Aufsteiger 2011

Company Overview

Marqibo^® (vincristine sulfate liposomes injection, OPTISOME™)
A Novel Targeted Nanoparticle-encapsulated Anti-Cancer Compound currently for Acute Lymphoblastic Leukemia (ALL) and Melanoma. Marqibo® has a robust safety database (over 600 patients) and has been extensively evaluated in lymphoid blood cancers such as non-Hodgkin’s lymphoma (NHL) and ALL. Hana has ongoing (or planned) clinical trials which may enable an accelerated approval in 2 indications. Future clinical trial development possible in multiple indications including NHL and melanoma.
More Details »

Alocrest™ (vinorelbine liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Breast and Lung Cancer. Alocrest™ has completed a Phase I dose-escalation trial demonstrating promising anti-cancer activity as well as acceptable and predictable toxicity. More Details »

Brakiva™ (topotecan liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Small-Cell Lung Cancer and Ovarian Cancer. Preclinical data demonstrate the value of Brakiva™ over conventional topotecan. More Details »

Menadione Topical Lotion - A Topical Compound for Skin Rash Associated with EGFR Inhibitors. Treatment with EGFR inhibitors such as Tarceva®, Erbitux® and Vectibix® are associated with an acne-form rash involving the face, neck and upper torso in approximately 75% patients. 50% of patients who manifest skin toxicity experience significant discomfort. This results in drug discontinuation or dose reduction in at least 10% and up to 30% of all subjects. Drug delivery is targeted to the normal location of the EGFR-containing skin cells at the dermal/epidermal junction without interfering with EGFR inhibition systemically at the level of the tumor.
More Details »

Form 8-K for TALON THERAPEUTICS, INC.

28-Dec-2010

Change in Directors or Principal Officers

http://biz.yahoo.com/e/101228/tlon.ob8-k.html

langsam könnte sich Talon richtung Norden bewegen :-)

Talon Therapeutics (OTCBB:TLON) plans to submit a new drug application with the FDA for priority review of its Marqibo oncology drug in the second quarter this year and is hoping for accelerated approval in the final quarter of the year.

“We are seeking accelerated approval based on data from our Phase 2 RALLY study where we demonstrated a 35% overall response rate using single agent Marqibo as third, fourth, fifth or sixth line treatment,” CEO Dr. Steven Deitcher says in an exclusive interview with BioTuesdays.com.  “This is the most heavily pretreated and advanced Acute Lymphoblastic Leukemia (ALL) population that has ever been described or studied in the literature.”

Dr. Deitcher, a hematologist and oncologist calls a 35% response rate in this population “very impressive”, adding that about 20% of the patients in the trial achieved a complete response, meaning “elimination of all blood, bone marrow and radiographic evidence of their disease, along with a very meaningful median survival.”

Dr. Deitcher points out that the best that has ever been reported with a single agent therapy in a similar or even in a less heavily pretreated population was a 4% complete response rate. “So, what we’ve done with single agent Marqibo, we think, will offer a transformational opportunity for this very sick population of adult patients and a means of bridging to getting a stem cell transplant which could be curative.” 

People with adult ALL have a poor prognosis, with a five-year survival rate of about 7%. Third-line therapies induce few responses and are highly toxic, because patients already have been heavily pretreated with up to eight different drugs during first and second therapy. And fourth-line or greater therapy is expected to induce no response, he adds.

“We believe people with ALL, like the population studied in RALLY, represents a very appropriate unmet medical need and an untapped commercial opportunity to bring our drug out into the field,” says Dr. Deitcher.

Marqibo is what he calls a “smart bomb” of the widely used chemotherapy vincristine, which is encapsulated in unique liposome nanoparticles, which Talon refers to as Optisomes. Conventional vincristine is widely used in adult ALL, childhood ALL, across the spectrum of lymphomas, multiple myeloma and many childhood solid tumors.

In the RALLY study, Talon, formerly Hana Biosciences, delivered two to three times the amount of vincristine per dose than with standard treatment. “That’s the magic,” he says. “You give more, and you give it in a more targeted fashion.”

Talon’s ultimate goal is to have Marqibo replace millions of doses of standard vincristine chemotherapy given each year worldwide. “The one and only drug that every single one of our patients received prior to getting into our studies was vincristine.”

If Marqibo is cleared by the FDA for use in additional, larger indications, Talon is looking at a multibillion-dollar potential. “The path we elected to follow was to provide a better vincristine,” Dr. Deitcher says. “This way, we will be able to provide a turbo charged version of vincristine to physicians who are already comfortable using the drug in their patients. Our way is designed to give them more bang for the dose.”

Marqibo’s Phase 2 data and its commercial potential played a large role in Warburg Pincus and Deerfield Management, an existing shareholder of Talon, agreeing to inject up to $100 million to purchase Talon convertible preferred shares in three tranches. The first tranche of $40 million closed last June, with Warburg Pincus having 90% of it. The preferred shareholders also have an option to purchase up to another $20 million in preferred shares prior to the FDA decision on Marqibo, and if Marqibo receives approval, they have another option to purchase up to a further $40 million.

Talon CFO Craig Carlson says many funds were reluctant to invest in the company, because it was using Phase 2 clinical data to seek approval for Marqibo. “Warburg Pincus had previously invested in Allos Therapeutics (NASDAQ:ALTH), which was in the same situation as we were, in terms of having data from a Phase 2 trial as their pivotal data,” he recalls. “So they went through that minefield with Allos, and it received an approval from the FDA.”

The FDA gave Allos accelerated approval of Fototyn in 2009 for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. There are other examples of the FDA approving a Phase 2 product, including clofarabine for the treatment of relapsed pediatric ALL and nelarabine for pediatric and adult T-cell ALL. They had complete response rates similar to Marqibo.

“So, our data and our approach are an established path forward,” Dr. Deitcher says. “If you have compelling data and no safety issues, our argument is that you should make these drugs available to these deathly ill individuals as long as your Phase 2 data adequately predicts meaningful clinical benefits.”

He says the investment by Warburg Pincus was a “tremendous external validation, not only of Marqibo, but also of the people and the team behind it. The financial commitments are exactly what we needed to be focused on reaching the ultimate goal of getting our drug approved.”

In the Phase 2 trial, the median age of patients was 32. “These are mostly young people with families, and there’s a lot of value in trying to save those lives,” Dr. Deitcher says.

In addition to statistical measures in the Phase 2 data, the trial produced meaningful patient outcomes. Among other things, 11 patients received stem cell transplants after being treated with Marqibo, and five patients had an overall survival of greater than one year. “The fact that we were able to clear all evidence of leukemia from the blood in 63% of patients after just one dose of Marqibo, and the fact that we had excellent response rates even in those patients who had their solid organs infiltrated with leukemia just shows that this is a very effective and very active agent in this population and it benefits patients,” he adds.

In Europe, Talon is exploring the potential of “authorization under exceptional circumstances” for Marqibo and plans to continue talks with the European Medicines Agency in the near future.

Marqibo’s initial indication of relapsed and refractory adult ALL has an annual incidence of 3,200 cases in the U.S. and Europe. But Dr. Deitcher says Talon has a strategy to add indications in much larger disease categories, including front-line ALL, where the incidence is 9,200 cases a year, and front-line non-Hodgkin’s lymphoma, where the incidence is about 132,000 cases a year. These two markets currently represent worldwide sales of about $4 billion.

Talon believes it could initially commercialize Marqibo in the U.S. for this orphan indication with a sales staff of around 10 people, because it already has strong relationships with most of the adult ALL physicians in the U.S., since most of them were part of the earlier clinical studies.

Outside the U.S., the company’s preference is to partner Marqibo. “One of the advantages of not being strapped for financial resources is that we have no need to take a deal now when we know that, even months from now, the value of the deal would be greater,” Dr. Deitcher says. “So the deal with Warburg Pincus and Deerfield has allowed us to wait for the best deal.”

Talon’s second major product is Menadione topical lotion, which recently completed a Phase 1 program and is poised to enter Phase 2 studies to address a painful and prominent skin rash caused by epidermal growth factor receptor (EGFR)-inhibitor oncology compounds such as Erbitux, Tarceva, Tykerb and Vectibix. Rash occurs in up to 90% of patients within weeks of treatment, leading to a dose adjustment or delayed treatment in about 70% of patients.

Menadione’s goal is to be the first-in-class therapeutic to target the underlying cause of this rash. The key findings in the Phase 1 studies with healthy volunteers and cancer patients established an appropriate lotion strength and found no appreciable absorption into the bloodstream, which is “super important to the success of the therapeutic, the regulatory pathway and the development of the drug,” he points out.

Besides planning for the Phase 2 program, Talon is also actively in talks to partner Menadione in order to move development forward as quickly as possible, Dr. Deitcher says.

When asked if a collaboration would likely involve one of the companies whose drug causes the rash, he replied, “We have had and are in discussions with companies that have vested interests in the drugs that cause the rash as well as companies who don’t.”

http://biotuesdays.com/2011/02/01/...accelerated-approval-of-marqibo/

Reason #8 - In early June 2010, Warburg Pincus committed $100 million for investment in Talon Therapeutics. vor ungefähr 7 Stunden via web

• Reason #7 - Marqibo could represent a $5 billion market opportunity if it is expanded into other indications. vor ungefähr 7 Stunden via web
• Reason #6 - Estimated sales for Marqibo for the ALL indication only could be well above $100 million per year. vor ungefähr 7 Stunden via web
• Reason #5 - Marqibo intended to replace standard vincristine chemotherapy. This is a multi-billion dollar market worldwide! 12:31 AM Feb 20th via web
• Reason #4 - Marqibo's NDA has potential accelerated approval in Q4 2011. Granted US FDA Orphan Drug and Fast Track Designations. 12:30 AM Feb 20th via web
• Reason #3 - TLON is about to submit a NDA (New Drug Application) in the first half of 2011. Submission will put it in investors' spotlight. 12:18 AM Feb 20th via web
• Reason #2 - TLON has successfully completed preclinical, phase 1, phase 2, pivotal trials for MARQIBO. 12:15 AM Feb 20th via web
• Let's start 2011 with Talon Therapeutics - http://www.talontx.com. Reason #1 - nobody is paying attention to its shares on the OTCBB. 12:11 AM Feb 20th via web
• I am going to share a few lucrative investment opportunities every year. These gems will be a fine addition to your investment portfolio. 12:06 AM Feb 20th via web

http://twitter.com/hiddentreasury

SOUTH SAN FRANCISCO, Calif., March 10, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON - News), today announced the issuance of U.S. patent 7,887,836 B2, which covers compositions and methods for treating lymphoma, leukemia and myeloma for Marqibo (vincristine sulfate liposome injection). The patent expires in March 2020. A previously issued patent covers Marqibo's use for treating relapsed acute lymphoblastic leukemia (ALL).

"We believe Marqibo has the potential to be an effective treatment beyond our initial sought indication of adult Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy," stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Talon Therapeutics. "We are pleased the newly issued patent broadens our potential disease coverage to include lymphoma, leukemia and myeloma for front line and relapsed treatment."

Pursuant to its license agreement with Tekmira and related sublicense with the University of British Columbia, Talon has exclusive rights to 14 issued U.S. patents (including the newly-issued patent), 78 issued foreign patents, 4 pending U.S. patent applications and 19 pending foreign applications, covering composition of matter, method of use and treatment, formulation and process. These patents and patent applications cover sphingomyelin and cholesterol liposome-based pharmaceutical compositions including Marqibo and two other compounds, formulation, dosage, process of making the liposome compositions, and methods of use of the compositions in the treatment cancer, relapsed cancer, and solid tumors.

About Marqibo(R) (vincristine sulfate liposome injection)

Marqibo is a novel, targeted Optisome(TM) encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of adult Ph- ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.

Based on the data from the Phase 2 pivotal RALLY study, in the first half of 2011 Talon plans to submit to the FDA a New Drug Application, or NDA, seeking accelerated approval of Marqibo in Ph- adult ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.

Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult leukemia from the European Medicines Evaluation Agency.

About Talon Therapeutics

Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.

In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.

Additional information on Talon Therapeutics can be found at www.talontx.com.

The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing of planned regulatory filings relating to Marqibo, Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, and the potential of Marqibo to replace existing therapies. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that the results of the clinical trials of Marqibo will support Talon's claims or beliefs concerning Marqibo's safety and effectiveness; and that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion, Talon's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Talon assumes no obligation to update these statements, except as required by law.

http://finance.yahoo.com/news/...alon-pz-2520521653.html?x=0&.v=1

Babelfish übersetzung..

http://de.babelfish.yahoo.com/...p=en_de&btnTrUrl=%C3%9Cbersetzen

SOUTH SAN FRANCISCO, Calif., March 14, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics (OTCBB:TLON - News), announced that Steven R. Deitcher, M.D., President and Chief Executive Officer, is scheduled to present an overview of the company and its pipeline programs on Tuesday, March 15, 2011, at 5:00 PM Pacific Time at the Roth Capital Partners 23^rd Annual OC Growth Stock Conference. A live audio web cast of the presentation will be available on the company's website at www.talontx.com.

About Us

Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.

In the first half of 2011, Talon plans to submit to the FDA a New Drug Application, or NDA, seeking accelerated approval of Marqibo (vincristine sulfate liposome injection) in Philadelphia chromosome negative acute lymphoblastic leukemia (ALL), in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy. Talon has additional pipeline opportunities some of which, like Marqibo, have the potential to improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.

Additional information on Talon Therapeutics can be found at www.talontx.com.

The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing of planned regulatory filings relating to Marqibo, Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- ALL, and the potential of Marqibo to replace existing therapies. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that the results of the clinical trials of Marqibo will support Talon's claims or beliefs concerning Marqibo's safety and effectiveness; and that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion, Talon's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Talon assumes no obligation to update these statements, except as required by law.

http://finance.yahoo.com/news/...sent-pz-2126627710.html?x=0&.v=1

Talon Therapeutics to Host a Conference Call to Report Fourth Quarter and Full Year 2010 Results and Business Update on March 28, 2011

Companies:

• TALON THERAPEUTICS

SAN MATEO, Calif., March 24, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON - News) will host a conference call on Monday, March 28, 2011 at 8am PT, to include a discussion of results and highlights of the fourth quarter and full year 2010 and a business update. 

Conference call details:

An archived version of the webcast will also be available via the company's website following the call.

About Talon Therapeutics, Inc.

Talon Therapeutics, Inc. is a South San Francisco-based biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees.

The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290 

http://finance.yahoo.com/news/...st-a-pz-3584974123.html?x=0&.v=1

Aus den USA Forum

http://messages.finance.yahoo.com/...amp;mid=2609&tof=2&frt=2

TLON-DD /Once in a Lifetime Opprtunity !!!

This is a real unknown gem ,once investors discover this stock it will explode like a nuclear bomb .LOAD UP THE TRUCK WHILE YOU STILL CAN !!

NDA filing for Blockbuster Marqibo next quarter and it could be approved before the end of this Year .

MARKET CAP OF 10 MILLION MAKES ME A BIG LAUGH // TLON WILL MOVE INTO DOUBLE DIGITS IN THE COMING MONTHS !!

Market Cap: $10,4 Mil
Cash: 27,2 Mil

Shares Out: 21,2 Mil

New Presentation // A MUST READ !!
http://www.talontx.com/pdf/talontx_corp_pres.pdf

Marqibo® is poised for accelerated approval in 4Q 2011
NDA submission and request for priority revue expected in 2Q 2011
Sought indica<on =Adult Ph(-&#8208;)ALL in 2nd relapse or that has failed 2lines of Rx
35% overall response rate as 3rd-­6th line treatment in RALLY study
20% complete response rate with impressive median dura<on and survival

.................

http://biotuesdays.com/2011/02/01/...accelerated-approval-of-marqibo/

Talon Therapeutics (OTCBB:TLON) plans to submit a new drug application with the FDA for priority review of its Marqibo oncology drug in the second quarter this year and is hoping for accelerated approval in the final quarter of the year.

“We are seeking accelerated approval based on data from our Phase 2 RALLY study where we demonstrated a 35% overall response rate using single agent Marqibo as third, fourth, fifth or sixth line treatment,” CEO Dr. Steven Deitcher says in an exclusive interview with BioTuesdays.com. “This is the most heavily pretreated and advanced Acute Lymphoblastic Leukemia (ALL) population that has ever been described or studied in the literature.”

If Marqibo is cleared by the FDA for use in additional, larger indications, Talon is looking at a multibillion-dollar potential !

..................................................... .............

Sentiment : Strong Buy

Das schaut ganz gut aus ;-)

http://www.talontx.com/pdf/talontx_corp_pres.pdf

^^ wohoo

Es schaut ganz gut aus ;-))

Dann haben wir erst recht ein grund freudesprunge zu machen für den anfang winken 5 Millarden umsatzt ;-)

Das warten hätte sich mehr als gelohnt  :-)))