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This excerpt taken from the ALTH 8-K filed Dec 7, 2009. Item 8.01 Other Events.
On December 5, 2009, Allos Therapeutics, Inc. (the “Company”) issued a press release announcing new analyses of data from the Company’s pivotal PROPEL trial of FOLOTYNTM (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company also reported preliminary results from its Phase 1/2 study of FOLOTYN in combination with gemcitabine in patients with relapsed or refractory lymphoproliferative malignancies and certain other data presented during poster sessions at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Dec 7, 2009. Item 8.01 Other Events.
On December 7, 2009, Allos Therapeutics, Inc. (the “Company”) issued a press release announcing a new analysis of data from the Company’s pivotal PROPEL trial of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Dec 3, 2009. Item 8.01 Other Events.
On December 3, 2009, the Company issued a press release announcing the launch of COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), a global observational study designed to address the urgent need to better understand treatment patterns and outcomes for patients with peripheral T-cell lymphoma (PTCL). The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Oct 5, 2009. Item 8.01 Other Events.
On October 5, 2009, the Company issued a press release announcing that FOLOTYN™ (pralatrexate injection) is now available for commercial sale in the United States. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Sep 25, 2009. Other Events.
On September 25, 2009, the Company issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (“PTCL”). The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
FOLOTYN was approved for the treatment of patients with relapsed or refractory PTCL under the FDA’s accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. Under these provisions, the Company has agreed to the following post-marketing requirements (“PMRs”):
· a Phase 3, multi-center, randomized clinical study of sequential FOLOTYN versus observation in patients with newly diagnosed aggressive PTCL who have responded following initial treatment with chemotherapy based on CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone). The primary endpoint will be progression-free survival (“PFS”). Patients will be enrolled prior to initiation of the CHOP-based regimen. Patients responding (either a complete response or a partial response) after CHOP-based treatment will be randomized 2:1 to FOLOTYN versus observation. The Company has agreed to submit the results of this study by June 30, 2017.
· a Phase 3, multi-center, randomized clinical study comparing FOLOTYN in combination with systemic bexarotene versus systemic bexarotene alone in patients with cutaneous T-cell lymphoma who are refractory to at least one prior systemic therapy. The primary endpoint will be PFS. Response rate will be a secondary endpoint. Prior to initiation of the Phase 3 study, the Company will conduct a Phase 1 study to determine the maximum tolerated dose of the combination. The Company has agreed to complete the Phase 1 study by August 31, 2011 and submit the results of the Phase 3 study by September 30, 2015.
· a Phase 1 clinical study to evaluate the pharmacokinetics of FOLOTYN in relapsed or refractory lymphoma patients (B-cell, T-cell and Hodgkin’s lymphoma) with mild to severe renal impairment. The trial will have 3 cohorts of 6 patients for a total of 18 patients. Cohorts will be based on the severity of renal impairment: severely impaired, moderately impaired and mildly impaired. The FOLOTYN dose for the first two cohorts will be determined based on the pharmacokinetics experience from the PROPEL study and the third cohort will be dosed at the recommended dose (30 mg/m2). The Company has agreed to submit the results of this study by January 31, 2013.
· completion of an ongoing Phase 1 mass balance clinical study to evaluate the excretion and metabolic profile of FOLOTYN. The Company has agreed to submit the results of this study by December 31, 2010.
Failure to complete the studies or adhere to the timelines set by the FDA could result in penalties, including fines or withdrawal of FOLOTYN from the market, unless the Company is able to demonstrate good cause for not
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completing the studies or adhering to the timelines. The FDA may also initiate proceedings to withdraw approval if our Phase 3 PMR studies fail to verify clinical benefit of FOLOTYN.
Safe Harbor Statement
The information contained in this report on Form 8-K and the press release incorporated herein by reference should be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements that the Company may make, by press release or otherwise, from time to time. The information contained in this report on Form 8-K and the press release incorporated herein by reference includes forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include the Company’s statements regarding the potential for FOLOTYN to offer an important new treatment option or become a new standard for patients with relapsed or refractory PTCL; the Company’s anticipated timeline for making FOLOTYN available to patients in the U.S.; the Company’s intent to advance the FOLOTYN clinical development program; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Important factors that may cause actual results to differ materially include, but are not limited to, the risks and uncertainties associated with developing adequate sales, marketing and distribution capabilities; the acceptance of FOLOTYN in the marketplace; the status of reimbursement from third party payors; the Company’s dependence on third party manufacturers; the Company’s compliance with applicable regulatory requirements, including the healthcare fraud and abuse laws and the Company’s post-marketing requirements, including additional clinical trials; and the Company’s access to capital to support its future operations, including product development and commercialization plans for FOLOTYN. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this report on Form 8-K and the press release incorporated herein by reference.
All information contained in the press release and this report on Form 8-K is as of September 25, 2009. We undertake no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in our expectations.
This excerpt taken from the ALTH 8-K filed Sep 3, 2009. Item 8.01 Other Events.
On September 2, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Aug 10, 2009. Item 8.01 Other Events.
On August 10, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the Company has received notification from the U.S. Food and Drug Administration that the Oncologic Drugs Advisory Committee will hold a meeting on September 2, 2009, to review the Company’s New Drug Application for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Jul 7, 2009. Item 8.01 Other Events.
On July 7, 2009, Allos Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing the completion of patient enrollment in the Company’s randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva®) in patients with Stage IIIB/IV non-small cell lung cancer who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
This excerpt taken from the ALTH 8-K filed Jun 12, 2009. Item 8.01 Other Events.
Allos Therapeutics, Inc., a Delaware corporation (the “Company”), has distributed to its stockholders a proxy statement for its 2009 Annual Meeting of Stockholders to be held on June 23, 2009. Proposal 2 included in the proxy statement relates to approval of an amendment to the Company’s 2008 Equity Incentive Plan (the “Plan”) to increase the aggregate number of shares of common stock authorized for issuance under the Plan by 5,750,000 shares.
On June 12, 2009, the Compensation Committee of the Board of Directors of the Company amended the Plan to provide that if the exercise price of any stock award is satisfied by tendering shares of common stock held by a participant (either by actual delivery or attestation), then the number of shares so tendered shall not remain available for issuance under the Plan. Prior to such amendment, the Plan provided that if the exercise price of any stock award was satisfied by tendering shares of common stock held by a participant (either by actual delivery or attestation), then the number of shares so tendered would remain available for issuance under the Plan.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 12, 2009
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