Point Therapeutics - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Point Therapeutics (POTP) veröffentlichte Anfang des Jahres Blockbuster verdächtige Ergebnisse zum Krebsmedikament Talabostat in phase2.
Vor kurzem wurde die Phase3 des Talabostat begonnen.
Sollten die Daten ähnlich positiv ausfallen könnte der Kurs der Aktie dramatisch ansteigen.

Marktkap:83mio$
Cash:24mio$
Kurs:3,50$

Point Therapeutics Presents Positive Results in Phase 2 Talabostat Non-Small Cell Lung Cancer Study; 2 Complete Responders, 3 Partial Responders and an Increase in Progression Free Survival

BOSTON, May 17, 2005 (BUSINESS WIRE) -- Point Therapeutics, Inc. (NASDAQ:POTP) presented positive results in the Company`s Phase 2 study of talabostat in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) in a second or third line setting in a poster session today at the American Society of Clinical Oncology Annual Meeting in Orlando, FL.

The company announced that 36 evaluable patients have completed the 18-week treatment period. These patients had all previously failed first-line treatment for NSCLC. To date, five patients have demonstrated a clinical response to treatment. Two patients had a complete response, defined as a complete disappearance of their tumor. In addition, three patients had a partial response--one with a 92% decrease in lesion size, one with a 66% decrease in lesion size and one with a 52% decrease from maximum disease burden. These results led to an overall response rate of 13.9%. In addition, results on the secondary endpoint of progression free survival (PFS) were also positive with a median PFS of 4.0 months compared to the historically reported median of 2.9 months for docetaxel alone. At this time, median survival cannot be calculated due to a lack of deaths in the study.

"I am very excited about the study results. The desired tumor response has been observed in 5 patients. Two of these patients had a complete response, which is very unusual and quite significant in a second or third line setting in advanced non-small cell lung cancer," said Dr. Casey Cunningham, the lead investigator in the study at Mary Crowley Medical Research Center in Dallas, TX and a member of Point`s Clinical Advisory Board.

Dr. Maggie Uprichard, Senior Vice President and Chief Development Officer at Point, added, "In addition to seeing the desired tumor response, importantly, we also saw a significant increase in progression free survival - a key clinical endpoint for regulatory approval in non-small cell lung cancer. Point is actively planning for the launch of a pivotal Phase 3 program in the second half of this year for non-small cell lung cancer and we believe these results position us very well."

The addition of talabostat did not significantly alter the safety profile of docetaxel. The most common adverse events were edema, fatigue and leukopenia, all of which were generally manageable and reversible. At the dose level demonstrating the optimal clinical response, the incidence of Grade 3/4 neutropenia or febrile neutropenia is similar to that reported historically for single-agent docetaxel. There were no reports of Grade 3/4 anemia.

The combination study of talabostat with docetaxel is an open-label, single-arm, Phase 2 trial in a second or third line setting in patients with Stage IIIB/IV NSCLC, using the Simon 2-stage design. The primary study endpoint is objective response rate, defined as a greater than 50% reduction in tumor size. Secondary endpoints include survival, duration of response, time to progression and incidence of clinically-significant events of neutropenia or anemia.

Point also announced that it will hold a Research and Development Event to review recent clinical progress and data on June 1, 2005 from 4:30 p.m. to 6:30 p.m. at the Four Seasons Hotel in New York City, which will also be Web cast. For additional information on the event, please contact Sarah Cavanaugh at 617-933-7508.

Upcoming Milestones:

Talabostat Trials Clinical Development Target Date
Milestones
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Pancreatic Cancer w/gemcitabine Initiation of Phase 2 Q2 2005
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CLL w/rituximab Interim Phase 2 go/no-go Q3 2005
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NSCLC w/docetaxel Initiation of Phase 3 Q4 2005
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Melanoma Phase 3 go/no-go Q4 2005
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[BrauchGeld]

Point Therapeutics Initiates Phase 3 Program in Metastatic Non-Small Cell Lung Cancer
Thursday October 13, 4:38 pm ET


BOSTON--(BUSINESS WIRE)--Oct. 13, 2005--Point Therapeutics, Inc. (NASDAQ: POTP - News) announced today that it initiated its Phase 3 program in metastatic non-small cell lung cancer (NSCLC). This news follows a successful End-of-Phase 2 meeting with the Food and Drug Administration.
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"We are pleased with our End-of-Phase 2 meeting discussions with the FDA and the fact that there were no major changes to the Phase 3 study protocols. We look forward to continuing to clinically develop talabostat in this advanced lung cancer population," said Dr. Margaret Uprichard, Chief Development Officer and Senior Vice President of Point Therapeutics.

Point`s Phase 3 program will further evaluate the company`s lead compound, talabostat, in patients with Stage IIIB/IV NSCLC after failure of a platinum-based chemotherapy. The program will consist of two randomized, double-blind, placebo-controlled trials in up to 800 patients at approximately 100 sites in North America. The first 400-patient trial has opened to enrollment. This trial will evaluate talabostat in combination with docetaxel versus docetaxel with placebo. The second 400-patient trial will evaluate talabostat in combination with pemetrexed versus pemetrexed with placebo. Docetaxel and pemetrexed are the current standard of care in this advanced patient population. The primary study endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, complete response, duration of response and quality of life.

"I am encouraged by the positive results in Point`s Phase 2 trial of talabostat and docetaxel. As reported at this year`s ASCO meeting, five patients demonstrated at least a 50% reduction in tumor size--of which two had a complete response, defined as a complete disappearance of their tumor. To see complete responders in a second or third line setting in advanced non-small cell lung cancer is rare and merits further study," said Dr. Casey Cunningham, an oncologist at Mary Crowley Medical Research Center in Dallas, TX and a member of Point`s Clinical Advisory Board. "Talabostat has the potential to become an important treatment for non-small cell lung cancer and the initiation of Point`s Phase 3 program is a significant step towards achieving this goal," concluded Dr. Cunningham.

"Initiating our Phase 3 registration program in non-small cell lung cancer is an important milestone for the company. This program, if successfully completed, is expected to be the basis of our first registration package with the regulatory authorities," said Don Kiepert, President and CEO of Point Therapeutics, Inc. "Talabostat has several characteristics that make it an attractive drug candidate-it is orally available and has the potential to be used in both solid and hematologic malignancies and in combination with a range of chemotherapies, monoclonal antibodies and other forms of cancer treatment," added Kiepert. "We are very excited to begin our Phase 3 program in a serious disease where a need for more treatment options exists."

According to the American Cancer Society, lung cancer is the leading cause of cancer death among men and women in the United States--with nearly 60% of people diagnosed dying within one year and nearly 75% dying within two years. 87% of all lung cancers are non-small cell. While treatment options for NSCLC continue to emerge, mortality rates have not improved in the last 10 years, leaving a significant need for advancement in current therapies.

[BrauchGeld]

Point Therapeut. "buy-and-hold-Wert"

21.06.2005
Global Biotech Investing

Die Experten des Börsenbriefs "Global Biotech Investing" sehen die Point Therapeuticals-Aktie (ISIN US7306941060 / WKN 908383) als "buy-and-hold-Wert".

Noch in diesem Jahr sollten Phase-3-Tests zur Wirksamkeit des Krebsmittel Talabostat aufgenommen werden. Wenn alles nach Plan verlaufe, könnte das Präparat im ersten Halbjahr 2009 die Zulassung erhalten. Die Analysten von RBC Capital Markets würden erwarten, dass das Medikament 3 Jahre nach Einführung einen Marktanteil von 20% erreichen und somit 1 Mrd. US-Dollar Umsatz anvisieren könnte. Bei einem Kurs von 4,30 US-Dollar weise die Gesellschaft derzeit eine Marktkapitalisierung von 96 Mio. US-Dollar aus, was für ein potenzielles Milliarden-Unternehmen lächerlich sei.

Die Aktie werde von RBC Capital Markets mit einem Kursziel von 9 US-Dollar zum Kauf empfohlen. Sollte die Gesellschaft 2009 wirklich 1,60 US-Dollar je Aktie verdienen, könnte der Kurs bei einem unterstellten KGV von 20 über 30 US-Dollar notieren.

Nach Ansicht der Experten von "Global Biotech Investing" ist die Point Therapeuticals-Aktie ein "buy-and-hold-Wert", der möglichst bis 2009 im Depot bleiben soll.

[BrauchGeld]

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[BrauchGeld]

Hallo

Potp könnte bald zu den grossen gewinner in der Krebsbekämpfung gehören.

http://library.corporate-ir.net/library/10/103/103445/items/…

[BrauchGeld]

Point Therapeutics Starts Phase III Talabostat Push

By Randall Osborne



West Coast Editor
Less than a month after disclosing the next step of its Phase II study with talabostat for leukemia - and days after winning an FDA grant for the drug - Point Therapeutics Inc. launched the most advanced trial yet with the compound, starting its Phase III program to test talabostat in metastatic non-small-cell lung cancer.

Having gained the FDA`s blessing in an end-of-Phase II meeting, Point will test its lead candidate in Phase III trials in patients afflicted with Stage IIIb/IV NSCLC who have failed platinum-based chemotherapy. Two trials will be conducted in as many as 800 patients at about 100 sites in North America.

"We plan to report results by the end of 2007," said Donald Kiepert, CEO, founder, president and chairman of Boston-based Point.

The first 400-patient study already has opened to enrollment and will evaluate oral talabostat in combination with docetaxel vs. docetaxel with placebo. The second will test the drug in combination with pemetrexed vs. pemetrexed with placebo. Docetaxel and pemetrexed are the current standard of care in that advanced patient population.

Progression-free survival is the primary endpoint, with secondary endpoints including overall survival, objective response rate, complete response, duration of response and quality of life.

Less than a week ago, Point said it had won an Orphan Products Development grant of $600,000 from the FDA to fund its Phase II study of talabostat in combination with rituximab in advanced chronic lymphocytic leukemia. The two-year award aims to encourage development of products for rare diseases or conditions, usually affecting less than 200,000 people in the U.S., and Point plans to finish the Phase II trial in CLL and decide whether to proceed with Phase III during the first quarter of next year. In September, the company completed the first stage of the Phase II study.

Talabostat also is being studied in two Phase II trials against Stage IV melanoma, as a single agent and with cisplatin.

"Those trials are fully enrolled, and we`ll be making a decision at the end of this year about whether or not we want to initiate a Phase III program," Kiepert said.

In June, Point began a Phase II trial with the compound combined with gemcitabine against metastatic pancreatic cancer. The indication "happens to be a really good tumor to target," he said, because of the unmet need and because of talabostat`s mechanism of action.

"If we got positive [Phase II] results in pancreatic cancer, that probably would be the fastest approval process," Kiepert said, but so far NSCLC takes the lead position.

"We had very compelling preclinical data to [move this into] our first Phase II," he said, adding that talabostat "stacks up very favorably with drugs that have been approved for second-line treatment."

In Phase II, five out of 36 patients responded, and two of those were complete, "which is highly unusual in second-line treatment," Kiepert noted. Of those two, one was second-line and one was third-line, and one had failed docetaxel. They were identified as complete responders in February and March, and are still being monitored.

DPP inhibitors also might work against Type II diabetes, since DPP-4 has been reported to regulate GLP-1, an important metabolic system signaling protein that promotes insulin secretion in response to dietary sugars. Point has PT-630, which has a high affinity to DPP-4, in preclinical study. Also at the early stage is PT-510 as a vaccine adjuvant for infectious diseases.

"We`re not aware of any other programs in development that work to this mechanism," Kiepert said, though he acknowledged as a contender Wellesley, Mass.-based Coley Pharmaceutical Group Inc.`s Toll-like receptor agonist ProMune, which is in Phase II trials for NSCLC, among other indications.

"A lot of companies are pursuing that approach," he said.

ProMune is partnered with Pfizer Inc., of New York. Point hopes to have a partner for talabostat by the middle of next year.

"This is a drug that, if approved, could have such broad use that really we need to make sure we have a good distribution channel," Kiepert told BioWorld Today. "We`ve been actively talking to potential partners, and our discussions have moved forward quite well."

The goal is to structure an arrangement that would split profits and allow Point to co-develop and co-promote.

"We would like to have a small sales force, to make sure we can protect our drug once it moves into the marketing phase," he said.

[BrauchGeld]

Kurs:4,10$

Point Therapeutics Awarded $600,000 Orphan Products Development Grant to fund Company`s Current Phase 2 Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia


BOSTON--(BUSINESS WIRE), 2005--Point Therapeutics, Inc. (NASDAQ: POTP - News) announced today that it has been awarded an Orphan Products Development Grant from the Food and Drug Administration to fund its Phase 2 study of talabostat in combination with rituximab in advanced chronic lymphocytic leukemia (CLL). On September 19, 2005, Point announced that it had achieved a 20% clinical response rate in the first 20 evaluable patients in the first stage of the company`s Phase 2 CLL study. This was the targeted response rate needed to continue the study to completion.

The $600,000 grant is a two-year grant funding costs related to the company`s ongoing Phase 2 CLL trial. Orphan Products Development grants are awarded by the Food and Drug Administration to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting less than 200,000 people in the United States. CLL is an incurable disease that usually affects people over 60 years of age. Patients who present with advanced stage disease or who progress to the state of requiring treatment have a poor outcome with a median survival of only 18 to 36 months.

"We are very pleased to be one of the few corporate programs to receive an Orphan Products Development Grant this year," said Don Kiepert, President and CEO of Point Therapeutics, Inc. "This award, coupled with the positive results we recently announced, positions Point to complete the Phase 2 CLL trial and make a Phase 3 go/no-go decision in the first quarter of 2006."