a very good safety profile. Taken together, the Company considers that the results suggest an improvement in clinical condition and provide a rationale for moving ThGRF into late-stage development in COPD wasting.

Dr. Annemie Schols is Associate Professor of Pulmonology at the Department of Respiratory Medicine at Maastricht University in the Netherlands. She is a leading authority on COPD wasting, an advisor to Theratechnologies, and an investigator in this study. "The results of this study are promising, because they demonstrate that ThGRF has the potential to bring clinical benefit in COPD patients with muscle wasting. The effects on body composition are impressive because the patients were not receiving any other rehabilitation therapy, such as exercise or nutritional intervention. Furthermore, the functional parameters that seem to respond to a short period of ThGRF treatment are those that you would expect to respond to anabolic treatment. What`s also very interesting is that the clinical benefits appear to extend to patients who have progressed into severe wasting. This is a large body of patients who are in a very serious clinical condition without satisfactory treatment alternatives. It will be very exciting, if the next large-scale clinical trial is focused on this patient group, with a longer term treatment", Dr. Schols concluded.

According to Dr. Thierry Abribat, Theratechnologies` Vice President and Chief Scientific Officer, the study findings are significant in many ways. "The effect of growth hormone on body composition has been known for more than ten years but trials in adults have surfaced safety concerns and evidence of a corresponding improvement in muscle function has been inconsistent. As such, the results we are announcing today represent a significant advance in growth hormone therapeutics and a major turning point for our product, ThGRF. Not only do the results support proceeding with COPD wasting as an indication but these data are promising with respect to other indications associated with chronic wasting such as congestive heart failure or chronic renal failure. This is also encouraging news for our two ongoing Phase II studies in hip fracture wasting and HIV-related lipodystrophy", Dr. Abribat noted.

Luc Vachon, Vice President, Drug Development, at Theratechnologies, oversaw the study and is pleased with the outcome. "With this study, we have added valuable information to our already extensive knowledge of ThGRF. In terms of primary activity, we now have confirmed that our product builds lean body mass, or muscle, and reduces fat mass. We have also obtained evidence of a set of positive clinical outcomes, which make sense from a physiological perspective; and with well over 300 patients and healthy volunteers already exposed to the product, we have a very good safety profile. We have consulted with our advisors on the results of this study and on the unmet medical need that ThGRF could address in COPD wasting. Taking all of this into consideration, we believe that there is a strong case to be made for ThGRF as a potential treatment for COPD wasting and an opportunity to move forward to a later-stage of development in this indication," Dr. Vachon concluded.


Relevant findings

In the overall population, a three-month ThGRF treatment induced significant changes in body composition:

A 50 % increase in IGF-1 levels at 1 mg (p < 0.001 vs. placebo) and 92% increase at 2 mg (p < 0.001 vs. placebo), as compared with a 6% decrease on placebo;


A significant increase in muscle mass (lean body mass; LBM), with a net average gain of 1.3 kg muscle mass in the 1 mg group (P< 0.01 vs placebo) and 0.9 kg in the 2 mg group (P< 0.02 vs placebo), as compared to an average loss of 0.1 kg in the placebo group.


A significant loss in fat mass (FM), with a net average loss of 0.7 kg fat at 1 mg (p < 0.01 vs placebo) and 0.5 kg at 2 mg (P< 0.05 vs placebo), as compared to an average gain of 0.4 kg in the placebo group.


There were no differences observed between the treatment groups in terms of safety assessments, and no sign of immunogenicity (antibody formation) was detected in any of the patients.
Interestingly, the effect of ThGRF on body composition was at least as strong in patients with the most severe wasting, which is a clinically defined group, based on their body mass index, who represented 23% of the total patient population:

An average gain in LBM of 1.1 kg muscle mass in the 1 mg group (p < 0.02 vs placebo) and 1,8 kg in the 2 mg group (p < 0.01 vs placebo), as compared to an average loss of 0.1 kg in the placebo group.


An average loss in FM of 1.1 kg fat in the 1 mg group (p < 0.05 vs placebo) and 0.9 kg in the 2 mg group (p< 0.05 vs placebo), as compared to a gain of 0.4 kg in the placebo group;
Additional assessments were conducted in order to investigate whether the expected changes in body composition translated into a functional improvement over the 3-month study period. From a preliminary evaluation of the data, including exploratory analyses, some reached statistical significance while some did not. Amongst these, the following converging findings suggest that ThGRF improved the clinical condition of these patients:

A decrease in leg fatigue during exercise endurance test (Borg Scale) at 2 mg in the overall population (p < 0.01; placebo NS, vs baseline);


A decrease in breathing discomfort during exercise endurance test (Borg Scale) at 2 mg in the overall population (p = 0.01; placebo NS, vs baseline);


A trend for an increase in the physical function score of SF-36, a quality of life questionnaire, at 2 mg in the overall population (p = 0.09; placebo NS; vs baseline);


An increase in muscle strength at the quadriceps level at 1 mg and a trend for an increase at 2 mg in patients with the most severe wasting (1 mg: p = 0.05; 2 mg: p = 0.11; placebo NS, vs baseline);


A trend for an increase in maximal pulmonary inspiratory pressure (PImax) at 2 mg in patients with the most severe wasting (p = 0.09; placebo NS; vs baseline).
These parameters are highly relevant to anabolic treatment and the objectives of this study. This is true of quadriceps strength because in COPD wasting, muscle weakness affects the leg more than the arm. Similarly, PIMax is more dependent on respiratory muscle functionality than other pulmonary parameters and both the PIMax improvement and the increase in quadriceps strength would support the observed improvement in the Borg scales (leg and breathing discomfort). Finally, the SF-36 subscale that improved is related to muscle functionality.

The next steps for ThGRF
Theratechnologies has two additional Phase II studies underway. The first is measuring the efficacy of ThGRF in the recovery of wasting patients following hip fracture surgery with results expected in December 2003. The second is measuring the lipolytic effect of ThGRF in HIV-related lipodystrophy, a metabolic syndrome, with results expected in the first quarter of 2004.

Looking to the future, Luc Tanguay, President and Chief Executive Officer of Theratechnologies said, "Today`s results add to the already promising profile of ThGRF. Our strategy has been to capitalize on the product`s unique safety profile by targeting indications above and beyond the existing US $1.7 billion market for growth hormone deficiency (GHD). We believe we now have the basis to pursue COPD wasting as an initial indication for ThGRF and our analysis indicates that this is potentially a very large market. We estimate that there are approximately three million patients with severe COPD wasting in North America, Europe and Japan.

"I want to acknowledge the hard work of our advisors, the investigators and everyone at Theratechnologies who contributed to this project and to congratulate them on the results announced today. We still have a lot to do but, with one potential indication in hand and the results of two ongoing Phase II studies to come, we are increasingly confident that ThGRF will be a very important drug in the years ahead," Mr. Tanguay concluded.

Conference call and Web cast
Theratechnologies will host a conference call for investors at 8:00 a.m., October 21, 2003. To participate in the conference call, please dial 1-800-814-4859 or 1-416-640-4127. The webcast will be accessible at http://www.newswire.ca/webcast/viewEventCNW.html?eventID=671… A replay of the conference call will be available as of October 21, 2003 at 10:00 a.m. until October 23, 2003 at 10:00 a.m. at the following number: 1-416-640-1917, passcode 21023198#. The webcast will remain available in the CNW archives for 30 days at the following link: http://www.cnw.ca/en/webcast/index.cgi?companyID=653302299

About the study
Conducted in 20 centers in Canada and Europe, this double blind, randomized, parallel group and placebo controlled Phase II study was aimed at evaluating the efficacy and safety of two doses of ThGRF (1 mg and 2 mg), administered daily over a three month period, on body composition, functional status, respiratory function and quality of life in 109 patients of 50 years of age and over.

The overall patient population was representative of a non-obese COPD population and included patients with various degrees (mild to severe) of COPD severity, the pulmonary component of the disease, as defined by the American Thoracic Society criteria, and various degrees of muscle depletion, or wasting, the peripheral component of the disease, as defined by Body Mass Index (BMI) or Fat-Free Mass Index (FFMI).

About COPD wasting
COPD is a multi-component disease, implying two major components, the pulmonary and the periphery (muscle mass). The evolution of these two components is not parallel. Several prospective and retrospective studies have clearly demonstrated that involuntary weight loss or a loss in lean body mass are independent predictors of mortality, and are associated with diminished endurance exercise capacity, impaired quality of life and increase utilization of health care costs. In this regard, ThGRF is currently developed as the first compound for the treatment of muscle depletion, or wasting, associated with COPD.

About ThGRF
ThGRF is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsatile fashion. This property makes it a strong candidate as a potential treatment for many diseases related to aging and obesity, as these conditions are characterized by a significant reduction in growth hormone secretion.

The clinical studies conducted to date, involving over 400 healthy subjects and patients, have established a safety profile for ThGRF that differentiates it from growth hormone-based products. In addition, its emerging pharmacological profile identifies two distinct mechanisms of action and two therapeutic fields, each with attractive market potential.

Because of its positive effect on the secretion of an anabolic factor known as IGF-1, ThGRF may have a therapeutic effect on catabolic states characterized by a reduction in the ability to synthesize proteins, as well as muscle wasting and cachexia, which often lead to loss of autonomy and death. The Company has undertaken two efficacy studies in this field. The first concerns catabolic states related to chronic obstructive pulmonary disease (COPD) and is the subject of this press release; the second concerns catabolic states following hip fracture in elderly patients with results expected in December 2003.


Because of its cholesterol-lowering effect and the direct lipolytic effect of growth hormone, ThGRF also has therapeutic potential in certain metabolic diseases. The Company is currently conducting a Phase II study targeting lipodystrophy related to HIV. Positive results in this indication could enlarge the field of investigation for ThGRF to include the metabolic syndrome (Syndrome X). The results of this study are expected in the first quarter of 2004.
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Besonders eine zweite Fähigkeit des Medikaments zum Fettabbau ist für die in Posting 1 erwähnte, kürzlich abgeschlossene PhaseII-Studie von Wichtigkeit. Dabei muss nochmals differenziert werden, dass ThGRF gesundheitsgefährdende Fettablagerungen im Bereich der Organe abbaut, aber dabei subkutanes ("gutes")Fett nicht angreift.




SUMMA SUMMARUM:

Theratech hat ein Medikament in der Pipeline, dass in zwei Gebieten vor dem Eintritt in die PhaseIII steht (dabei kann wohl vorerst nur eine Studie finanziert werden).

In beiden Bereichen gibt es bisher keine zureichenden Behandlungsmöglichkeiten. Bei COPD z.B. wird der Markt auf 1,7 bis 2,5 Milliarden Dollar geschätzt, ohne Konkurrenz.
Konkurrenz gäbe es im Falle das Theratech die PhaseIII für Lipodystrophy bei HIV initiiert. In Europa und den USA gibt es 250,000 Personen, die unter diesem Problemen leiden. Hier hat Serono einen Kandidaten, ebenfalls mit abgeschlossener PhaseII, allerdings hat Theratech detailliertere Studienergebnisse vorgelegt als Serono.

[cristrader]

Hallo!

Theratechnologies - Sehr interessantes Unternehmen!

Bin bei meiner Aeterna Recherche darauf gestossen:
Aeterna Labs (AELA) hat diese Woche ein Phase I-Test für sein EP-1572 Wachstumshormon Secretagogue (Growth
Hormone Secretagogue(GHS)), ein neuer oral verfügbarer peptidomimtik
Wirkstoff der direkt die Wachstumshormon-Sekretion der Hirnanhangsdrüse
stimuliert, bekannt gegeben. Thread: AEternas Tochtergesellschaft Zentaris kündigte den Beginn einer Dosierungs-Bereich Studie f&uum

Hier dazu eine interessante Info:

AEterna (AEL), de Québec, vient jouer dans les plates-bandes de la biotech montréalaise Thératechnologies (TH) en lançant un programme de développement sur un médicament qui stimule la production naturelle d`hormone de croissance.

La filiale allemande d`AEterna, Zentaris, a entrepris hier une étude de phase I sur l`EP-1572, qui a des ressemblances avec le médicament vedette de Theratechnologies, le Th-GRF.

Les deux médicaments visent à traiter diverses maladies qui arrivent - surtout avec l`âge - quand l`organisme produit moins d`hormone de croissance. À l`âge adulte, cette hormone devient une « hormone de maintenance » impliquée dans l`entretien d`une foule de fonctions biologiques.

Le médicament d`AEterna fait appel à un mécanisme d`action différent de celui de Theratechnologies, « mais semble avoir un effet semblable, soit de stimuler la production naturelle d`hormone de croissance », a dit Gilles Gagnon, le président d`AEterna. Cette hormone est sécrétée par une glande du cerveau.

« C`est une étude de phase I, sur des volontaires en santé, qui vise à trouver le bon dosage et vérifier que notre molécule n`est pas toxique », a dit M. Gagnon. Il a ajouté que les coûts de développement de l`étude clinique sont absorbés par un partenaire européen, Ardana BioScience, une petite pharmaceutique écossaise.

« Selon ce que nos chimistes allemands nous disent, l`EP-1572, notre molécule, semble avoir un effet à une dose minime, ce qui laisse croire qu`il y n`y aura pas de problème de toxicité. »

Chez Theratechnologies, personne n`avait l`air de se ronger les ongles hier. Peter McBride a noté que plusieurs autres firmes ont essayé des molécules synthétiques ayant le même mécanisme d`action que l`EP-1572 d`AEterna: « Novo Nordisk et Merck ont essayé la même piste, mais ils ont eu des problèmes parce que leurs molécules déclenchaient la production de plusieurs hormones différentes, au lieu de seulement celle visée. Ce n`est pas ce que je souhaite à AEterna, mais je note simplement que c`est un problème que nous n`avons pas du tout avec notre Th-GRF, qui a un mécanisme d`action différent. »

Theratechnologies a d`ailleurs étudié à fond ce mécanisme d`action au cours de nombreuses études cliniques de phase II, un processus long et ardu qui prend des années. La compagnie a donc une longue avance et espère commencer à tester son Th-GRF en essais cliniques de phase III (la dernière étape avant la commercialisation) au début de 2005.

Mais ces études montrent qu`AEterna s`introduit dans un champ de recherche très difficile.

Theratechnologies a fait six études de phase II dont les résultats ont été mitigés.

La dernière étude, qui a utilisé le Th-GRF contre la lipodystrophie chez les sidéens, a été un succès mitigé et l`accueil des analystes a été varié. David Martin, de Dundee Securities, a abaissé son prix cible de 6,50 $ à 4,50 $. Par contre, la réputée et sévère Christine Charrette, de la Banque de Montréal, a haussé sa recommandation sur le titre à achat spéculatif (market outperform) et haussé son prix cible de 4 $ à 7 $. Mme Charrette avait été jusque-là très critique de Theratechnologies.

Google Übersetzung:
AEterna (AEL), von Quebec wird in den Plattbändern des montréalaise biotech Thératechnologies (TH) spielen, indem es ein Entwicklungsprogramm über ein Arzneimittel einführt, das die natürliche Produktion des Wachstumshormons stimuliert. Die deutsche Filiale von AEterna, Zentaris hat gestern eine Phasenstudie I über Ep-1572 unternommen, das Ähnlichkeiten mit dem Arzneimittel Schnellboot von Theratechnologies hat, Th-GRF. Die zwei Arzneimittel zielen darauf ab, verschiedene Krankheiten zu behandeln, die ankommen - besonders mit dem Alter - wenn der Organismus weniger Wachstumshormon produziert. Im erwachsenen Alter wird dieses Hormon ein "Wartungshormon", das in der Wartung einer Menge biologischer Funktionen impliziert ist. Das Arzneimittel von AEterna nimmt einen anderen Aktionsmechanismus von jenem von Theratechnologies in Anspruch ", aber eine ähnliche Wirkung zu haben, das heißt die natürliche Produktion des Wachstumshormons zu stimulieren ", hat Gilles Gagnon, scheint, der Präsident d` AEterna gesagt. Dieses Hormon wird durch glande des Gehirns abgesondert. "Es ist eine Phasenstudie I über Freiwillige in Gesundheit, die darauf abzielt, die gute Dosierung zu finden, und zu prüfen, daß unser Molekül nicht giftig ist", Herrn Gagnon gesagt hat. Er hat hinzugefügt, daß die Kosten der Entwicklung der klinischen Studie von einem europäischen Partner absorbiert werden, Ardana BioScience, ein kleines pharmazeutisches schottisch. "Was unsere deutschen Chemiker uns sagen, scheinen Ep-1572, unser Molekül, eine Wirkung an einer geringfügigen Dosis zu haben, was glauben läßt, daß es dort kein Giftigkeitsproblem geben werde. "Bei Theratechnologies hatte niemand die Luft, sich an den Nägeln gestern zu nagen. Peter McBride hat festgestellt, daß mehrere andere Unternehmen synthetische Moleküle versucht haben, die denselben Aktionsmechanismus haben, wie Ep-1572 d` AEterna: "Novo Nordisk und Merck haben dieselbe Spur versucht, aber sie haben Probleme gehabt, weil ihre Moleküle die Produktion mehrerer anderer Hormone auslösten, anstatt nur jenes anvisierten. Es ist nicht das, was ich AEterna wünsche, aber ich stelle einfach fest, daß es ein Problem ist, das wir nicht überhaupt mit unserem Th-GRF haben, das einen anderen Aktionsmechanismus hat. "Theratechnologies hat im übrigen gründlich diesen Aktionsmechanismus im Laufe zahlreicher klinischer Phasenstudien II, einen langen und schwierigen Vorgang untersucht, der Jahre dauert. Die Gesellschaft hat also einen langen Vorsprung und hofft zu beginnen, ihr Th-GRF in klinischen Phasenprüfungen III (die letzte Etappe vor der Vermarktung) Anfang 2005 zu testen. Aber diese Studien zeigen, daß AEterna sich in ein sehr schwieriges Forschungsfeld einführt. Theratechnologies hat sechs Phasenstudien II durchgeführt, deren Ergebnisse abgeschächt worden sind. Die letzte Studie, die Th-GRF gegen lipodystrophie bei den sidéens benutzt hat, war ein abgeschächter Erfolg, und der Empfang der Analytiker ist variiert worden. David Martin hat von Dundee Securities seinen Preis herabgesetzt ausrichtet von 6,50 $ bis 4,50 $. dagegen das bekannte, und strenge Christine Charrette hat von der Bank von Montreal ihre Empfehlung über den spekulativen Kauftitel (market outperform) erhöht, und hat seinen Preis erhöht abzielt von 4 $ an 7 $. Frau Charrette war dort- bis sehr kritisch von Theratechnologies.


Grüße cristrader

[cristrader]

Hier einige Links zu TH
http://www.jenningscapital.com/pdfs/TH_Feb%209%202004.pdf
http://www.rxir.com/SSI/pressrelease/200423291920.shtml

Ich setze TH mal auf meine Watchlist. Allerdings sehe ich Probleme bei der Handelbarkeit an der TSX mit der DAB. Eine fast nicht handelbare Aktie (Starpharma) reicht mir eigentlich (ca. 3-4 Tage bis Depoteinbuchung!!!)


Grüße cristrader

[Neoe]

cristrader:

Aeterna GEFIEL mir auch sehr gut, wollte einsteigen, dann haben sie verlauten lassen, dass sie eine ihrer Beteiligungen an die Börse bringen. Seither sind sie mir zu teuer, obwohl das Unternehmen sicher erste Klasse ist.

Zu Theratech:
Ich bin das Risiko eingegangen und hab sie in Deutschland gekauft. Ich hab sie ohne Aufschlag bekommen, allerdings sollte man sich auf lange Frist eindecken. Trading ist absolut unmöglich in Deutschland, da bisher fast keine Umsätze. Das wird sich aber auf Sicht von 12-24 Monaten wohl entscheidend ändern.

[cristrader]

Hallo Neoe!

Schade eigentlich mit AEterna.

In meinem Depot ist AEterna mittlerweile mit 95% gewichtet. Dazu Starpharma und eine kleine Position in Arena Pharma(ARNA). So richtig wohl fühle ich mich eigentlich nur in AEterna und sehe zurzeit kein Unternehmen mit vergleichbaren Risikoprofil und Bewertung. Ich habe aber wahrscheinlich shon zu viel Researcharbeit bezüglich Aeterna betrieben um das objektiv zu sehen.
Tip: Schau dir Aeterna nochmal etwas genauer an, besonders die aktuelle Präsentation auf der Webseite



Wie siehst du eigentlich die aktuelle Situation bei Starpharma? Ich persönlich erwarte eine wesentlich bessere Informationspolitik von einem Unternehmen



Ich handele kleinere Werte eigentlich nur an der Heimatbörse . Bin zwar grundsätzlich mittel- bis langfristig investiert, möchte aber wenn nötig sofort aussteigen können. Bei der DAB bekommt man in einigen Ländern z.B. Australien,Kanada erst 3-4 Tage nach Orderaufgabe Bescheid ob eine Transaktion geklappt hat oder nicht. In der zwischenzeit sind einem die Hände gebunden.


Sorry, ist ja ein Theratech-Thread

Chartechnisch scheint mal wieder eine Erholung fällig!



Grüße cristrader

[cristrader]

Theratech Pipeline:
http://www.theratech.com/english/investors/fact_sheet.pdf

http://www.theratech.com/francais/investisseurs/images/2003-…
http://www.theratech.com/english/investors/special_edition.p…




Celmed Pipeline:
http://www.celmedbio.com/english/investor/fact_sheet.pdf

http://www.celmedbio.com/presentations/techvest_2003.pdf



Grüße cristrader

[Neoe]

Gruß an alle:

Das Parkinson-Programm wurde übrigens (leider) von Celmed eingestampft. Grund war eine notwendige Kostenreduzierung.
Ist aber sicher richtig die Pipeline an der Stelle weiterzuentwickeln, wo man mit dem National Institute Of Health auch schon einen starken Partner gefunden hat.

[greenhorn1998]

Hi Neoe!

Das ist mir dann wohl entgangen, das tut mir leid. Konnte aber die Meldung bislang noch immer nicht finden und wäre dir dankbar, die kurz hier ins Board zu stellen.

Gruß, greenhorn

[Neoe]

Hallo und gute Nacht Greenhorn:

Die Passage stammt aus dem letzten Quartalsbericht vom 19.April:

....During the first quarter of 2004, Celmed examined the relevance of pursuing its activities in the treatment of Parkinson`s disease. Management intends to explore the many possibilities with regards to its technology pertaining to neurology. In this context, Celmed discontinued its development activities for this program and proceeded to reclassify related expenses under "Discontinued operations". For the first quarter, these expenses totaled $255,000, compared to $1,239,000 for the same period in 2003.....


Ist seit Q4 2003 im Gespräch gewesen, jetzt haben sie den Saft abgedreht. Allerdings gab es auch einige Fragen der FDA, die anscheinend nicht nur angenehm waren. Neuerliche PHASE I/II-Studien wären angeblich nötig gewesen. Da es im Neuro-Bereich sowieso mehr als pingelig zugeht, vielleicht nochmal ein Segen für uns alle, dass man in diesem Stadium abbricht, bevor wirklich die große Kohle in die Studien fliesst und dann nichts dabei rauskommt.


Also bis die Tage Greenhorn. Ich denke Theratech/Celmed ist wirklich ein gutes Investment und heillos unterbewertet. Wird gerade mal mit mit den Cashbeständen bewertet und Celmed scheint überhaupt nicht in die Bewertung mit einzugehen.

[BrauchGeld]

Gute arbeit Greenhorn und Neoe
Bin auch von Theratech überzeugt .

Grüsse
B.M.

[cristrader]

Theratechnologies` Celemed sells Celmed USA to Levesque

2004-04-26 13:47 ET - News Release

Hallo! News zu Celmed!

Dr. Andre de Villers reports

CELMED BIOSCIENCES, A SUBSIDIARY OF THERATECHNOLOGIES, FOCUSES ITS ACTIVITIES IN ONCOLOGY BY COMPLETING THE SALE OF ITS NEUROLOGY PROGRAM

Celmed BioSciences, a subsidiary of Theratechnologies, has sold Celmed USA, a private company, and its neurology assets and technology platform, to Dr. Michel Levesque. The terms of the agreement include payments of royalties on sales upon the eventual commercialization of this technology.

This transaction, which has the effect of increasing Theratechnologies` ownership from 58.5 per cent to 59.7 per cent, is in line with Celmed`s new business plan to focus on and intensify its oncology program, ultimately leading to a stronger competitive position in its field of activity.

"This transaction allows Celmed to fully concentrate its strengths and resources in oncology, while building a critical mass in this field," said Dr. Andre de Villers, president and chief executive officer of Celmed BioSciences. "In addition, we continue to seek opportunities to expand our portfolio of products because we believe that focusing on the oncology market where Celmed has already had great success will help us achieve our growth objective more rapidly," he added.

Dr. Levesque, who developed a promising treatment for neurodegenerative diseases, has been active in the field of academic neurosurgery and neurosciences research since 1986. He will continue to head the functional neurosurgery clinical program and research in central nervous system regeneration at the Cedars Sinai Hospital in Los Angeles. "I initiated this project several years ago with a good dose of faith and passion," said Dr. Michel Levesque, " ... and I believe that this transaction will help bring the autologous neural stem cells transplantation program for Parkinson`s disease to new heights and see it through important milestones with new financial partners."

About Celmed BioSciences

Celmed BioSciences is a private Canadian biopharmaceutical company in the field of oncology. Spun off by Theratechnologies in 2001, the company develops photodynamic-based therapies using its proprietary technology, Theralux. Celmed has reached several key milestones of its accelerated clinical and preclinical program for Theralux, which is currently being evaluated in three therapeutic areas -- the prevention of graft-versus-host disease, the purge of cancerous cells in non-Hodgkin`s lymphoma, and the treatment of autoimmune diseases and chronic GvHD by extracorporal photochemotherapy.



Grüße cristrader

[Neoe]

Und schon isses soweit. Sehr gute Lösung das Programm nicht einfach über Bord zu kippen, sondern zu verscherbeln. Zukünftige Tantiemen sind ebenfalls drin, sollte was zugelassen werden und der Anteil von Theratech an Celmed erhöht sicht dadurch auch noch.

Alles in allem sehr gut, nur weiß ich wirklich nicht genau was man von Theratech erwartet, der Kurs ist ja wie festgeknotet.

Vielleicht kommt es bald zu einem Einstieg eines großen Pharma-Konzerns, man wollte ThGRF ja eigentlich mal auslizenzieren nach PhaseII. Leider bezweifle ich, dass im Moment gute Konditionen auszuhandeln sind, da eine PhaseII ja in die Hose ging, dass führt zu einem erhöhten Risiko für jeden Partner.
Musste erst heute eine bittere Pille bei Antisoma schlucken, hat mir mal wieder das Risiko bei den Biotechs vor Augen geführt.

[cristrader]

Hallo Neoe!

Lies dir diesen kurzen Research-Report durch.
http://www.jenningscapital.com/pdfs/TH_Feb%209%202004.pdf

Bought Deal Questions We met with senior management of Theratechnologies last week to discuss the current bought deal of $13.6 million ($15.6 million with overallotments), expected to close on February 17. In preparation for this meeting we spoke with a number of disgruntled investors. Their concerns are summarized below and were presented to management: 1. Why finance at these levels if the upcoming, potentially positive ThGRF HIV Lipodystrophy trial results are expected at the end of March? 2. Why finance if a potential strategic partner is waiting on the sidelines with a significant upfront payment and milestones? 3. Unconsolidated, Thera had about $45 million in cash at the end of Q3, representing a healthy 2.5 years of cash. Why dilute shareholders when the stock is trading marginally above its 52-week low? Bought Deal Rationale Luc Tanguay, CEO, was formerly CFO of Thera, and is therefore finance oriented. Mr. Tanguay felt a bought deal represents money that is readily available in a good financing market. The financing window for biotech companies is known to slam shut quickly and not open for years at a time. This additional cash is considered to be an insurance policy in the event of the closing of the financing window. Add to this management’s comment that the current bought deal was cut back to the $15 million level. No guidance was provided as to demand level. Also, most of the investors are from Ontario and the US, which should broaden the investor base beyond Quebec. Management was similarly criticized in their last financing for $30.6 million in December 2001, which was also a bought deal. In the previous financing, it occurred at the tail end of a very good biotech financing window. We believe Mr. Tanguay’s rationale is not apt in the current situation. We believe the financing opportunities will exist until at least the end of this year, as we have yet to see the first biotech IPO. The company has planned and is expected to do a further, more significant financing at a higher valuation later in 2004. The upcoming ThGRF HIV Lipodystrophy trial results should provide momentum for the stock in the short term. We continue to recommend Theratechnologies as a BUY with a 12 month target price of $4.50.

Schätze die Kapitalerhöhung zu Tiefstpreisen hat viel Porzellan zerschlagen. Das Vertrauen der Anleger muss erst wieder neu gewonnen werden. Für Anleger die nach dieser Kapitalerhöhung eingestiegen sind bzw. zu aktuellen Preisen einsteigen vielleicht eine einmalige Chance.

Grüße cristrader

[Neoe]

Zum Thema Finanzierung kann ich nur soviel sagen:

Man schaue sich Antisoma an, da das heute leider mein Top-Thema ist. Die haben auch im Dezember noch mal Kohle reingeholt, obwohl man eigentlich Februar schon positive Ergebnisse der Phase III haben wollte. Hat damals auch nicht jeder verstanden, da jeder mit unmittelbar höheren Kursen rechnete. Heute ist die PhaseIII im Arsch und Antisoma wäre ein gutes Stück beschissener dran ohne die Kohle von damals.

Deswegen sind die angeführten Gründe leider nur zutreffend, wenn man davon ausgeht das alles gut geht und das ist leider, wie man sieht, nicht immer so.

Gruß an alle Theratechnologen, Neoe

[cristrader]

http://new.stockwatch.com/swnet/newsit/newsit_newsit.aspx?bi…

Theratechnologies says Thera might be a Celmed deal

2004-04-27 15:40 ET - News Release


Mr. Peter McBride reports

DISCUSSIONS AT CELMED BIOSCIENCES, A SUBSIDIARY OF THERATECHNOLOGIES

Following a recent media article, Theratechnologies has confirmed that its subsidiary Celmed BioSciences is in discussions for a possible transaction with NewBiotics of San Diego. There can be no guarantee that a transaction will result. Neither Theratechnologies nor Celmed will comment further on this initiative at this time.

WARNING: The company relies upon litigation protection for "forward-looking" statements.

Grüße cristrader

[Neoe]

Suche vergeblich den zugehörigen Artikel, auf den sich Theratech in der News bezieht.

Übernahme von Celmed durch NewBiotics, oder wat ?? Kann eigentlich nicht sein. Vielleicht wird noch irgendwas aus dem Portfolio von Celmed verscherbelt.

[greenhorn1998]

Hallo zusammen!

Hinter dem angebenen Link verbirgt sich ein Jahrsrückblick 2003 von CEO Luc Tanguay. Ist natürlich schon ein bisschen überaltet, zum Beispiel aufgrund der Mitte April veröffentlichten Phase II-Ergebnisse zu ThGRF hinsichtlich HIV-bedingter Lipodystrophy. Ich dachte, es gibt vielleicht noch einmal eine kurze Zusammenfassung, die deutlich macht, was für ein Potenzial Theratech hat. Das Unternehmenist auf dem Weg hin zu einer Late-Stage-Company nicht mehr aufzuhalten. (Auch nicht die fehlgeschlagene Hip-fracture-Phase II-Studie.)

"(...) our development strategy makes it possible to become a late-stage company in several different ways. (...)"

http://www.theratech.com/english/investors/special_edition.p…

Theratech ist meiner Ansicht nach unterbewertet, erst Recht wenn man sich noch die Beteiligung an Celmed in Erinnerung ruft. Sehr interessant!!!

Gruß, greenhorn

[Neoe]

Good News, scheiß Kurs: es bleibt (vorerst) dabei.


Celmed Biosciences, A Subsidary of Theratechnologies, Announces Interim Results of Theralux(TM) Clinical Trial In Patients With Non-Hodgkin`s Lymphoma
Thursday April 29, 3:14 pm ET


Confirms Complete Eradication of Cancer Cells from Autologous Stem Cell Grafts in 88 Percent of Patients
MONTREAL, April 29 /CNW Telbec/ - Celmed BioSciences, a subsidiary of Theratechnologies (TSX:TH - News), active in the field of oncology, today announced the interim results, of an ongoing open-label clinical study using its ex vivo photodynamic therapy, Theralux(TM), for patients with non-Hodgkin`s lymphoma (NHL). The results show that Theralux(TM), a non-invasive process used outside the body (ex vivo) to treat disorders affecting the blood and bone marrow, was able to completely eradicate cancer cells from autologous stem cell grafts in 88 percent of patients.
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The objective of the present study was to determine the safety of the Theralux(TM) process and whether the process could eliminate lymphoma cells from a contaminated graft below detectable levels in at least 50 percent of patients. Fourteen patients have been enrolled in the trial to date. They all had histologically confirmed NHL with a documented molecular rearrangement (Bcl2) in the peripheral blood or bone marrow cells that could be detected at levels as low as 5 cells per million. The efficacy of Theralux(TM) to purge lymphoma cells from contaminated grafts to below detectable levels was 88 percent (7 out of 8) in fully evaluable patients. Another analysis with all available patients showed that 77 percent (10 out of 13) patients received grafts without detectable levels of cancer cells after the Theralux(TM) therapy. The remaining 3 patients received grafts where greater than 85 percent of cancer cells were eliminated. Data from one patient was not available at the time of the analysis.

Following autologous stem cell transplantation, successful engraftment was reported in all 14 patients suggesting that Theralux(TM) did not affect the viability of precursor and progenitor cells that allow engraftment. Thirteen of the patients are still alive, and 9 patients are disease-free survivors with clinical remissions up to 39 months. Based on these positive results, Celmed plans to accelerate the completion of the study.

"Purging cancer cells from autologous stem cell grafts is currently used to reduce the possibility of cancer relapse, but new methodologies need to be developed to improve the efficacy of purging - this data suggests that the Theralux(TM) process is a most promising candidate for this application," said Dr. Denis Claude Roy, Hematologist and Director, Cellular Therapy Laboratory at Maisonneuve-Rosemont Hospital in Montreal and principal investigator of the study. "These interim results suggest that Theralux(TM) is able to target and eliminate cancer cells without compromising engraftment," Dr. Roy added.

"These positive results represent the first of several important milestones expected from Celmed over the next 12 to 18 months, including the start of additional clinical trials expanding the applications of Theralux(TM)," commented Dr. André de Villers, President and Chief Executive Officer of Celmed. "We are also building key relationships with both the medical and business communities to add further value to the Theralux(TM) technology platform. In addition, Celmed is in excellent financial position to carry out its intensified development activities," he added.

About non-Hodgkin`s lymphoma

Non-Hodgkin`s lymphoma is one of several cancers originating in the lymphatic system. It occurs when a lymphocyte, a white blood cell, undergoes a malignant change and begins to multiply, eventually crowding out healthy cells and creating tumors that enlarge lymph nodes. According to the US National Cancer Institute, over 50,000 people develop non-Hodgkin`s lymphoma every year in the US (140,000 worldwide), while approximately 25,000 die of this disease annually. Treatment for this disease includes chemotherapy and radiation, monoclonal antibody-based treatments and both allogeneic and autologous stem cell transplantation coupled with high-dose chemotherapy. Autologous stem cell transplantation with high-dose chemotherapy is often recommended for certain types of relapsed NHL. In these cases, the stem cells in the graft are often contaminated by the patient`s own cancer cells and would be reinfused into the patient if they are not first purged from the graft.

[Neoe]

Theratechnologies: Preliminary Phase I Results for ThPTH in Osteoporosis - First human testing combining PTH and ALZA`s Macroflux(R) transdermal technology
Monday May 3, 7:45 am ET


MONTREAL, May 3rd /CNW Telbec/ - Theratechnologies (TSX: TH - News) today announced positive preliminary results of a Phase I clinical study for ThPTH, its transdermal formulation of parathyroid hormone (PTH) being developed in collaboration with ALZA Corporation of Mountain View, California for the treatment of osteoporosis. The study showed that delivery of ThPTH using ALZA`s Macroflux(R) technology allows for rapid delivery of PTH, good bioavailability, biologic activity of PTH and a good safety profile.
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This first-in-humans Phase I study was designed to obtain information on safety and to determine the pharmacokinetic and pharmacodynamic profile of Macroflux-PTH patch delivery. The overall objectives were to confirm the proof of concept previously established in animals and to define the conditions for further development. In a cross-over design, a total of 20 female subjects received both a single application of a 2 cm2 Macroflux-PTH patch and a subcutaneous (s.c.) injection of commercially available PTH (Forteo(R)) at a dose previously shown to be clinically effective.

The preliminary results indicate that the Macroflux-PTH patch delivered PTH, as measured by ELISA, at blood levels in the range of that obtained with s.c. administration. Urinary cyclic AMP levels (cAMP), a known marker of PTH`s biological activity, were monitored in this study. After adjusting for the glomerular filtration, the calculated glomerular filtrate cAMP concentration increased markedly within two hours for both routes of administration. Changes were also observed for both routes of administration in other markers of PTH`s biological activity, such as serum calcium. There were no serious adverse events reported for the Macroflux-PTH treatment group. The majority of the systemic adverse events observed in both treatment groups are typical of what has been previously reported.

Full analysis of the data is currently underway and will be released at an appropriate conference later this year. Based on these preliminary results, the Company considers that continued development of the product is warranted.

Luc Tanguay, President and Chief Executive Officer of Theratechnologies, commented, "We launched this study to confirm safety, and determine the feasibility, of a patch formulation as an alternative to injectable PTH. We feel these objectives have been met and we are looking forward to moving on to calibration studies aimed at achieving bio-equivalence with subcutaneous injection."

Conference call and Web cast

The Company will hold a webcast today at 4:00 p.m. to discuss the results.

To listen in, dial: 1-416-640-4127 or 1-800-814-4859 (toll free)

A replay of the conference call will be available as of May 3rd, 2004 at 7:00 p.m. until May 10, 2004 at 11:59 p.m. at the following number: 1-416-640-1917, passcode 21049274(pound key). Please call 5 minutes prior to the conference in order to ensure your participation. The webcast will be posted for 90 days at the following links: http://www.vcall.com/CEPage.asp?ID=88146 and http://www.theratech.com/

About osteoporosis

It is estimated that osteoporosis affects approximately 30 million people in the United States, Europe and Japan. Osteoporosis is a bone disorder characterized by progressive bone loss predisposing to an increased risk of fracture, typically in the hip, spine and wrist. The progressive bone loss, which begins between the ages of 30 and 40, is mainly asymptomatic until a bone fracture occurs, leading to a high degree of patient morbidity and mortality. Eighty percent of those affected by osteoporosis are women and, during the six years following the onset of menopause, women lose one third of their bone mass. In the United-States alone, osteoporosis is responsible for more than 1.5 million fractures annually and the estimated direct expenditures (hospitals and nursing homes) for osteoporosis and associated fractures were $17 billion in 2001 or $47 million per day.

About ThPTH

Theratechnologies` ThPTH is a transdermal formulation of PTH, a hormone secreted by the parathyroid gland that regulates the metabolism of calcium and phosphate in the body. PTH has stirred great interest in the treatment of osteoporosis for its ability to promote bone formation, hence dramatically reducing the incidence of fractures. Large-scale clinical trials have shown that PTH, administered by injection, effectively and safely reduces the percentage of vertebral and non-vertebral fractures in women with osteoporosis. Theratechnologies and ALZA previously achieved excellent preclinical feasibility study results when combining parathyroid hormone (PTH) with ALZA`s Macroflux(R) transdermal technology.

About Macroflux(R) transdermal technology

Macroflux(R) transdermal technology incorporates a thin titanium screen with precision microprojections that, when applied to the skin, creates superficial pathways through the skin`s dead barrier layer allowing transport of macromolecules. Macroflux(R) technology has been designed for easy, convenient application that yields reproducible delivery of pharmacological agents.

About Theratechnologies

Theratechnologies (TSX: TH - News) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body`s synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies. Its subsidiary, Celmed BioSciences, develops photodynamic-based technologies in the field of oncology.

[greenhorn1998]

Immerhin: das Volumen ist heute mal überdurchschnittlich, bei freundlichen Kursen.

Gruß, greenhorn

[greenhorn1998]

Hallo zusammen!

Keine weltbewegenden Neuigkeiten, die ich hier verkünde. War gerade nur kurz auf der Celmed-Seite. Ich glaube, die haben ihren Internetauftritt etwas abgeändert, wenn ich das richtig gesehen habe. Den neuesten Entwicklungen angepasst.

Gruß, greenhorn

[greenhorn1998]

N`abend!

June 7, 2004
Celmed BioSciences, a subsidiary of Theratechnologies, to acquire NewBiotics
Theratechnologies (TSX: TH) announced today that its subsidiary, Celmed BioSciences, is acquiring NewBiotics Inc. of San Diego, California, in an all-share transaction. NewBiotics is a biopharmaceutical developer of cancer therapies.
The acquisition is in keeping with Theratechnologies` strategy of establishing independent subsidiaries to develop non-core programs and encouraging their efforts to grow into strong freestanding entities. Theratechnologies created Celmed in 2001 to develop its Theralux™ photodynamic therapy. Through this acquisition Celmed strengthens its pipeline by complementing its existing expertise in hematology (Theralux™) with NewBiotics` technology aimed at solid cancers.
As a result of the transaction, Theratechnologies` ownership in Celmed will be reduced from 59.7% to 42%. Consequently, Theratechnologies will no longer exercise control over Celmed. The investment held in the Company will be accounted for by the equity method.
Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies said, "We are pleased to welcome the former NewBiotics shareholders to Celmed. This acquisition represents an important step for the development of Celmed`s business and we are looking forward to continued progress in the months ahead."
About Celmed BioSciences
Celmed BioSciences Inc. ("Celmed") is a private Canadian biopharmaceutical company active in the field of oncology. Celmed develops photodynamic-based therapies to treat hematological and immune diseases using its proprietary technology Theralux™. Celmed has reached several key milestones of its accelerated clinical and preclinical program for Theralux™, which is currently being evaluated in three therapeutic areas: the prevention of graft-versus-host disease (GvHD), the purge of cancerous cells from bone marrow transplants in non-Hodgkin`s lymphoma (NHL) and the treatment of autoimmune diseases and chronic GvHD by extracorporal photochemotherapy (ECP).
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body`s synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies.Theratechnologies` website is located at www.theratech.com. The Company is listed on the Toronto Stock Exchange under the symbol TH.


Gruß, greenhorn

[greenhorn1998]

Und weiter geht`s!

June 8, 2004
Theratechnologies announces decision to advance ThGRF into late-stage development in HIV-associated lipodystrophy
Theratechnologies (TSX: TH) announced today that it has selected HIV-associated lipodystrophy as the first indication to be fully pursued in late-stage development with ThGRF, its growth hormone releasing factor analogue. The Company will proceed with the implementation of all requirements relative to this development, including interactions with regulatory authorities, with the goal of initiating a Phase III program later this year.
Prior to today`s announcement, Theratechnologies explored the therapeutic potential of ThGRF through a broad-based Phase II development program. In all, more than 600 patients and healthy volunteers participated in ThGRF trials across several indications. The studies demonstrated that ThGRF safely induces several beneficial clinical effects, suggesting that it could become a multi-indication drug with blockbuster potential. The clinical benefits noted include an anabolic effect (increased muscle mass with trends for functional improvement), lipolytic effects (visceral fat reduction and improved lipid profile), stimulation of the immune system, and enhanced cognitive function (daytime alertness).
Based on the Phase II program, Theratechnologies considered two initial development alternatives for ThGRF -- wasting associated with chronic obstructive pulmonary disease (COPD) and HIV-associated lipodystrophy.
Luc Tanguay, President and Chief Executive Officer of Theratechnologies commented: "Today`s announcement reflects our number one priority, which is to bring ThGRF to market in an initial indication as soon as possible. Looking further down the road, wasting associated with chronic disease and the various medical conditions observed with aging generally appear to us to be where the greatest long-term potential for ThGRF lies so our intention is to further develop the COPD wasting indication in keeping with available resources."
About HIV-Associated Lipodystrophy
HIV-associated lipodystrophy is a metabolic syndrome that afflicts a significant percentage of HIV patients undergoing antiretroviral therapy. It is characterized by changes in distribution of adipose tissue (fat-containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include lipohypertrophy, mainly of visceral adipose tissue, and lipoatrophy, or loss of subcutaneous fat, generally in the limbs and facial area.
In a Phase II clinical trial, ThGRF was shown to be effective in reducing lipohypertrophy, which is a risk factor for cardiovascular disease and type II diabetes. An interesting and potentially important finding was that these effects involved preferentially visceral fat, as opposed to subcutaneous fat. Importantly, patients with impaired glucose tolerance or Type II diabetes did not present clinically relevant safety concerns.
There is currently no approved treatment for HIV-associated lipodystrophy, and although some new HIV treatments have shown signs of improving metabolic components of the disease, the lipohypertrophy component remains an important unmet medical need. It is estimated that, among the 1.4 million HIV- positive patients in North America and Europe, as many as 200,000 suffer from HIV-associated lipodystrophy with excess visceral fat.
About ThGRF
ThGRF is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsatile fashion. This property makes it a strong candidate as a potential treatment for many diseases related to aging and obesity, as these conditions are characterized by a significant reduction in growth hormone secretion.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body`s synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies.


Gruß, greenhorn

[greenhorn1998]

Und nochmal ich!

June 8, 2004
Theratechnologies: Senior Management Reorganization and Changes to Board of Directors
Theratechnologies (TSX: TH), which earlier today announced that it plans to advance its flagship product, ThGRF, into Phase III development in HIV-associated lipodystrophy, is reorganizing senior management responsibilities in order to position the Company for late-stage product development and commercialization. At the centre of the plan is the recruitment a new Chief Executive Officer
Luc Tanguay, President and Chief Executive Officer, explained that the company`s priorities are shifting. "In preparation for what lies ahead, there are three important priorities that we need to address," Mr. Tanguay said. "The first is to recruit the industry experience we are currently missing in late-stage business activities and product commercialization. Second, with two products now in development and a third product about to enter development, we want to put more resources behind our business development and partnership activities. And finally, we want to integrate our research, clinical development and pharmaceutical development activities to efficiently progress products through the pipeline."
To lead the transition to a late-stage biopharmaceutical enterprise, the Company intends to recruit an industry executive with pertinent experience in downstream activities. The new CEO`s mandate will be to build on the company`s previous success by creating an organization capable of effectively managing all upcoming aspects of the Company`s pharmaceutical business, including commercialization activities.
Mr. Tanguay will continue in his current role until the CEO is in place. Thereafter, he will assume the role of Senior Executive Vice President and Chief Financial Officer. Mr. Tanguay will thus be responsible for all financial aspects of the business and most corporate activities.

Thierry Abribat, Ph.D., previously Vice President and Chief Scientific Officer will become Executive Vice President, Business Development. In his new role, Dr. Abribat will be responsible for leadership and coordination of all product-partnering activities, an area of crucial importance at this stage of the Company`s development.
Luc Vachon, Ph.D., previously Vice President, Drug Development will add research activities to his responsibilities in his new role as Executive Vice President, Research and Development. In integrating the two activities he will work closely with Krishna Peri Ph.D. formerly Director, Discovery, who becomes Vice President, Research and Pierre Perazzelli, Vice President Pharmaceutical Development.
Company Chairman, Jean de Grandpré, spoke on behalf of the Board of Directors, "Over the past two years, Luc Tanguay and his management team have been very successful in narrowing the Company`s focus to therapeutic peptides in endocrinology and metabolism, and an important outcome has been the emergence of a very promising product pipeline. We have now mapped out the next phase of Theratechnologies` evolution, which is late stage development and commercialization, and this reorganization of senior management responsibilities is aimed at getting us there quickly and efficiently. The Board intends to work closely with management to complete the new CEO recruitment as expeditiously as possible."
The Company also announced changes that will reduce the interrelationships between Boards of Directors of Theratechnologies and Celmed BioSciences following the acquisition announced by Celmed on June 7, 2004. Mr. Tanguay has resigned from Celmed `s board while Dr. André de Villers is leaving Theratechnologies` board and relinquishing his current role as Vice-Chairman. Dr. de Villers continues in his responsibilities as President and Chief Executive Officer of Celmed. In addition, Monique Lefebvre will be leaving the Theratechnologies Board and will replace Luc Tanguay on Celmed`s Board.
Mr. de Grandpré expressed the Board`s recognition of Dr. de Villers and Ms. Lefebvre, "On behalf of our shareholders, we would like to convey our gratitude to Dr. de Villers and Ms. Lefebvre for their significant contributions to the deliberations of the Board and to the progress of Theratechnologies", he said.

About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biotechnology company engaged in the discovery and development of therapeutic products in the field of endocrinology and metabolism. The Company has and is developing a portfolio of peptides at various stages of development for the treatment of catabolic (loss of the body`s synthesis and regeneration capacity) and metabolic disorders, as well as osteoporosis and type II diabetes. In addition, Theratechnologies is expanding its peptide portfolio through proven, proprietary technologies.
Theratechnologies` website is located at www.theratech.com. The Company is listed on the Toronto Stock Exchange under the symbol TH.


Gruß, greenhorn

[BrauchGeld]

Wegen dieser Nachricht ist der Kurs um über 15% eingebrochen.

Theratechnologies Announces Resignation of Senior Officer
Tuesday August 24, 4:35 pm ET


MONTREAL, Aug. 24 /CNW Telbec/ - The Board of Directors of Theratechnologies (TSX: TH - News) announced today that it has received and accepted the resignation of Luc Vachon PhD, Executive Vice President, Research and Development.
The precise date of Dr. Vachon`s departure has not been determined, as he has agreed to continue in his current position until alternative arrangements can be made. In light of the strength of Theratechnologies` R&D group and Dr. Vachon`s continued involvement on an interim basis, his departure should not affect the advancement of the Company`s drug development programs.

Dr. Vachon joined Theratechnologies in 2002 as Vice President Drug Development and has since established capabilities and expertise within the Company to cover all critical aspects of the drug development process. In accepting Dr. Vachon`s resignation, the Board thanked him for his important contribution and wished him well in his future endeavors.

[BrauchGeld]

Hoffentlich wird das bald den Kurs nach oben treiben.

Theratechnologies presents results from its HIV-associated lipodystrophy Phase II study on ThGRF at the 12th International Congress of Endocrinology
Thursday August 26, 9:17 am ET


Additional presentations to be made before year end in Europe and the US
MONTREAL, Aug. 26 /CNW Telbec/ - Theratechnologies (TSX :TH - News) announced today that results of its Phase II clinical trial on ThGRF in patients with HIV-related lipodystrophy, a medical condition characterized by body composition changes and metabolic abnormalities, will be the subject of an oral presentation at the 12th International Congress of Endocrinology in Lisbon, Portugal by Dr. Steve Grinspoon, Director, Program in Nutritional Metabolism, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School and Lead Investigator for the US. Preliminary data from the study were first released in April.
Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies, commented: "The International Congress of Endocrinology is an important reference point in our field and we are very pleased for this opportunity to present our lead compound, ThGRF, as we prepare to move the program into late-stage development. "Looking ahead," Mr. Tanguay continued, "we have a full conference agenda for the coming months and will be presenting results and updates of our other clinical and preclinical activities, notably our COPD-wasting, osteoporosis and diabetes programs."


12th International Congress of Endocrinology (Lisbon, Portugal) Aug. 31-
Sept. 4, 2004

HIV-related lipodystrophy


HIV lipodystrophy, a metabolic syndrome, affects a significant proportion of HIV patients and is often characterized by excess visceral fat accumulation, a risk factor for cardiovascular disease. Theratechnologies` ThGRF is a stabilized analogue of the natural peptide called growth hormone releasing factor. This product could offer potential in a variety of therapeutic indications without the side effects commonly associated with recombinant human growth hormone. Dr. Grinspoon`s oral presentation is entitled:

- Effects of TH9507, a Growth Hormone Releasing Factor (GRF) Analogue,
on body composition in patients with abdominal fat accumulation
associated with HIV-lipodystrophy syndrome.


These data confirm that ThGRF could represent a novel treatment strategy for HIV lipodystrophy. ThGRF has been shown to effectively improve body composition, by selectively decreasing visceral fat and yet preserving subcutaneous fat, in patients with HIV lipodystrophy including those who are glucose intolerant or diabetic. Administration of ThGRF is also associated with a good safety profile in these patients.
Type II diabetes

Theratechnologies will also present in vitro animal data for a novel target for the treatment of type II diabetes at the endocrinology congress. Sodium dependent glucose transporters (SGLTs), which are found in the kidneys, are responsible for recovering glucose from the urine and returning it to the bloodstream. Using its proprietary ExoPep discovery platform, Theratechnologies has designed SGLT antagonists that have potential to interfere with this process, thereby lowering glucose levels in the blood.


Poster Presentation:
--------------------
- Blockade of renal glucose uptake controls glycemia in normal and
diabetic animal models


Theratechnologies is pursuing a multi-target approach to type II diabetes and has other several promising peptides in its portfolio. The most advanced is ThGLP 1 (TH0318), a stabilized analogue of glucagon like peptide 1, which is expected to enter Phase I clinical development this year.

The European Respiratory Annual Society Congress (Glasgow, Scotland)
Sept. 4-8, 2004

Wasting associated with chronic obstructive pulmonary disease (COPD)


Two clinical investigators, Dr. Annemie Schols, Professor of Nutrition and Metabolism in Chronic Diseases at the Department of Respiratory Medicine at Masstricht University in the Netherlands, and Dr. François Maltais, Director of the Respiratory Research Unit at Hôpital Laval, Université Laval, in Quebec City, will present the results on body composition and functional performance of a Phase II study in patients with wasting secondary to chronic obstructive pulmonary disease.

Poster presentation:
--------------------

- Anabolic effects and safety assessment of TH9507, a growth hormone
releasing factor (GRF) analogue, in patients with COPD-associated
wasting

Poster presentation with discussion session:
--------------------------------------------

- Effects of TH9507, a growth hormone releasing factor (GRF) analogue,
on functional performance in patients with COPD

American Bone and Mineral Society Meeting (Seattle, Washington)
Oct. 1-5, 2004

Osteoporosis


Theratechnologies is collaborating with ALZA Corporation in the development of a transdermal formulation for parathyroid hormone, ThPTH, as an alternative to the injectable form. Parathyroid hormone (PTH) has stirred great interest in the treatment of osteoporosis for its ability to promote bone formation, hence dramatically reducing the incidence of fractures. The results of a first-in-humans Phase I study combining ThPTH with ALZA Corporation`s Macroflux(R) technology will be presented.

Poster presentation:
--------------------
- Administration of ThPTH to humans using Macroflux(R) transdermal
technology results in the rapid delivery of biologically active PTH.

About Theratechnologies

[BrauchGeld]

Hi

Hier ist noch eine aktie die mich etwas enttäuscht ,mal sehen ob es mit dem neuen ceo besser läuft.

Theratechnologies Receives US $12 Million for Macroflux(R) Projects and Submits Request for Meeting with FDA to Discuss Advancing Lead Compound, ThGRF
Tuesday December 21, 4:00 pm ET


MONTREAL, Dec. 21 /CNW Telbec/ - Theratechnologies (TSX: TH - News) announced today that it has received US $12 million (CAD $15 million) from ALZA Corporation of Mountain View, California (ALZA) for its interest in co- development projects using ALZA`s Macroflux(R) transdermal technology. The Company also confirmed that it has requested a meeting with the Food and Drug Administration (FDA) in the United States to discuss advancing ThGRF (TH9507), an analogue of growth hormone releasing factor, into late-stage development.
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"The actions we are announcing today are important steps towards meeting the objectives we have set for ourselves in 2005", said Yves Rosconi, the newly appointed President and Chief Executive Officer of Theratechnologies. "Advancing ThGRF is clearly the top priority for the Company because it is the single most important thing we can do in the near term to build value for shareholders. The ALZA deal supports this goal while enhancing our already strong financial position. In effect we have strengthened our cash position, lowered our burn rate, and narrowed our near-term business focus so that we can devote more time and energy to ThGRF", Mr. Rosconi concluded.

Mr. Rosconi has established four key priorities for Theratechnologies in 2005, emphasizing the need to: (1) strengthen the organization by recruiting additional experienced pharmaceutical executives; (2) tightly focus the Company`s resources on advancing ThGRF into late-stage development; (3) maintain a sound financial position; and (4) strengthen the product pipeline.

Request for meeting submitted to FDA

The Company`s lead compound, ThGRF, is an analogue of a natural hormone known as growth hormone releasing factor. ThGRF showed promising results in Phase II testing for the treatment of HIV-related lipodystrophy, a metabolic disorder that afflicts HIV patients. In recent weeks, the proposed late-stage development program for ThGRF was thoroughly reviewed in order to maximize the chances of success at both the regulatory and clinical levels. This work has now been completed and a request for a meeting has been submitted to FDA. The meeting is expected to take place in March 2005.

Agreements with ALZA

Theratechnologies had three previously announced co-development projects with ALZA Corporation utilizing Macroflux(R), a novel transdermal drug delivery technology. In return for its interest in these projects, Theratechnologies received a lump-sum payment of US $12 million (CAD $15 million). The agreement announced today has no impact on Theratechnologies existing development programs for ThGRF and ThGLP-1, which are continuing. Both of these compounds are currently being administered by subcutaneous injection and the Company intends to investigate alternative means of delivery for potential application in the future.

Outlook

"While there are many challenges still ahead, I am pleased with the progress we have made over the past two months. Our lead compound is now that much closer to late-stage development and I am very confident that we are on the right regulatory track", Mr. Rosconi stated. "The ALZA deal is about increased focus and it`s about cash. We now have close to $60 million available, enough to fund operations for over three years. This allows us to embark on the late-stage development of ThGRF without feeling pressure to issue additional shares", Mr. Rosconi concluded.

Conference call and Webcast

The Company will hold a conference call on Wednesday, December 22, at 8:30 A.M. to discuss these developments. You can access the webcast at the following links: http://www.vcall.com/CEPage.asp?ID(equal sign)90159 and www.theratech.com . The webcast will be posted for 90 days.

For the conference call, interested participants are asked to dial the following numbers: 1-416-640-4127 or 1-800-796-7558 (toll free). A replay of the conference call will be available as of December 22, 2004 at 10:30 a.m. until December 29, 2004 at 10:30 a.m. at the following number: 1-416-640-1917, passcode 21106656(pound key). Please call 5 minutes prior to the conference in order to ensure your participation.

Gruss
B.M.