Three Months Ended
For the three months ended
Total operating expenses for the three months ended
Nine Months Ended
For the nine months ended
Total operating expenses for the nine months ended
Cash used in operations was
Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is
Marqibo has received orphan drug designation for the treatment of ALL from the
Talon is currently conducting a Phase 3 clinical trial in adults aged 60+ with newly diagnosed ALL (HALLMARQ); a Phase 3 clinical trial in adults aged 60+ with newly diagnosed aggressive
Please see important safety information below and the full prescribing information for Marqibo at www.marqibo.com.
Indication and usage
Marqibo is a liposomal vinca alkaloid indicated for the treatment of adult patients with
Important safety information
See full prescribing information for complete boxed warning.
Warnings and Precautions
For Intravenous Use Only
For Intravenous use only. Fatal if given by other routes.
Extravasation Tissue Injury
Only administer through a secure and free-flowing venous access line. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures.
Sensory and motor neuropathies are common and are cumulative. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw pain, decreased vibratory sense, cranial neuropathy, ileus, burning sensation, arthralgia, myalgia, muscle spasm, or weakness, both before and during treatment. Orthostatic hypotension may occur. The risk of neurologic toxicity is greater if Marqibo is administered to patients with preexisting neuromuscular disorders or when other drugs with risk of neurologic toxicity are being given. In the studies of relapsed and/or refractory adult ALL patients, Grade > = 3 neuropathy events occurred in 32.5% of patients. Worsening neuropathy requires dose delay, reduction, or discontinuation of Marqibo.
Monitor complete blood counts prior to each dose of Marqibo. If Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops, consider Marqibo dose modification or reduction as well as supportive care measures.
Tumor Lysis Syndrome
Tumor lysis syndrome (TLS) may occur in patients with ALL receiving Marqibo. Anticipate, monitor for, and manage.
Constipation and Bowel Obstruction
Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. Marqibo can cause constipation. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction, and/or paralytic ileus, considering adequate dietary fiber intake, hydration, and routine use of stool softeners, such as docusate. Additional treatments, such as senna, bisacodyl, milk of magnesia, magnesium citrate, and lactulose may be considered.
Marqibo can cause severe fatigue. Marqibo dose delay, reduction, or discontinuation may be necessary.
Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Elevated levels of aspartate aminotransferase of Grade > =3 occurred in 6-11% of patients in clinical trials. Monitor hepatic function tests. Reduce or interrupt Marqibo for hepatic toxicity.
Marqibo can cause fetal harm when administered to a pregnant woman. Vincristine sulfate liposome injection was teratogenic or caused embryo-fetal death in animals. Women of childbearing potential should avoid becoming pregnant while being treated with Marqibo. There are no adequate and well-controlled studies of Marqibo in pregnant women and there were no reports of pregnancy in any of the clinical studies in the Marqibo clinical development program. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations].
The most common adverse reactions ( > 30%) were constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%).
The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%).
Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%).
Deaths occurred in 23% of patients in study 1. The non-leukemia related causes of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multi-system organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1).
No formal drug interaction studies have been conducted with Marqibo. Marqibo is expected to interact with drugs known to interact with non-liposomal vincristine sulfate.
Simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included non-liposomal vincristine sulfate has been reported to reduce blood levels of phenytoin and to increase seizure activity.
Vincristine sulfate, the active agent in Marqibo, is a substrate for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant use of strong CYP3A inhibitors should be avoided (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Similarly, the concomitant use of strong CYP3A inducers should be avoided (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's Wort).
Vincristine sulfate, the active agent in Marqibo, is also a substrate for P-glycoprotein (P-gp). The effect of concomitant use of potent P-gp inhibitors or inducers has not been investigated; it is likely that these agents will alter the pharmacokinetics or pharmacodynamics of Marqibo. Therefore the concomitant use of potent P-gp inhibitors or inducers should be avoided.
Use in Specific Populations
Pregnancy Category D [see Warnings and Precautions]
Based on its mechanism of action and findings from animal studies, Marqibo can cause fetal harm when administered to pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. In an embryofetal developmental study, pregnant rats were administered vincristine sulfate liposome injection intravenously during the period of organogenesis at vincristine sulfate doses of 0.022 to 0.09 mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal and visceral), decreases in fetal weights, increased numbers of early resorptions and post-implantation losses, and decreased maternal body weights Malformations were observed at doses > = 0.044 mg/kg/day in animals at systemic exposures approximately 20-40% of those reported in patients at the recommended dose.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
The safety and effectiveness of Marqibo in pediatric patients have not been established.
Safety and effectiveness in elderly individuals have not been established. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Marqibo has not been evaluated.
Non-liposomal vincristine sulfate is excreted primarily by the liver. The influence of severe hepatic impairment on the safety and efficacy of Marqibo has not been evaluated. The pharmacokinetics of Marqibo was evaluated in patients with moderate hepatic dysfunction (Child-Pugh B) secondary to melanoma liver metastases. The dose-adjusted maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) of Marqibo in patients with moderate hepatic impairment was comparable to the Cmax and AUC of patients with ALL who had otherwise normal hepatic function.
In addition to Marqibo(R), Talon has additional pipeline opportunities some of which, like Marqibo(R), 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
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 Talon's ability to secure a strategic partner to commercialize Marqibo(R), its ability to commercialize Marqibo(R) by itself if no such partner is secured, and the timing of Talon's ongoing and planned clinical trials. 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. Such risks and uncertainties include: Talon's lack of experience commercializing pharmaceutical products; that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo(R), to completion; Talon's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended
|CONDENSED BALANCE SHEETS|
|(In thousands, except per share data)|
|Cash and cash equivalents||
|Prepaid expenses and other current assets||404||635|
|Total current assets||5,987||1,664|
|Property and equipment, net||41||72|
|Debt issuance costs||557||751|
|Other long-term assets||34||—|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accounts payable and accrued liabilities||
|Other short-term liabilities||3||2|
|Total current liabilities||3,410||4,559|
|Notes payable, net of discount||24,626||24,033|
|Other long-term liabilities||1||2|
|Investors' right to purchase future shares of Series A-1 and A-2 preferred stock||—||1,772|
|Investors' right to purchase future shares of Series A-3 preferred stock||29,067||—|
|Total long term liabilities||54,525||26,309|
Redeemable convertible preferred stock;
10 million shares authorized; 0.6 and 0.4 million issued and outstanding as of
600 million shares authorized; 22.0 and 21.8 million shares issued and outstanding at
|Additional paid-in capital||134,444||120,887|
|Total stockholders' deficit||(96,259)||(59,024)|
|Total liabilities, redeemable convertible preferred stock and stockholders' deficit||
|CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME/(LOSS)|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|General and administrative||
|Research and development||5,333||2,385||10,247||11,061|
|Total operating expenses||7,389||3,349||15,484||14,782|
|Loss from operations||(7,389)||(3,349)||(15,484)||(14,782)|
|Other expense (including non-cash charges):|
|Other income/(expense), net||(2)||(1)||(1)||5|
|Change in fair market value of warrant liabilities||814||301||(340)||(495)|
|Impairment of available-for-sale securities||—||—||—||(76)|
|Change in fair value of rights to purchase shares of Series A-3 Preferred Stock||48,019||—||(31,137)||—|
|Change in fair value of rights to purchase additional shares of Series A-1 and A-2 Preferred Stock||—||3,235||(1,007)||836|
|Total other income/(expense)||47,884||2,643||(35,308)||(2,390)|
|Deemed dividends attributable to preferred stock in connection with accretion||(1,536)||(1,005)||(4,155)||(2,919)|
|Deemed dividends attributable to preferred stock in connection with embedded conversion features||(9,199)||—||(13,748)||—|
|Net income/(loss) applicable to common stock||29,760||(1,711)||(68,695)||(20,091)|
|Net income/(loss) per share, basic||
|Weighted average shares used in computing net income/(loss) per share, basic||21,968||21,775||21,899||21,473|
|Net income/ (loss) per share, diluted||
|Total shares used in the computation of diluted earnings per share||161,790||21,775||21,899||21,473|
|Unrealized holdings gains (losses) arising during the period||—||(12)||—||(60)|
|Less: reclassification adjustment for other-than-temporary impairment included in net loss||—||—||—||76|
Talon Therapeutics, Inc.Investor & Media Contacts: Investor Relations Team (650) 588-6641 firstname.lastname@example.org
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