Cell Therapeutics: Enticing To All, Convincing To None
The Behavioral Economist • 30 Comments
The Behavioral Economist • 30 Comments
Tue, May 10, 4:41 PM
Tue, Feb. 16, 4:50 PM
Tue, Feb. 9, 9:59 PM
- After reviewing interim overall survival data in CTI BioPharma's (NASDAQ:CTIC) PERSIST-2 clinical trial assessing lead product candidate pacritinib, the FDA has informed the company that its Investigational New Drug (IND) application has been placed on full clinical hold. The basis for the decision was a similar detrimental effect on survival in PERSIST-2 that was observed in PERSIST-1.
- The deaths in PERSIST-2 include intracranial hemorrhage, cardiac failure and cardiac arrest.
- Full clinical hold means that no new patients can be recruited for the trials and all currently enrolled patients taking pacritinib must cease immediately. The company has withdrawn its New Drug Application (NDA), completed a month ago, until it has had the time to thoroughly review the data in PERSIST-2.
- The agency's current recommendations include conducting dose exploration studies of pacritinib in patients with myelofibrosis, submitting final study reports and datasets for both PERSIST trials, providing certain notifications, revising certain statements in the investigator's brochure and informed consent documents and modifying the protocols.
- The FDA has recommended to the company that it request a meeting prior to submitting a response to full clinical hold.
- Shares are down 46% premarket on robust volume.
- Previously: FDA places clinical studies of CTI Bio's lead product candidate on partial clinical hold due to excess mortality; shares drop 27% premarket (Feb. 8)
Mon, Feb. 8, 12:46 PM
Mon, Feb. 8, 9:19 AM
Mon, Feb. 8, 7:33 AM
- Micro cap CTI BioPharma (NASDAQ:CTIC) is down 27% premarket on average volume in response to its announcement that the FDA has placed clinical studies of lead product candidate pacritinib on partial clinical hold due to excess mortality and other adverse events in pacritinib-treated patients compared to control in the PERSIST-1 clinical trial. The abnormal mortality was most pronounced during the non-randomized crossover period following the initial 24 weeks of randomized treatment where patients in the control arm could switch to pacritinib.
- Partial clinical hold means that no new patients can be recruited for any study or start pacritinib as initial or crossover treatment. Also patients not benefiting from pacritinib treatment after 30 weeks should cease taking pacritinib.
- The FDA has recommended that the company modify its protocols for randomized studies to disallow crossover to pacritinib, provide certain notifications, revise certain statements in the investigator's brochure and informed consent documents and other actions.
- CTI intends to submit the requested modifications as soon as possible. The FDA will notify it afterward whether it can continue clinical studies under its IND.
- Pacritinib, an oral tyrosine kinase inhibitor, is under development for the potential treatment of certain blood-related cancers.
- Previously: CTI Bio completes rolling submission of pacritinib NDA (Jan. 5)
Tue, Jan. 5, 7:35 AM
- CTI BioPharma (NASDAQ:CTIC) completes its rolling submission of its New Drug Application (NDA) for Fast Track-tagged pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts less than 50K per microliter, a population with limited treatment options. The company has requested Priority Review of the application which, if granted, will shorten the review clock to six months from the standard 10 months.
- When approved, the company will jointly commercialize pacritinib with Baxalta (NYSE:BXLT) in the U.S. Baxalta has exclusive commercialization rights worldwide ex-U.S. for all indications.
- In premarket trading, CTIC is up 3% and BXLT is up 2%, both on light volume.
- Previously: CTI Bio initiates rolling pacritinib NDA submission for rare bone marrow disorder (Nov. 23, 2015)
- Previously: CTI Bio initiates preferred stock offering as it prepares for U.S. pacritinib launch (Dec. 3, 2015)
Dec. 14, 2015, 7:57 AM
- CTI BioPharma (NASDAQ:CTIC) receives a $10M milestone payment from Teva Pharmaceutical Industries (NYSE:TEVA) for the achievement of sales milestones for TRISENOX (arsenic trioxide). It is eligible to receive up to an additional $70M in sales and development milestones pursuant to an agreement with Cephalon, which Teva acquired in October 2011.
- TRISENOX is indicated for induction of remission and consolidation in patients with a certain genetic profile of acute promyelocytic leukemia (APL) who are refractory to or have relapsed from retinoid and anthracycline chemotherapy.
Dec. 7, 2015, 9:19 AM| Dec. 7, 2015, 9:19 AM | 714 Comments
Dec. 4, 2015, 12:44 PM
Dec. 4, 2015, 11:50 AM
- CTI BioPharma (CTIC -13.7%) prices its public offering of 55,000 shares of Series N-2 Preferred Stock at $1,000 per share, each convertible into common stock at $1.10 (50M shares). Holders may convert at any time at their option. Closing date is December 9.
- Previously: CTI Bio initiates preferred stock offering as it prepares for U.S. pacritinib launch (Dec. 3)
Dec. 3, 2015, 10:38 PM
- CTI BioPharma (NASDAQ:CTIC) commences a public offering of its Series N-2 Preferred Stock at $1,000 per share. Net proceeds will fund the commercial launch of pacritinib in the U.S. for myelofibrosis, additional research into new indications for pacritinib, advancement of commercialization of PIXUVRI, support the clinical development of tosedostat and general corporate purposes.
- Volume and conversion terms are not disclosed yet, but the company's $50M Series N-1 Preferred Stock offering, executed in October, was convertible into 800 shares of common at a price of $1.25.
- Previously: CTI Bio prices $50M equity offering (Oct. 27)
- Previously: CTI Bio initiates rolling pacritinib NDA submission for rare bone marrow disorder (Nov. 23)
Nov. 23, 2015, 9:19 AM
Nov. 23, 2015, 6:53 AM
- CTI BioPharma (NASDAQ:CTIC) begins its rolling submission of its New Drug Application (NDA) for lead product candidate and Fast Track-tagged pacritinib for the treatment of patients with intermediate and high risk myelofibrosis with low platelet counts (<50K/uL). If approved, pacritinib will be the first drug approved for the indication and the first JAK2 inhibitor. The submission should be completed by year end.
- CTI is co-developing pacritinib with Baxalta (NYSE:BXLT). The companies will jointly commercialize the product in the U.S. while Baxalta has exclusive commercialization rights ex-U.S.
- Myelofibrosis is a rare, serious and life-threatening chronic bone marrow disorder caused by the accumulation of malignant bone marrow cells that trigger an inflammatory response that scars the bone marrow. It strikes ~18K Americans each year.
- Previously: CTI BioPharma up 18% on positive results for pacritinib in rare blood cancer (June 1)
- Previously: FDA Fast Tracks CTI blood cancer drug (Aug. 7, 2014)
Nov. 5, 2015, 4:06 PM
- CTI BioPharma (NASDAQ:CTIC): Q3 EPS of -$0.19 misses by $0.07.
- Revenue of $1M (-97.5% Y/Y)
Oct. 27, 2015, 12:21 PM
- CTI BioPharma (CTIC -15.5%) prices its public offering of 50K shares of its Series N-1 Preferred Stock at $1,000 per share. Each share of N-1 Preferred is convertible into 800 shares of common stock at a conversion price of $1.25 per share.
- Net proceeds will help fund the commercial launch of pacritinib in the U.S., additional research into indications for pacritinib beyond myelofibrosis, advance the commercialization of PIXUVRI, to support the development of tosedostat and general corporate purposes. Closing date is October 30.
CTI BioPharma Corp. operates as a biopharmaceutical company, which is focused on the acquisition, development, and commercialization of less toxic and more effective ways to treat cancer. Its products include Pixuvri, Pacritinib, Tosedostat and Opaxio. The company was founded by James A. Bianco,... More
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