Access Pharma: Bio-/Nanotech vor FDA-Zulassung - 500 Beiträge pro Seite

[Neoe]

Aufgrund der Kursgewinne der letzten Tage steigt das Interesse an Access Pharma, deswegen also die Eröffnung eines Threads

Zunächst nur das Wichtigste, morgen mehr:

Allgemein:
OraDisc ist eine Technologie zur besseren Verabreichung von Medikamenten (und anderer Dinge) im Mundbereich und löst die Schwierigkeit, die zum Beispiel bei Anwendung von Salben und Gels im Mundbereich entstehen.

1. OraDiscA steht direkt vor der Zulassung (<60 Tage) )->
Alleinstellungsmerkmal-> Marktpotential 100 Millionen
Dollar->Behandlung von entzündenden Mundgeschwüren

2. OraDiscB-E bereits in Planung->Milliardenmärkte (zum
Beispiel Atemerfrischer mit Langzeitwirkung) in Aussicht
->ein Abkommen mit Wyeth (NYSE:WYE) für OraDiscB
steht, andere stehen unmittelbar vor dem Abschluss

3. Die Produkte nach OraDiscA brauchen keine klinischen
Studien mehr, sofern das durch OraDisc verabreichte
Produkt kein neues, nicht zugelassenes Medikament ist

4. ACCESS PHARMA hat darüber hinaus Medikamente in der
Pipeline, die sich bereits in Phase II oder kurz vor
Phase III befinden, die jeweils ein Potential von
500 Millionen bis 2 Milliarden Dollar haben (First Line
Therapy für diverse Krebsarten und Mucositis)


Zu OraDisc und der Pipeline gibt es noch vieles zu erzählen, dass die Geschichte noch bedeutend aussichtsreicher erscheinen lässt, als so schon...


Der Chart:

[Neoe]

Natürlich nicht zu vergessen die Drug-Delivery-Plattformen. Hier gibt es gleich mehrere Varianten. Im Nanotech-Bereich hat man schon eine große Kooperation mit einem unbenannten Partner. Für eine weiter Methode/Plattform, die die orale Verabreichung von Antikörpern ermöglicht, wurde Celltech gewonnen und ein weiterer, großer (aber unbenannter Partner).

Also, die Frage ist, wo hat ACCESS kein Ass im Ärmel ?

[EinKoelner]

ACCESS hat kein As im Ärmel weil vernünftige Leute Mologen kaufen

[Boersenkrieger]

naja weiss nicht... zu viele unbekannte

[Neoe]

@einkoelner:

Was ich hab brauch ich nicht kaufen. Trotzdem: ACCESS favorisiere ich gegenüber Mologen trotzdem klar.

[BrauchGeld]

Hi Leute

Ist zwar nicht von heute aber dennoch interessant .

President`s 2004 Letter to Shareholders
--------------------------------------------------------------------------------


During the past 12 months, Access has continued to make significant progress implementing our business plan. The plan was designed to build a fundamentally sound company capable of generating revenues from lower-risk opportunities to fund our exciting oncology and drug delivery initiatives. Progress has been achieved in several critical areas including the advancement of our clinical development candidates and the generation of data supporting our preclinical initiatives. Significant progress has been made in the implementation of our partnership strategy. Importantly, during 2003 the investment community commenced to recognize the value of our scientific programs and the disparity of the company`s valuation relative to our peer group. We are optimistic that with a further improvement in the investment environment for the healthcare sector and the execution of our strategic plan, the market capitalization of the company will continue to increase and our technology value will be reflected in our share price.

The achievements during 2003 validate our business model and clearly demonstrate that it is possible to cost-effectively develop new products, and file for regulatory approval, with a small focused team of dedicated employees. The filing of a New Drug Application for OraDiscTM A with the FDA, and having the filing accepted, is a clear confirmation of this approach, as the technology was invented and developed by the company, and five clinical studies were conducted. The preparation of the NDA was completed entirely in-house. Our facility, and that of our contract manufacturer, was prepared for the FDA inspection which accompanies the submission of an NDA.

During the past year, our first collaboration with a major pharmaceutical company was executed, a licensing agreement for an over-the-counter product application of our OraDiscTM technology with Wyeth Consumer Healthcare. Partnerships such as this not only generate revenues for the company but also provide an external validation of our technology. This is a first step in the implementation of our partnership strategy, which is a cornerstone to our business model.

BUSINESS STRATEGY

When Access was formed through the merger of two entities in January 1996, it was our stated objective to build a company with a diverse product portfolio, balanced in terms of timing and development risk, and not to be reliant on one product or technology for the ultimate success of the company. Through the development of the nearer-term, lower-development risk opportunities we have commenced the development of a fundamentally sound business capable of generating profitability and providing the funding for our major initiatives in oncology and polymer drug delivery. I believe that we are now well positioned to benefit from this business strategy as we project having four marketed products generating product revenues within the next 12 months.

Additionally, several of our product development candidates and preclinical technologies have advanced to the point where revenues could be generated from licensing, research collaborations and product development opportunities.

I believe that our portfolio is well balanced in terms of developed products, clinical candidates and preclinical technologies, which enables us with our focused organization to effectively advance our priority initiatives. Our major product opportunities are receiving the necessary management attention, scientific support and research funding to realize the value of these technologies

2003 PERFORMANCE

During the past 12 months, there were significant commercial, development and scientific achievements, which included:

Filing the OraDiscTM A NDA and having the filing accepted by the FDA.
Execution of a licensing agreement with Wyeth Consumer Healthcare, a division of Wyeth, granting the North American rights, with an option to extend the agreement to a worldwide license, to market an OTC product utilizing our OraDiscTM technology.
Execution of two collaborative research agreements to evaluate our preclinical technologies.
Continued advancement of our polymer platinate program including the clinical advancement of AP5346 and the development of significant preclinical data supporting the program.
Expansion of our OraDiscTM technology with additional development candidates and further technology improvement.
Substantial completion of the development and manufacturing scale-up of OraDiscTM B containing benzocaine.
Significant expansion and advancement of our corporate partnering discussions.
The issuance of two US patents, one covering our polymer platinate technology and the other our OraDiscTM technology.
Significant expansion of the preclinical data base supporting our nanoparticle aggregate technology, vitamin mediated oral delivery and targeted polymer therapeutics program in cancer.
Additionally, Zindaclin® was launched by our partners in further markets including France and Germany, and the licensing of Zindaclin® was expanded to cover in excess of 30 markets worldwide. We established a new contract manufacturer for
Aphthasol® and the necessary production was completed to achieve both US and European approval for this supplier.

During 2003 we commenced a more aggressive program to gain institutional investor awareness and recognition in the financial community. I believe that we are now realizing the benefits of this program and we intend to continue this investor relations program to gain additional visibility and expand our shareholder base.

In February 2004, we completed a $9.7 million private placement which was placed with approximately 12 institutions. While it would have been possible to raise significantly greater equity, given our anticipated cash flow, this funding is expected to provide us the necessary resources to aggressively advance our product developments, while limiting the dilution of existing shareholders.


DRUG DELIVERY OPPORTUNITY

The market for products utilizing drug delivery systems is growing significantly, in part due to the need of pharmaceutical companies to extend intellectual property protection of their current products by utilizing proprietary drug delivery systems and the increasing number of therapeutics requiring drug delivery solutions to maximize the products` effectiveness. The competitive advantages offered with all four of our drug delivery platforms place us in an advantageous position to capitalize on this market trend. The delivery solutions offered by our technologies address several major needs of the industry: targeted drug delivery, oral delivery of products currently only available by injection and the stabilization and delivery of proteins and peptides. Our commercially-viable broadly-based delivery platforms offer us the opportunity to position the Company as the "Drug Delivery Solution Company."

GROWTH OPPORTUNITIES

We are focused on four core technology platforms to drive our future growth: Targeted Polymer Therapeutics, Vitamin Mediated Oral Delivery, Nanoparticle Aggregates and OraDiscTM. While we have four core technology platforms, these technologies are all based on polymer drug delivery, which enables us to leverage our extensive expertise in this field. We believe these advanced drug delivery technologies can provide the Company with a flow of product development candidates over the next five years and beyond.


We believe that OraDiscTM provides Access with the opportunity to develop over-the-counter products to generate near-term licensing and product sales revenues. The licensing agreement with Wyeth Consumer Healthcare is an important validation of this technology and the potential to develop other over-the-counter products. In addition to the near-term potential this technology affords, there exist significant opportunities to develop prescription products utilizing the technology as a buccal delivery device. OraDiscTM is the major component of our near-term objective to establish a sound revenue base for the company. Third party interest would indicate that there is significant potential in the near-term to develop numerous products in multiple therapeutic areas to achieve this objective.


The polymer platinate program is our most exciting and advanced development utilizing our targeted polymer therapeutics technology. In the past 12 months, not only have we advanced the clinical development of AP5280 and AP5346, we have greatly enhanced the preclinical program supporting this project. Recently presented preclinical data on platinum accumulation in tumors and the formation of Pt-tumor DNA complexes offers strong confirmation in an animal model that our polymer technology can deliver significantly more drug to the target for tumor inhibition. Development work continues to optimize the benefits of targeted polymer therapeutics including utilizing vitamins to target tumors, and to identify the polymer delivery vehicle which will maximize the therapeutic ratio - the balance between effectiveness and toxicity. We have recently developed some exciting data in this area and additional work is ongoing to establish the necessary intellectual property position prior to disclosing these results.

There is a high level of excitement within the Company regarding our nanoparticle aggregate technology and the potential benefits this technology offers for protein and peptide delivery. Protein and peptide therapeutics are a rapidly expanding area within the pharmaceutical industry that requires a drug delivery approach for maximum effectiveness and patient convenience. The ability to develop sustained delivery forms for products which currently require frequent injections is considered a major opportunity. Extensive preclinical studies have been conducted internally to show that extended delivery and response to the delivered macromolecule can be achieved over periods in excess of 70 days. Access has established a collaboration with a major drug delivery company to evaluate our technology for the delivery of macromolecules and we intend to establish further collaborations in this area. We believe that our nanoparticle aggregate technology represents the most versatile biocompatible material currently available with numerous competitive advantages compared to competing technologies.

During 2003 we formed our first collaboration involving our vitamin mediated oral drug delivery technology with Celltech, a major company in the area of protein therapeutics. The ability to deliver proteins and peptides orally is considered the gold standard in drug delivery. The collaboration with Celltech will evaluate the ability of our technology to deliver monoclonal antibodies or fragments of antibodies. During 2003 further preclinical work was conducted which provides additional support for this technology, confirming the active transport of drug from the gut into the blood stream and the achievement of the desired therapeutic effect. In 2004 we plan to establish additional research collaborations with our vitamin mediated oral drug delivery technology to evaluate the delivery of numerous compounds.

SCIENTIFIC ORGANIZATION

The benefits of the expansion of our scientific organization to include a biological capability were clearly evident in 2003. Our Australian subsidiary with its biological capability, both in vitro and animal, has enabled us to not only more cost effectively and rapidly develop our technologies but also provide additional scientific support for the technologies. The rapid development of our nanoparticle aggregate technology is a clear demonstration of the advantages afforded by having this biological capability.


As our company matures, product candidates advance towards the market, and additional strategic partnerships are formed, there will be an increasing need to expand our project management and product procurement abilities. Further, in order to accelerate the development of our nanoparticle aggregate technology, additional resources will be required. These areas will be addressed in 2004, however, it is anticipated that our head count will not significantly exceed 40 during the upcoming 12 months.

COLLABORATIONS

The successful advancement of our development programs and product candidates has placed us in a favorable position to significantly expand our partnership programs. An advantage of our business strategy, the development of a broadly-based technology portfolio, is that multiple licensing opportunities are possible. In addition, as Access is developing several drug delivery technologies numerous products are expected to be developed utilizing these technologies.

Consequently, the possibility exists to enter multiple licensing agreements for all four of our technology platforms. Currently, multiple discussions are ongoing aimed at forming collaborations for product development using all four technologies.

2004 OUTLOOK

During the upcoming 12 months our plans include the achievement of numerous commercial and development milestones, including:

Approval of OraDiscTM A in both the US and Europe.
Additional license agreements for a number of our products and technologies.
Research collaborations involving our preclinical technologies
OTC product development agreements.
Initiation of the next clinical development phase for both polymer platinate and mucositis technology.
Product launches in both the US and Europe for existing approved products and the OraDiscTM products.
During 2004, we plan to advance several product development candidates towards clinical development utilizing our drug delivery technologies. It is anticipated that this will be achieved through co-development activities with partners as well as Access` internal product development candidates.

In closing, at our inception our long range objective was to become a leader in the drug delivery segment of the industry. We believe that we have now accumulated the technologies through licensing, acquisition and internal developments to achieve our objectives. Our strengths include the dedication of our employees, the quality of our science and the strength and depth of our development pipeline.

Our achievements would not have been possible without the support of our shareholders, the leadership of the Board of Directors and the dedication of our senior management and employees, all of whom I thank.

[Neoe]

Der wahre Wert des Unternehmens liegt hier. Da wird es Roche und Co. angst und bange werden:


Cancer is the second-leading cause of death in the United States with more than 8 million people having cancer and another 1.4 million new cases diagnosed each year. Chemotherapy, surgery and radiation are the major components in the clinical management of cancer patients. Chemotherapy is increasingly used as an adjunct to radiation and surgery to improve efficacy, and is used as the primary therapy for some solid tumors and metastases. The current optimal strategy for chemotherapy involves exposing patients to the most intensive cytotoxic regimens they can tolerate. Clinicians attempt to design a combination of drugs, dosing schedule and method of administration to increase the probability that cancerous cells will be destroyed while minimizing the harm to healthy cells.
Most current chemotherapy agents have significant limitations. Certain cancers are inherently unresponsive to chemotherapeutic agents. While other cancers initially respond, subgroups of cancer cells acquire resistance to the drug during the course of therapy, with the resistant cells surviving and resulting in relapse. Another limitation of current anti-cancer drugs is that serious toxicity, including bone marrow suppression and organ failure, can prevent their administration in curative doses.

Polymer platinate is a proprietary technology which the Company believes has the potential to provide a series of new chemotherapeutic agents which will have significantly superior efficacy in treating numerous cancers compared to existing platinum compounds. Platinum compounds are one of the largest selling categories of chemotherapeutic agents with annual sales in excess of $800 million.

The drug delivery goal of polymer platinate is to elevate drug delivered to the tumor and minimize the amount of drug affecting normal organs in the body. The polymer platinate approach seeks to achieve this goal by attaching small platinum molecules to a larger polymer. This takes advantage of the fact that the cells lining the walls of blood vessels that feed tumors are usually hyperpermeable, allowing the large polymer platinate molecules to enter the tumor in preference to other tissue, which does not have hyperpermeable blood vessels. In addition, the drainage system of tumors is not well developed, so once delivered, the drug gets trapped in the tumor. This dual effect is called enhanced permeability and retention (EPR). The small polymer molecules are released within the tumor to provide the chemotherapeutic effect.

In addition, the polymer is designed to shield the platinum from interactions with normal cells while the drug is in circulation, thereby reducing toxicity. It is believed that polymer platinate molecules bypass known membrane-associated mechanisms for development of tumor resistance, a common cause of failure of chemotherapeutic drugs over the course of treatment.

In animal models, the Company`s first polymer platinate clinical candidate, AP 5280, has delivered greater than 10 times the amount of platinum to tumors compared with cisplatin (the standard platinum formulation) at the maximum tolerated dose, and formed at least 11 times more platinum-DNA adducts. The formation of these adducts is generally thought to be the main reason why platinum compounds have the ability to kill tumor cells. Consequently, clinical outcome could be greatly improved as a result of the ability of the polymer platinate technology to deliver much more platinum to the tumor and form many more platinum-DNA adducts.

Brochures describing polymer platinate and preliminary data are available below.

Projected Product Advantages

In preclinical testing in animal models, the results achieved to date with polymer platinate would indicate the following potential attributes of the technology:

The physical size of the polymer minimizes interactions of the toxic platinum with normal cells reducing the side-effects of the compound.


The polymer significantly increases the circulation time of the compound in the blood stream allowing greater tumor accumulation.


Tumor biology allows the compound to accumulate and be retained enabling significantly greater concentrations of drug at the tumor site.


The linkage of the platinum to the polymer is designed to localize the release of drug to tumor cells.


The platinum release rate can be controlled through the molecular design.


The cellular uptake mechanism of a large molecule could bypass cell membrane associated resistance mechanisms.
Development Status

During the past 12 months, a phase I clinical study was initiated in Europe to determine the safety of the Company`s first polymer platinate clinical candidate, AP 5280. This study has not yet been completed, but it has demonstrated that AP 5280 is well tolerated, even at doses in excess of 20 times the maximum tolerated dose of cisplatin. At the same time, significant progress was made in improving the synthetic process for the manufacture of the compound, and in preparation for phase II clinical studies, in the scale-up of the manufacturing process.

The Company has continued its polymer platinate research by synthesizing and testing many more molecules. In mid-2001, Access provided some data to show that a DACH (DiAminoCycloHexane) analog, AP 5286, could suppress the growth of an aggressive tumor in animals over an extended period. Since that time, many more DACH analogs have been prepared and tested, and the Company will be selecting one of these compounds shortly with the intent of developing this compound as a clinical candidate.

Based upon the experience gained from the development of AP 5280 and the new DACH compounds, the Company`s scientist will continue to develop the polymer platinate technology. Through innovative molecular design, the Company believes that it can make further improvements to the ability of polymers to target tumors and deliver their payload of cancer-killing agents, leading to a new generation of chemotherapeutic agents which are highly effective yet demonstrate greatly reduced toxic side-effects.


Wer sich gerne detaillierter informieren möchte:

www.accesspharma.com/pdf/AP5280.pdf

http://www.accesspharma.com/pdf/AP5286.pdf


Das Info-Material spricht für sich. Ein ähnlicher sicherer Homerun, wie OraDisc, aber ungleich lukrativer...

[greenhorn1998]

Hey, einen wunderschönen guten Abend!

Wollte nur kurz sagen, dass ich auch investiert bin, leider schon seit Anfang des Jahres und zu etwas höheren Kursen. Sollte auf lange Sicht gesehen aber egal sein, hoffe ich zumindest.

Hier noch ein bisschen was für die Leseratten, nichts wirklich neues:

http://www.accesspharma.com/pdf/diversified.pdf

Gruß, greenhorn

[Neoe]

Hi greenhorn,

ich denke wir erleben hier kurzfristig aufregende Zeiten. Wenn alles nach Plan läuft ist Access Pharma bis Jahresende übern Berg und hat für die nächsten paar Jahre ein solides Fundament gelegt, dass sollte auch kurstechnisch honoriert werden.

[greenhorn1998]

Hallo zusammen!

In Anbetracht der Tatsache, dass es bei Access jederzeit zu guten Neuigkeiten hinsichtlich OraDisc kommen könnte und zudem mehrere Eisen unter Befeuerung stehen, finde ich das Volumen doch eher mau, muss ich sagen. Wie ist das zu deuten?

Gruß, greenhorn

[Neoe]

Hi greenhorn,

ich setze nach wie vor auf Access. Das Volumen mag gering sein aber die Tendenz ist eindeutig. Vor der OraDisc-Meldung gibt es aber noch nette Neuigkeiten:

PhaseI von AP5346 werden Ende September in Genf vorgestellt. Immerhin ein Blockbuster-Medikament und wenn man sich die Spezifikationen anschaut ein eher geringes Risiko in klinischen Studien zu versagen.

Ich denke OraDisc wird die Aufmerksamkeit, die diese Technologie verdient hätte, verwehrt. Ist natürlich nicht so interessant, wie manch anderes potentielle Wundermedikament, aber dafür umso lukrativer.
Immerhin ist mit der Zulassung auch ein Meilenstein von Wyeth fällig, dass lässt die Leute auf jeden Fall aufhören, wenn sich ein Pharmariese für diese Sache interessiert.
Das tatsächliche Potential von OraDisc ist unbestimmt, aber bis Ende 2005 werden immerhin Konsumgüter und Medikamente auf Basis dieser Technologie in einem 5 Milliarden Dollar Gesamtmarkt angeboten.
Ihr eigenes Produkt und das von Wyeth machen davon nur 200 Millionen aus.
Die kommenden Partner werden und müssen also gigantisch sein. Meiner Meinung nach wird Procter&Gamble (Atemerfrischer oder Bleeching) ein weiterer sein, aber lassen wir uns überraschen.

[BrauchGeld]

Hi Leute

Access Pharmaceuticals, Inc. Announces FDA Approval of OraDisc(TM) A
Thursday September 30, 7:30 am ET


DALLAS, Sept. 30 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (Amex: AKC - News) announced today the receipt of approval of our new drug application for OraDisc(TM) A from the United States Food and Drug Administration (FDA).
ADVERTISEMENT


OraDisc(TM) A is an improved delivery system for amlexanox, which has previously been approved by the FDA for the treatment of canker sores. The OraDisc(TM) technology is a proprietary mucoadhesive patch which gradually erodes and releases an active ingredient when applied to the inside of the mouth.

The approval of this new drug application provides for the use of the amlexanox mucoadhesive patch 2mg for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

Commenting on the approval, Kerry P. Gray, President and CEO of Access stated, "This is a landmark accomplishment for Access, we are proud not only of receiving the FDA approval but also the rapid development of this product which has taken only 4 years from the initial inventive steps. Importantly, we believe that gaining this approval is a validation not only of our business model but also the quality of our organization."

In the clinical program undertaken by Access for OraDisc(TM) A, pediatric patients 12 years of age and older were included in the studies. This has enabled us to extend the potential use of amlexanox to include patients 12-17 years of age which is considered an important patient group for this indication.

As previously reported, Access has expanded development activities utilizing its OraDisc(TM) technology to include a range of consumer products. The approval of the amlexanox mucoadhesive patch is a strong validation of the OraDisc(TM) technology and the Company`s ability to develop products in compliance with the strict guidelines necessary to conform with the FDA regulations.

Mr. Gray continued, "This is an important validation of the OraDisc(TM) platform technology. Access is currently developing numerous products which utilize this technology. The approval of OraDisc(TM) A represents an important event for potential strategic partners."


Grüss
B.M.

[Neoe]

Leider kommt das in der Nachricht gar nicht so richtig rüber, was das eigentlich bedeutet.

Amlexanox hat einen 100 Millionen Dollar Marktpotential, dass erst jetzt richtig beackert werden kann, da die Creme schwer anwendbar war im Mundbereich. Durch das Patch(OraDisc) ist das gelöst.

Zudem steht jetzt weiteren Lizenzabkommen nichts mehr im Weg, da wird es bald richtig klingeln.

Und morgen geht es schon weiter mit Phase-I-Daten von AP5346.

[Neoe]

Nicht zu vergessen:

Wyeth wird im Zusammenhang mit der OraDisc-Zulassung noch Meilensteinzahlungen leisten.

[BrauchGeld]

Hallo !

Die Resultate sind da:

Access Pharmaceuticals, Inc. Announces Presentation of AP5346 Polymer Platinate Phase I Clinical Trial Results
Friday October 1, 7:30 am ET
- Study Shows Drug Has Favorable Toxicity Profile and Displays Efficacy -


DALLAS, Oct. 1 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (Amex: AKC - News) announced today that the results from the Phase I clinical trial of AP5346 a DACH Platinum Polymer Therapeutic were presented on Friday, October 1, 2004 at the 16th EORTC-NCI-AACR Symposium in Geneva, Switzerland as a poster presentation.
The study was designed to identify the maximum tolerated dose, dose limiting toxicities, the pharmacokinetics of the platinum in plasma and the possible antitumor activity of AP5346. The open-label, non-randomized, dose- escalation Phase I study was performed at two European centers. AP5346 was administered as an intravenous infusion over one hour, once a week on days 1, 8 and 15 of each 28-day cycle to patients with solid progressive tumors. The presentation reports on results in 19 patients with a broad cross-section of tumor types, with doses ranging from 80-1,280 mg Pt/m2.

Of the 19 patients, 7 were not evaluable for tumor response, principally due to withdrawal from the study prior to completing the required cycle. Of the 12 evaluable patients, 2 exhibited a response, 1 of whom demonstrated a partial response and 1 of whom experienced stable disease. The patient responding was a melanoma patient with a lung metastasis, which a CT scan revealed a tumor decrease of greater than 50%. Also of note, a patient with cisplatin resistant cervical cancer showed a short lasting significant reduction in lung metastasis after 3 doses. However, due to toxicity, the patient could not be retreated to determine whether the partial response could be maintained.

David P. Nowotink, Ph.D., Senior Vice President Research and Development at Access who presented the poster in Geneva stated, "In Phase I oncology studies, patients treated are generally end-stage, having failed numerous treatments including, in most cases, platinum therapy. We are, therefore, very encouraged that we saw evidence of efficacy of AP5346 in this study, as it is not unusual that promising drugs may not display any signs of efficacy in this type of patient population."

The dose limiting toxicity was established as neutropenia. Other dose related toxicities included nausea, vomiting, asthenia, fatigue and diarrhea. Renal toxicity, electrolyte imbalances and anemia were also observed which occurred principally at the highest doses administered.

Dr. Nowotnik continued, "The toxicities associated with AP5346 are those expected of a platinum agent and are manageable in cancer therapy. One important finding was that an expected toxicity was not seen. The active agent of AP5346 is a DACH Platinum, which is also the active agent of oxaliplatin, for which an acute neurotoxicity, peripheral neuropathy, is the most frequently observed dose-limiting toxicity. There was no evidence of any acute neurotoxicity associated with AP5346 during the Phase I study. This finding is consistent with our preclinical data. It has recently been reported in the scientific literature that the acute neurotoxicity associated with oxaliplatin probably results from oxalic acid, which is released from oxaliplatin in the body. AP5346 is formulated without oxalic acid which may account for this favorable toxicity profile."

AP5346 was developed based on the principles of polymeric drug delivery in order to improve the therapeutic index (greater activity and less toxicity) of platinum agents. As growing tumors establish their blood supply, they develop vasculature which is permeable to circulating large molecules such as AP5346. Also tumors often have poor drainage systems that allow for these large molecules to be trapped and concentrated in tumors. AP5346 was also designed to remain inactive in the plasma, and to become activated only after entering the tumor cell. The results of the Phase I study suggest that only a small fraction of the platinum is released from the polymer in plasma, indicating that this design goal was met.

Recently, additional preclinical studies of AP5346 have been completed which further add to the strong preclinical package which has been developed for AP5346. In a platinum resistant animal tumor model, AP5346 was significantly more effective than oxaliplatin.

Dr. Nowotnik continued, "Demonstrating superiority in a platinum resistant animal tumor model is yet another piece of supportive data which adds to our excitement for the potential of AP5346 in the treatment of numerous cancers."

Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. Access markets Aphthasol® and is developing products for mucositis and other oral indications. Access is also developing unique polymer platinates for use in the treatment of cancer and has an extensive portfolio of advanced drug delivery technologies including vitamin mediated targeted delivery, oral delivery, and nanoparticle aggregates.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties, including but not limited to statements made relating to the results of our polymer platinate program, the results of preclinical and clinical studies for our polymer platinate products, indications of efficacy of AP5346 in patients in a clinical study, the resumption of supply of Aphthasol®, projected milestone payments, the OraDisc(TM) program and our ability to achieve milestones. These statements are subject to numerous risks, including but not limited to the uncertainties associated with research and development activities, clinical trials, our ability to raise capital, the timing of and our ability to achieve regulatory approvals, dependence on others to market our licensed products, collaborations, future cash flow, the timing and receipt of licensing and milestone revenues, projected future revenue growth and our ability to generate near term revenues, the future success of the Company`s marketed products Aphthasol® and products in development including polymer platinate, OraDisc(TM) and our Mucositis technology, our ability to develop products from our platform technologies, our ability to manufacture amlexanox products in commercial quantities, our sales projections and the sales projections of our licensing partners, our ability to achieve licensing milestones and other risks detailed in the Company`s Annual Report on Form 10-K for the year ended December 31, 2003, and other reports filed by us with the Securities and Exchange Commission.


Grüsse
B.M.

[Neoe]

Bin hier im Laufe des Mittages ausgestiegen. Nächste Woche gibt es eine Konferenz, für die die ihr Glück hier versuchen wollen.

[BrauchGeld]

Hi Neoe

Was war dein grund für den Ausstieg ?
Ich denke wir könnten hier bald neue höchstkurse sehen.

Grüsse
B.M.

[js200]

RAiDAR alerts Learn More About RAiDAR-LT


10/01/2004 (10:19 ET) AKC: Filed 8-K Regarding AP5346 Polymer Platinate Trial (Oct-01 PR) - Knobias



10/01/2004 (10:16 ET) AKC: Filed New Form 8-K - Edgar



10/01/2004 (07:35 ET) AKC: Presents Phase 1 Results of AP5346 Polymer Platinate - Knobias



10/01/2004 (07:30 ET) Access Pharmaceuticals, Inc. Announces Presentation of AP5346 Polymer Platinate Phase I Clinical Trial Results - PR Newswire



09/30/2004 (17:05 ET) AKC: Filed 8-K Regarding FDA Approval of OraDisc(TM) A (Sep-30 PR) - Knobias



09/30/2004 (16:33 ET) AKC: Filed New Form 8-K - Edgar



09/30/2004 (10:56 ET) AKC: Volume Spike; 210% > 20-adsv, Stock +5.73% - Knobias



09/30/2004 (08:00 ET) StreetInsider Alert for AKC - Street Insider



09/30/2004 (07:34 ET) AKC: FDA Approves Mouth Ulcer Drug - OraDisc(TM)A - Knobias



09/30/2004 (07:30 ET) Access Pharmaceuticals, Inc. Announces FDA Approval of OraDisc(TM) A - PR Newswire



09/24/2004 (12:27 ET) AKC: Filed New Form 4 - Edgar



09/21/2004 (16:13 ET) AKC: Short Interest UP 18.3% to 94.1K in Sep 2004 - Knobias


JS200

[Neoe]

brauchgeld:

Rein theoretisch halte ich neue Höchstkurse hier für machbar, aber im Vergleich zu anderen Unternehmen der Biotech-Branche ist das nicht mehr wirklich billig, was ich allerdings erst durch neuere Informationen so sehe:

1. Grundsätzlich wird das Krebsprogramm von Access vermutlich nicht so hoch bewertet werden, wie Behandlungsansätze mit monoklonalen Antikörpern oder Telomerase, etc...(einfach weniger interessant, da chemotherapeutischer Ansatz)

2. Unter Umständen könnte OraDiscB klinische Tests benötigen, bevor eine Zulassung möglich ist.

3. Wyeth bezahlt Meilensteine nur im Zusammenhang mit OraDiscB, also jezt keine Zahlung.

4. Das Marktpotential für Amlexanox liegt anscheinend insgesamt bei 100 Millionen Dollar, ich bin für die USA alleine von 100 Millionen ausgegangen.


Aber:

Man versucht Wyeth auch für OraDiscA(melaxanox) als Vertriebspartner zu gewinnen.
Zudem könnte natürlich ein anderer großer Partner ins Boot kommen (Procter&Gamble).
Auch die Vitamin-und Nanotech-Platform kann jederzeit für eine Überraschung gut sein.
Vielleicht findet man auch bald einen Partner für die Krebskomponente.


Ich denke, das mit einer Marketcap von 90 Millionen kurzfristig auch nochmal eine Bewegung nach unten möglich ist, vielleicht bin ich dann wieder dabei.

[greenhorn1998]

Wow, ein Glück, dass ich auf dem Weg nach unten bei rund 5 USD rausgespült worden bin, aus der Aktie. Zwar mit Verlust, der sich nach meinem Einstieg anfang des Jahres aber in Grenzen hält.

Gruß, greenhorn