Scotia Holdings PLC - die schottische QLT mit enormen Potential - 500 Beiträge pro Seite

[MRICH]

Ich möchte hier ein sehr interessantes Biotechunternehmen aus Schottland vorstellen:
Scotia Holdings PLC (www.scotia-holdings.com)

Die Aktie bewegt sich derzeit um die 2 Euro. Mit der FDA Zulassung und der Vermarktung von Foscan ab Herbst 2000 ist alles möglich.

Ich freue mich auf Eure Einschätzungen.

Pressemitteilungen (Auszüge):

PDT combines the use of non-thermal (cold) light and a chemical (photosensitiser) which is inert until exposed to light as a treatment for cancers and potentially many other diseases. The company believes that it is a leader in this field. Scotia`s lead product Foscan, has been assigned fast-track designation for the review of its palliation study by the US FDA. The NDA file submission is anticipated by the end of September 1999.

Scotia has licensed Foscan to Kyowa Hakko in Japan.

****
Scotia Holdings PLC Preliminary Results for the Year Ended 31 December 1999

Scotia Holdings PLC ("Scotia") announces its preliminary results for the year ended 31 December 1999.

Highlights

* Foscan filings completed on schedule in US and Europe for palliation of head and neck cancer


* Work commenced on four new cancer indications for Foscan (pancreas, prostate, bone metastases and skin cancer)


* Commencement of human studies on second Photodynamic Therapy product (SQN400) targeting primary hepatoma and liver metastases


* Collaboration signed with two of the world`s leading food companies for satiety product Olibra:



* General Mills in February 1999
* Bestfoods in March 2000



* Results announced today of fourth study in Olibra on 50 subjects showed increased satiety and dose response effect


* Reformulation agreements signed with several leading pharmaceutical companies


* Positive results of 300 patient study of Scotia formulation of tretinoin (for acne)


Commenting on the results, Dr. Rob Dow, Chief Executive of Scotia, said:

" There is a real sense that Scotia has achieved a great deal in 1999 in each of its four technology platform areas. We were particularly pleased to have completed the Foscan filings on schedule in the US and Europe and we have every confidence that the partnership discussions presently underway will be successfully completed in time for the launch of the product later this year. The coming year promises to be a busy one and I am confident of further good progress during 2000."

 

Enquiries:

Scotia Holdings plc

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Heather King, Investor Relations Tel: [phone]

Financial Dynamics

David Yates/ Sophie Pender-Cudlip Tel: [phone]

 

CHAIRMAN’S STATEMENT

A set of clearly delineated objectives for Scotia’s activities was created during 1998 and management teams were formed to work towards the achievement of our goals. I am pleased to report that considerable progress has been made under the strong leadership provided by Dr Rob Dow. The main features of what has emerged during 1999 are dealt with by Dr Dow in his Strategic Review and I feel sure this will prove to be of encouragement to the shareholders.

Total turnover for the 12 months to 31 December 1999 was £6.3 million (1998: £18.6 million), contributing a gross profit to operations of £1.7 million (1998: £7.8 million) The 1998 comparative results include the gross contribution before marketing expenses from our nutritional division, which was sold at the end of 1998. The loss attributable to shareholders for the full year was £33.2 million or 42.0 pence per share (1998: £18.6 million or 23.6 pence per share).

In a year in which so much has been achieved by all my colleagues, I know that they will join me in congratulating the team involved in the development of our photodynamic therapy product Foscan®. Led by Dr Chris Blackwell, all our publicly stated objectives have been met and our regulatory dossiers were lodged on time to the US and European Authorities. Furthermore, in the US, the Food and Drug Administration has awarded both Fast Track and Orphan Drug status to Foscan®. It is by fulfilling our forecasts in this way that Scotia will continue to develop a reputation for reliability.

Dr Hamish Hale, our Deputy Chairman, has informed me that he wishes to resign from the Board at the Annual General Meeting in May 2000. Hamish joined the Board in 1986 and has made a valuable and sustained contribution to the affairsof the Group during his tenure of office. We will miss his wise counsel and wish him continued health and happiness for the future.

Dr Calum MacLeod has accepted the Board’s invitation to succeed Hamish as Deputy Chairman and I look forward to working closely with him in the future.

In the course of the year our Board has been strengthened by the appointment of Mr Alan Clark, who joined us in November 1999. Alan spent most of his career with Eli Lilly & Co, before his recent retirement. He served in a number of international roles prior to his appointment, as President of Lilly’s US Operations and President of Global Marketing, reporting to the Chairman of the Board. Alan’s wide experience in the pharmaceutical industry will be invaluable, particularly at this critical period of the development of Foscan®. We are delighted that he has joined Scotia.

A further important development was the formation of a Scientific Advisory Board, made up of a group of international experts who will provide an objective review of our entire research activity.

It gives me great pleasure to refer to a most prestigious award, which has been received by Dr Bengt Herslöf from the American Oil Chemists’ Society. This is the Stephen S. Chang Award for 2000 which recognises individuals who have made a significant and distinguished contribution in basic research which has been utilised by industry in the development or improvement of products. We congratulate Bengt on this achievement.

I am also delighted to announce the appointment of Dr Michael Winther to an Adjunct Professorship in the Faculty of Graduate Studies at Dalhousie University in Halifax, Canada. This post, in the Department of Pharmacology, reflects Michael’s excellent scientific calibre and academic reputation. We offer Michael our warmest congratulations.

We have made a great deal of headway in the year to 31 December 1999 and that continues to be the case. All those who were with us in that year have given of their best at all times and my colleagues on the Board and I greatly appreciate their efforts and we thank them for all they have done.

 

CHIEF EXECUTIVE’S STATEMENT

1999 was, I believe, a year of solid and commendable performance for a streamlined Company reduced to 230 employees by the restructuring in 1998. In each of our four platform technology areas we have made valuable progress.

 

Photodynamic Therapy (PDT)

In our lead technology platform, the first and most important activity of the year was to complete the studies that would lead to a registration for Foscan®. I am happy to report that these studies met the schedule we previously announced. We feel that the documented efficacy and safety will be adequate to support approval in both the US and Europe. Files were submitted in the US in September and in Europe in October and before the end of the year we passed a major hurdle in successfully completing the 60 day review period in the US.

We stated that we would wait until we had Phase III results and a New Drug Application (NDA) file before we engaged in detailed discussions with potential licensees and these discussions are now ongoing with a goal to have a partner in place before launch. In the meantime we have taken steps to make sure that the product is ready for launch by using high quality contractors to help us with a communication strategy, scientific presentation strategy and other activities required for commercialisation.

We believe that significant commercial value will be attained by Foscan® . Our first indication for the treatment of head and neck cancer has been assigned an orphan indication and therefore will have seven years marketing exclusivity in the US. We have commenced work on four new cancer indications: pancreas, prostate, bone metastases and skin cancer. The annual incidence of these four cancers, along with our first indication of head and neck cancer, is estimated at 2.5 million patients per year.

A further major development in our photodynamic therapy platform was the commencement of human studies on a second product Bacteriochlorin (SQN400). With this compound we will pursue indications of primary hepatoma and liver metastases, which we estimate jointly have an annual incidence of 650,000 patients per year.

In the latter part of 1999 and through 2000, we will continue important basic research work with the following targets:


1. Identify new formulations of Foscan® and Bacteriochlorin, which use either reformulation technologies or antibody binding to achieve improved tissue selectivity in cancer and prolonged patent life.

2. Initiate pre-clinical research to identify a candidate for development in age-related macular degeneration.

3. Initiate pre-clinical development to identify a candidate for development in diabetic retinopathy.

4. Initiate pre-clinical development to identify a candidate for development in cardiovascular disease, particularly coronary atheroma and peripheral vascular disease.

Scotia Holdings PLC ("Scotia") is pleased to announce today that the Food and Drug Administration in the United States (FDA) has accepted for review the New Drug Application (NDA) for Scotia’s lead photodynamic product, Foscan®.

The FDA has indicated that its review of the file will be complete by July of next year. Scotia retains all the benefits of fast track status for Foscan and its recently announced orphan drug designation.

Commenting on today’s announcement, Dr Robert Dow, Chief Executive of Scotia, said:

"We are very pleased that the FDA has determined that the application contains the requisite information to permit a substantive review and that it has been accepted for filing. We are confident in the quality of our clinical data and we look forward to a successful outcome of the review process next year.

"Our negotiations with potential marketing partners are proceeding satisfactorily. We anticipate the finalisation of a marketing partnership prior to approval, enabling us to launch Foscan promptly onto the market thereafter."

 

22nd May 2000 Presentation of Pivotal Clinical Trial Results on Foscan® at ASCO

The first presentation of Scotia’s pivotal clinical trial results on Foscan was made by Dr Barry Wenig, the principal investigator of the Foscan® trial in the US centres, at the 36th Annual Meeting of ASCO (The American Society for Clinical Oncologists) in New Orleans today. This study, which looked at the palliative benefits of Foscan® mediated photodynamic therapy (Foscan®-PDT) in patients with advanced, inoperable head and neck cancer who were considered incurable, revealed impressive results.

The researchers found that not only is Foscan®-PDT (temoporfin, mTHPC) an effective palliation tool, but that a significant number of patients achieved complete or partial elimination of their tumours following the treatment.

Photodynamic therapy is a technique that uses non-thermal lasers to activate light-sensitive drugs (photosensitisers), to treat cancer and other diseases in a non-surgical, minimally invasive way. Foscan® (temoporfin, mTHPC, developed by Scotia) is a new, photosensitising agent with many advantages over earlier photosensitisers.

The aim of the study (known as the 08b study) was to determine the palliative clinical benefit of Foscan®-PDT in patients with recurrent, refractory or 2nd primary squamous cell carcinoma of the head and neck. These patients were classed as incurable as all other standard forms of treatment (surgery, radiotherapy and chemotherapy) had been exhausted.

The only options left would be to refer these patients to hospices or palliative care settings. The study also set out to measure patient survival time and the tolerability and safety of Foscan®-PDT.

Sixty-four patients between them underwent 82 Foscan-PDT treatments. Each patient received Foscan® (0.15 mg/kg IV), followed 4 days later by a single non-thermal illumination of the tumour (light dose 20 J/cm2, irradiance 100 mW/cm2, (=652 nm). An independent expert panel made up of palliative medicine specialists, oncologists, surgeons, PDT experts and radiotherapists assessed the palliative benefit.

The results revealed that 58% of patients achieved meaningful palliative benefit. However, the investigators also found that 25% of patients achieved a complete or partial reduction of their tumour. Sixteen per cent of this group achieved total tumour elimination. The mean survival time was 110 days (CI 103-116 days) and follow-up is ongoing.

Dr Wenig explained: "These results are very significant and exciting. We had not set out specifically to achieve tumour response, which appears to be very impressive. It is important to remember that we were dealing with patients who were considered incurable. In light of this, the results are remarkable."

Foscan®-PDT has significant clinical benefits in that the treatment is not associated with a deterioration in quality of life, nor with impaired function. The cosmetic results following the treatment are excellent and it is free of major toxicity and can be repeated.

The most common adverse event was pain at the treatment site and following the treatment. The pain is due to necrosis of the tumour following treatment and can be managed with standard analgesics. Mild photosensitivity reactions occurred in 10% of patients. These reactions are managed by counselling patients and giving them a simple lighting guide. The lighting guide allows the patient to gradually increase their light exposure during the period of photosensitivity, which is around 2-3 weeks.

Dr Wenig and his colleagues concluded that not only does Foscan®-PDT provide objective palliative benefit in the majority of patients with advanced cancer of the head and neck but a significant number of patients achieve complete or partial elimination of their tumours.

Dr Dow, Chief Executive of Scotia, commented: "The presentation of this study is a very important step for Foscan®-PDT as the data for this potential indication will now be peer-reviewed for the first time by the oncology community. The ASCO congress attracts thousands of abstracts and the selection of the 08b study reflects a growing interest in PDT amongst this group of clinicians."

 

Enquiries:

Scotia Holdings PLC

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Financial Dynamics         Tel: [phone]

David Yates / Sophie Pender-Cudlip 

[milan354]

Hi

Heute schon geklickt.

http://www.thehungersite.com/cgi-bin/WebObjects/HungerSite


Schönen Tag

Milan

[dergroßeM]

Sehe ich genau so

Unter Hot Stoks stehe mein Beitrag zu Scotia

[MRICH]

An alle Scoties

FDA Zulassung damit erst im Oktober ;-)

6th June 2000 Updated Foscan Database Shows Improved complete Tumour Response Rate

FDA Review Period Extended to October 2000

Scotia Holdings PLC (Scotia) announces that, following a request from the US Food and Drug Administration (FDA) for further information on patients in its pivotal Phase III study on Foscan, Scotia’s lead photodynamic therapy drug, Scotia has provided a significantly revised update of patients in the trial. Commenced in April, the update shows that the complete tumour response rate amongst patients in the trial has significantly improved from 11% in the original submission to 16% in the revised submission. To enable the FDA to review the new data, Scotia has been informed of an extension of the FDA review period from July 2000 to October 2000.

Commenting on today’s announcement, Dr Robert Dow, Chief Executive of Scotia, said:

"The goals of gaining approval for Foscan and achieving an optimal label for the product post-approval were best served by a submission of the updated database and it is pleasing to see that the update has shown a meaningful improvement in the complete tumour response rate. Whilst the submission of the revised update means that the FDA will require more time to review the file, the new data increases our confidence in the significant clinical benefit of Foscan."

 

Enquiries:

Scotia Holdings PLC

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Dr Chris Blackwell, Director of Development  Tel: [phone]

Heather King, Investor Relations Tel: [phone]

Financial Dynamics         Tel: [phone]

David Yates / Sophie Pender-Cudlip 

[MRICH]

Update zu British Medical Jornal

Scotia Holdings PLC British Medical Journal: Editor’s Comments and Authors’ Reply Regarding "Burns After Photodynamic Therapy"

Scotia Holdings PLC notes the publication of the following papers by the British Medical Journal on its bmj.com website: -

"Drug points: Burns after photodynamic therapy

Editor’s Comments

We, the BMJ, did not do as well as we would have liked in publishing this drug point.

Firstly, our policy is to ask authors reporting an adverse event associated with a drug to contact the manufacturers and ask for data on whether they have had reports on similar events. We did that, but we did not take the next step of including the data in the paper. That was a mistake, and we have taken steps to avoid it happening again.

Secondly, we should have sent the authors a copy of our standard form on competing interests and published their answers. Mr Clarke has now declared his competing interest, but he would not have been obliged to declare this competing interest under our policy because it is not a financial competing interest.

We leave readers to make up their own minds about whether Drs Taubel and Besa have competing interests that they should have declared. They are employed by a research unit that does work for pharmaceutical companies. They may thus have competing interests because if the adverse reactions resulted from how the drug was given rather than the drug itself, then questions might be raised about their suitability to work in the centre and about the services offered by the centre – both of which might have financial consequences.

The BMJ’s position on competing interests is "if in doubt declare them".

Richard Smith
Editor, BMJ

 

Drug Points: Burns after photodynamic therapy

Authors’ Reply to Dr Bryce

We were not suggesting that the true incidence of burns with Foscan is 43% - this was just the incidence in the group of patients that were referred to us. As Bryce reports, the correct figure is probably around 2%. What we were trying to highlight was that photodynamic agents can cause serious burns and that these may be more severe than conventional burns. This is an unusual occurrence and we state that this is the first group of photodynamic therapy (PDT) patients ever reported with burns after environmental light exposure.

We agree that the incidence of complications in this group was particularly high. This may well have been due to a problem during the administration of the drug. We discussed this directly with Dr Bryce at the time, during Scotia’s initial collaboration on the paper. However, this was not a pure extravasation injury. The burns only occurred on exposure to sunlight and photoactivation, two weeks after the drug was given. In addition, other body areas away from the fusion site were also affected, though less severely. This implies that the patients were generally photosensitive due to Foscan. We suspect that there were some leaking out of the drug on administration, leading to high tissue concentrations around the infusion site. On photoactivation the most severe reaction occurred here, resulting in the worst burns.

Irrespective of whether there was some problem with the administration of the drug or not, these patients suffered serious burns and we believe that the causative agent was Foscan. This is a rare but serious complication that the medical community needs to be aware of. It is important for the clinicians using photosensitisers to know that complications can occur and for burns surgeons to know that PDT induced burns may behave differently from conventional thermal injuries.

Shehan Hettiaratchy
Specialist Registrar in Plastic and Reconstructive Surgery
West Midlands Regional Burns Unit, Selly Oak
University Hospital, Birmingham B29 6JD

John Clarke
Consultant Plastic and Reconstructive Surgeon
Regional Burns Unit, Chelsea and Westminster Hospital
London, SW10 9NH

Competing Interest: - JC provided medical reports on the injuries and the initial management of the six patients. No fee was charged."

 

Enquiries:

Scotia Holdings PLC

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Heather King, Investor Relations Tel: [phone]

Financial Dynamics         Tel: [phone]

David Yates / Sophie Pender-Cudlip 

[MRICH]

Anbei ein sehr gutes Board über Scotia Holdings PLC.

Schaut mal rein und informiert euch über Scotia.

http://quote.fool.co.uk/summary.asp?Symbols=soh

CU

[MRICH]

Mehr Infos über Scotia unter:

http://quote.fool.co.uk/summary.asp?Symbols=soh

Geht rein und informiert euch.

CU

[MRICH]

Keine Interessenten für Scotia?!

Macht euch mal schlau.
CU

[MRICH]

Scotia heute in Frankfurt für 2.10

Immer noch super Einstiegskurse, wenn man bedenkt wie alleine die Meldung hinsichtlich "Bestfood" im Frühjahr den Kurs bewegt hat.

Also nutzt die guten Kurse und investiert in Scotia.

CU

[MRICH]

AFX (UK): SCOTIA HOLDINGS SAYS `IMPRESSIVE` RESULTS FROM FOSCAN FOR HEAD, NECK CANCER
AFX (UK), May 22, 2000, 173 words

Scotia Holdings PLC said its 08b study revealed "impressive results" for its Foscan mediated photodynamic therapy (Foscan-PDT).

The results found 58 pct of patients with advanced, inoperable head and neck cancer who were considered incurableachieved meaningful palliative benefit and 25 pct of patients achieved a complete or partial reduction of their tumour. Sixteen per cent of the latter group achieved total tumour elimination.

The therapy uses non-thermal lasers to activate light-sensitive drugs (photosensitisers), to treat cancer and other diseases in a non-surgical, minimally invasive way, it said.

Foscan (temoporfin, mTHPC, developed by Scotia) is a new, photosensitising agent with many advantages over earlier photosensitisers.

Principal investigator Dr Barry Wenig said the results are "very significant and exciting and that the team had not set out specifically to achieve tumour response.

He said the results are remarkable considering the patients were considered incurable.

--------------------------------------------------------------------- Scotia said Foscan-PDT has significant clinical benefits as it is not associated with a deterioration in quality of life, nor with impaired function.

[MRICH]

Hi Scoties oder die die es noch werden wollen!

Kurs heute von Scotia in Frankfurt 2,30 :-)

CU

[MRICH]

Presentation of Pivotal Clinical Trial Results on Foscan® at ASCO

The first presentation of Scotia’s pivotal clinical trial results on Foscan was made by Dr Barry Wenig, the principal investigator of the Foscan® trial in the US centres, at the 36th Annual Meeting of ASCO (The American Society for Clinical Oncologists) in New Orleans today. This study, which looked at the palliative benefits of Foscan® mediated photodynamic therapy (Foscan®-PDT) in patients with advanced, inoperable head and neck cancer who were considered incurable, revealed impressive results.

The researchers found that not only is Foscan®-PDT (temoporfin, mTHPC) an effective palliation tool, but that a significant number of patients achieved complete or partial elimination of their tumours following the treatment.

Photodynamic therapy is a technique that uses non-thermal lasers to activate light-sensitive drugs (photosensitisers), to treat cancer and other diseases in a non-surgical, minimally invasive way. Foscan® (temoporfin, mTHPC, developed by Scotia) is a new, photosensitising agent with many advantages over earlier photosensitisers.

The aim of the study (known as the 08b study) was to determine the palliative clinical benefit of Foscan®-PDT in patients with recurrent, refractory or 2nd primary squamous cell carcinoma of the head and neck. These patients were classed as incurable as all other standard forms of treatment (surgery, radiotherapy and chemotherapy) had been exhausted.

The only options left would be to refer these patients to hospices or palliative care settings. The study also set out to measure patient survival time and the tolerability and safety of Foscan®-PDT.

Sixty-four patients between them underwent 82 Foscan-PDT treatments. Each patient received Foscan® (0.15 mg/kg IV), followed 4 days later by a single non-thermal illumination of the tumour (light dose 20 J/cm2, irradiance 100 mW/cm2, (=652 nm). An independent expert panel made up of palliative medicine specialists, oncologists, surgeons, PDT experts and radiotherapists assessed the palliative benefit.

The results revealed that 58% of patients achieved meaningful palliative benefit. However, the investigators also found that 25% of patients achieved a complete or partial reduction of their tumour. Sixteen per cent of this group achieved total tumour elimination. The mean survival time was 110 days (CI 103-116 days) and follow-up is ongoing.

Dr Wenig explained: "These results are very significant and exciting. We had not set out specifically to achieve tumour response, which appears to be very impressive. It is important to remember that we were dealing with patients who were considered incurable. In light of this, the results are remarkable."

Foscan®-PDT has significant clinical benefits in that the treatment is not associated with a deterioration in quality of life, nor with impaired function. The cosmetic results following the treatment are excellent and it is free of major toxicity and can be repeated.

The most common adverse event was pain at the treatment site and following the treatment. The pain is due to necrosis of the tumour following treatment and can be managed with standard analgesics. Mild photosensitivity reactions occurred in 10% of patients. These reactions are managed by counselling patients and giving them a simple lighting guide. The lighting guide allows the patient to gradually increase their light exposure during the period of photosensitivity, which is around 2-3 weeks.

Dr Wenig and his colleagues concluded that not only does Foscan®-PDT provide objective palliative benefit in the majority of patients with advanced cancer of the head and neck but a significant number of patients achieve complete or partial elimination of their tumours.

Dr Dow, Chief Executive of Scotia, commented: "The presentation of this study is a very important step for Foscan®-PDT as the data for this potential indication will now be peer-reviewed for the first time by the oncology community. The ASCO congress attracts thousands of abstracts and the selection of the 08b study reflects a growing interest in PDT amongst this group of clinicians."

[MRICH]

21st June 2000
Scotia Holdings PLC

Response to Letter in British Medical Journal

Scotia Holdings PLC ("Scotia") notes the publication of a letter on the British Medical Journal website, bmj.com, by two of the authors of an article headed "Drug points, burns after photodynamic therapy" (Hettiaratchy et al) originally published in the BMJ edition of 6 May 2000. This letter suggests that a contributing factor to the skin burns seen in six of fourteen men treated with Foscan may have resulted from the drug being given in a new solvent formulation.

Originally formulated as a powder that had to be reconstituted with water prior to its administration, the addition of a solvent to Foscan has enabled the drug to be administered as a ready-mixed fluid to patients, resulting in greater convenience for the administering doctor.

In clinical studies around the world, other than in the study conducted by the Charterhouse Clinical Research Unit and reported by Hettiaratchy et al, 100 patients have received the new formulation and no patients have suffered injuries as described in the Hettiaratchy et al study.

The Directors of Scotia believe that it is reasonable to conclude that, with an incidence of 0% in 100 patients so far (excluding the Charterhouse study), the new formulation is unlikely to be associated with a true incidence of adverse events that is different from the overall incidence of 2.3% (mild to moderate burns) in 957 volunteers and patients recorded to date.

 

Enquiries:

Scotia Holdings PLC

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Heather King, Investor Relations Tel: [phone]

Financial Dynamics         Tel: [phone]

David Yates

[MRICH]

Neuigkeiten von Scotia - September/Oktober wird der Kurs explodieren :-)

2nd Aug 2000
Scotia Pharmaceuticals announces promising results for Foscan®, , a potential new treatment for head and neck cancer patients

The latest trial results on Foscan® mediated photodynamic therapy (Foscan®, temoporfin, mTHPC) potentially indicate that it may be an important advance in the treatment of primary, secondary and advanced head and neck cancer. Results from three trials on over 250 patients were presented this week to 2,500 delegates attending the 5th International Conference on Head and Neck Cancer in San Francisco.

Photodynamic therapy is a non-surgical, minimally invasive technique that uses light (usually from a laser) to activate light-sensitive drugs (photosensitisers) in the treatment of cancer and other diseases. Foscan®, developed by Scotia Pharmaceuticals, is a second generation photosensitising agent.

The first study presented by Mr Colin Hopper, on behalf of the Foscan®-PDT 01 Study Group, observed the response to Foscan®-PDT in 115 patients with primary head and neck cancers and whose tumors were Tis, T1 or T2 (up to 2.5cms in diameter, 0.5 cm deep).

Analysis of the data reveals that there was complete elimination of the tumor in 88% of patients deemed evaluable at 12 weeks. This study is ongoing with subjects being followed for 2 years. An analysis of the study results to date suggests that this response to treatment was durable, with a complete response rate at one year of 86% (79% at two years). The most common adverse event was pain at the treatment site which can normally be managed with non opiate analgesics.

"These results suggest that Foscan®-PDT has the potential to become a first-line treatment in primary head and neck cancers. It appears to be an effective procedure with minimal morbidity and good cosmetic and functional results " said study author, Mr Colin Hopper, Consultant Oral and Maxillofacial Surgeon, London.

The second study, presented by Dr Merrill Biel on behalf of the Foscan®-PDT 03 and 08 Study Groups, investigated Foscan®-PDT in 96 patients with superficial recurrent or second primary oral cancers up to 4cm diameter (0.5cm deep). Treatment options in this group are limited as it can be difficult to repeat surgery at a previously treated site, and radiation is normally only delivered once to any particular anatomical site. Response to treatment was measured at 12 weeks. This study is ongoing with subjects being followed up for 2 years.

Interim results show that 55% of patients deemed evaluable had a complete tumor response post treatment and a further 31% of evaluable patients had a partial tumor response. At one year 78% of complete responses were still clear of tumor. Follow up is still ongoing. Survival rate for all patients at one year was 65% (49% at two years). The most common adverse event was pain at the treatment site which can normally be managed with non opiate analgesics.

Commenting on the results, study author Dr Merrill Biel, Head and Neck Oncologic Surgeon, Minneapolis, said "The complete response rates achieved with Foscan®-PDT in this initial study appear encouraging. At least 30% of patients previously treated will develop further recurrences or new primary tumors and Foscan®-PDT may allow retreatment of previously treated sites."

The aim of the third study presented by Dr Anil D`Cruz, on behalf of the Foscan®-PDT 08b Study Group, was to determine the palliative benefit of Foscan®-PDT in 64 patients with advanced head and neck cancer, considered incurable by surgery or radiotherapy. The study showed that using a two point improvement or normalization in the relevant prospectively defined University of Washington symptom scale to define success, 33% of the 64 patients achieved successful palliation of their prospectively defined symptom or complication. Fifty-three percent of patients achieved meaningful palliative clinical benefit as determined by an Independent Assessment Board. The Independent Assessment Board comprised of experts in palliative medicine, specialists, oncologists, surgeons, PDT experts and radiotherapists, who assessed the palliative benefit for each patient. The benefits included reduction in pain, improvement in swallowing, speech or function. Censored median survival time was 226 days. The most common adverse event was pain at the injection site which is transient and does not require treatment.

An additional finding was that 17% of patients achieved complete local clearance and in total 28% of patients achieved a complete or partial tumor response (WHO tumor response).

The principal investigator, Dr Anil D`Cruz, Professor and Surgeon, Tata Memorial Hospital, India said, "The patients entered into this study were considered incurable by conventional treatments, there was no further hope for them. To achieve complete tumor response in 17% of patients treated is exciting. Foscan appears to offer new hope to patients with advanced disease."

The side effects of Foscan®-PDT mainly relate to pain associated with PDT induced necrosis at the tumor site. Mild photosensitivity reactions occurred in 10% of patients.

Commenting on the three studies, Dr Merrill Biel said, "The results from the three studies indicate that Foscan®-PDT could serve as a potentially effective and well tolerated treatment in all stages of squamous cell carcinoma of the head and neck. Foscan®-PDT is a simple technique with low toxicity. It is well tolerated and appears to produce excellent cosmetic and functional results. In addition, Foscan®-PDT can be repeated at the same site and does not preclude the use of other treatments if required."

Notes to Editors

1. Populations: patients evaluable for analysis are those who received adequate drug and light and for whom tumor assessment was possible. This excludes early withdrawals and deaths not related to the tumor under treatment.

2. To date, over 1,000 patients have been treated with Foscan®-PDT in various multi-center trials and individual investigator sponsored, named patient and compassionate use treatments. Foscan® has also been investigated for the treatment of a variety of other types of cancers including: stomach; ovary; oesophagus; bronchi; brain; pleura; chest; prostate; pancreas, bile duct and skin.

Scotia Pharmaceuticals submitted an application to the FDA and the EMEA in September 1999 for a licence for the use of Foscan® in the treatment of head and neck cancers.

[MRICH]

Scotia Holdings reports `promising` results for Foscan

LONDON (AFX) - Scotia Holdings PLC said its Scotia Pharmaceuticals unit`s
Phase II trial results this week on Foscan, a candidate for the treatment of
primary, secondary and advanced head and neck cancer, were `promising`.
In the results of trials on 250 patients, the company said that Foscan-PDT
has the potential to become a first-line treatment in primary head and neck
cancers.
Scotia also said one potential advantage of Foscan-PDT treatment is that it
may be repeated at the same site and does not preclude the use of other
treatments if required.
The Foscan treatment uses photodynamic therapy to activate light-sensitive
drugs in patients where required, for cancer and other diseases.
dd
For more information and to contact AFX: www.afxnews.com and www.afxpress.com

[MRICH]

http://www.uk-wire.com/articles/200008020700538391O.html

http://quote.fool.co.uk/summary.asp?Symbols=soh

;-))

[Mr.Keating]

Scheint ja ein tolles Unternehmen zu sein.
Ich habe mal die Bitte, dass ihr
mir die Pipeline bzw. News zu
Medikamenten auf Deutsch postet.

Wie sehen die Umsatzzahlen aus ????
Wann sollte amn einsteigen ????

Hoffe, dass mich eure postings vollends
davon überzeugen in diese Firma zu
investieren.

MfG Mr.Keating

[MRICH]

ACTIVITIES:  Development and marketing of pharmaceutical and dietary products
STATUS:  Full.
INDEX:  FTSE SmallCap, techMARK , Frankfurt, Berlin
SECTOR:  Pharmaceuticals
HEAD OFFICE:  Scotia House, Castle Business Park, Stirling, Scotland, FK9 4TZ. Tel: [phone]. Fax: [phone]
REGISTRARS:  Computershare Services, Registrar`s Dept, PO Box 435, Owen House, 8 Bankhead Crossway North, Edinburgh, Computershare Services. Tel: [phone]. Fax: [phone].
ANNCMNTS:  Int - early Sep; Final - late Mar.
AGM:  late May.
INTERIM:  (12 Oct 99) 1/2 yr to 30 Jun 99. T/O £3.17m (£10.2m). Pre tax loss £14.6m (£11.1m). Loss per share 18.4p (14.2p).
NOTES:  (Figures in accordance with FRS3)
More Information

 
Pharmaceuticals
· Alphabetical Industry Listing
· Industry Listing By Capitalisation

Year ended 31 December    1997  1998  1999   
------------------------------------------------------------------------
Turnover Mill. £ 18.90 18.60 6.34
Pre tax profit Mill. £ -20.70 -18.60 -33.20
Norm earn per share p -26.40 -34.60 -38.60
FRS3 earn per share p -26.40 -23.40 -41.70
Div per share p - - -
------------------------------------------------------------------------
Intangibles Mill. £ - - -
Fixed assets Mill. £ 18.20 16.40 17.00
Fixed investments Mill. £ 0.01 0.01 0.01
------------------------------------------------------------------------
Stocks Mill. £ 11.50 6.08 4.06
Debtors Mill. £ 5.46 6.62 2.40
Cash, securities Mill. £ 18.20 52.70 21.80
------------------------------------------------------------------------
Creditors short Mill. £ 13.30 10.60 9.82
Creditors long Mill. £ 11.60 60.40 57.90
Prefs, minorities Mill. £ - - -
Ord cap, reserves Mill. £ 28.50 10.80 -22.40
Mkt capitalisation Mill. £ 207.00 49.40 105.00

[MRICH]

Alles wichtige unter

http://uk.biz.yahoo.com/z/s/soh.l.html

[MRICH]

nochmal pushen ;-)

[stepsahead]

Hast Glück gehabt, der Umsatz in Berlin und Frankfurt betrug ca.
2200 Stück in den letzten 3 Tagen. Ich hoffe für Dich mit ab Herbst.
Die Idee ist Klasse, aber die Vermarktung des Produkts eine andere
Dimension für so eine holding.
greetings

[Mr.Keating]

Laßt uns diesen Thread doch bitte weiter
aufrecht erhalten, denn nach euren
Einschätzungen geht die brisante Zeit
der Entdeckung von Scotia Holdings PLC
durch andere Anleger, mit der Zulassung von
Foscan im Herbst erst richtig los.

Also bitte postet neue interessante News und Meinungen
zu diesem Wert um uns bis zum rasanten Ausbruch ( hoffentlich )
bei Laune zu halten.

MfG Mr.Keating

[stepsahead]

Is ja gut,
ich habe die letzten Tage auch Aktien gekauft und konnte damit
den Kurs stützen :-)))
Finde die story hoch interessant und brisant und hoffe nur auf eine
gute Vermarktung dieses Produkts. Meines erachtens wäre es wichtig
eine Kooperation mit einer großen holding im Pharmabereich einzu-
gehen, um deren Strukturen zum Vertrieb ausnutzen zu können.
greetings

[Der Bär]

Heute in London fast 600000 Aktien umsatz (bis jetzt) und + 4 %.
In Deutschland tote Hose. Aber vielleicht geht Scotia auch irgendwann mal an eine amerikanische Börse, dann gehts rund.

Schaun mer mal
Der Bär

[Mr.Keating]

Wann gehts denn nun los mit Foscan ???

Wie sieht die Zukunft aus betreffs Pipeline
und Kooperationen ???
Sollte man sie für 1 Jahr im Depot lassen ???

[MRICH]

Mit der hoffentlich im Oktober erfolgenden Zulassung seitens der FDA und bis Ende des Jahres durch die europäische Zulassungsbehörde, wird es erst richtig interessant.

Hoffentlich kommen nach der Zulassung ein paar positive Stellungnahmen bezüglich Marketingpartner. Derzeit werden sich potentielle Partner wohl noch zurück halten. Aber sobald die Zulassung da ist müssten die News kommen :-)).

[MRICH]

Hallo Scoties der Interim Report von Scotia Holdings :-))

7th Sept 2000
Scotia Holdings PLC Interim Results for the Six Months to 30 June 2000

Scotia Holdings PLC ("Scotia") announces its interim results for the six months ended 30 June 2000.

Highlights

Significantly updated Foscan® database submitted to the USA Food and Drug Administration (FDA) in June, showing an improved complete tumour response rate
Widespread peer review of updated Foscan® data at a series of international medical symposia, including long term data showing the durability of the tumour response with Foscan®
Clinical development of Foscan® initiated in four additional indications of cancers of the pancreas, prostate, bone and skin
Clinical development programmes for Scotia’s next generation PDT product, bacteriochlorin, initiated in the treatment of primary liver cancer and metastatic liver cancer
Exclusive agreement signed with Techniclone Corporation to expand Scotia’s intellectual property rights in PDT
Agreement signed with the international food company, Bestfoods, to evaluate Olibra® in its Knorr® range of products
First human study completed on Scotia’s pharmaceutical satiety product, SX013
Positive results from the comparator trial on Scotia’s formulation of tretinoin for acne, showing improved tolerability whilst maintaining efficacy. Discussions with potential licensing partners are ongoing
Lipid genomic research has led to patents being filed which relate to new methods of screening drugs and the identification of novel drug targets
Completion of an institutional placing in January 2000 to raise £11.2 million to provide additional working capital to maintain momentum on key projects
Dr Robert Dow, Chief Executive of Scotia, said:

"During the course of 2000, Scotia has taken a number of important steps to enhance the Company’s long term prospects. In particular, the updated Foscan data continues to encourage us and we await with interest the outcome of our filing with the FDA which is due shortly. Scotia’s many other projects, each of which we believe is capable of creating substantial value for our shareholders, also continue to make good progress."

Full text of interim results

Enquiries:

Scotia Holdings PLC

Dr Rob Dow, Chief Executive Officer Tel: [phone]

Financial Dynamics Tel: [phone]

[Der Bär]

Das enorme Potential hat heute einen starken Dämpfer erhalten. Keine Zulassung von Foscan in USA. Der Kurs hat sich fast halbiert.
Na Klasse !!!!

[puhvogel]

Au weia, das nächste "no" der FDA zu einer Krebstherapie

26th Sep 2000
FDA concludes initial review of
Foscan® NDA

Scotia Holdings PLC ("Scotia") announces
today that it has received notification from
the US Food and Drug Administration (FDA)
that its application for Foscan® in Head and
Neck cancer is not approvable at this time.

Dr Robert Dow, Chief Executive of Scotia,
said:

"The Company plans to work diligently with
the FDA to move forward with the regulatory
review of this product. Over the coming
weeks we will establish through written and
face-to-face interaction with the FDA what
issues remain to be resolved to obtain
approval. We continue to believe strongly in
the clinical utility of Foscan® in Head and
Neck cancer and will continue to update our
shareholders as we identify the appropriate
actions for the future."

http://www.scotia-holdings.com

[puhvogel]

He Bär, Du warst ja 7 Sekunden schneller.
Man sollte sich diesen Fall und den von CLPA mal näher ansehen. Vielleicht gab es Warnzeichen?
Der Puhvogel

[MRICH]

Ganz kalt erwischt. Knie wackeln und mein Gesicht ist ganz bleich.

Die Frage lautet nun: Nachkaufen, Halten oder Raus?

Ich plediere für Nachkaufen oder Halten.

Foscan wäre nicht das erste Produkt das zwei Anläufe benötigt um
eine FDA Clearance zu erhalten.


Also dickes Kopfkissen und weg legen.

[stepsahead]

Nachkaufen! Das Produkt ist Klasse, immer Firmen tauchen mit
PDT Therapien auf.
Ein Problem gibt´s aber, laut Analyst Woolf von ABN Amro hat
scotia nur noch cash bis 3.2001