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ONTX

Onconova

$3.93

-0.215 (-5.19%)

07:33
05/14/19
05/14
07:33
05/14/19
07:33

Onconova: Enrollment in Phase 3 IV rigosertib trial in HR-MDS is 'top priority'

"As we progress through 2019, we are advancing the clinical development of our pipeline and executing on our collaboration strategy, as highlighted by the recently announced license agreement for investigational rigosertib in Greater China with HanX Biopharmaceuticals," said Steven M. Fruchtman, M.D., President and CEO. "2019 is an important year for Onconova and we are working diligently to execute on our objectives. If successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years." Dr. Fruchtman added, "Enrollment in our Phase 3 intravenous rigosertib trial in second-line HR-MDS patients is continuing and is our top priority. We exceeded 75 percent enrollment of the study during the first quarter and are focused on completing enrollment in the second half of 2019 and reporting top-line data following full enrollment and 288 death events. We believe the addition of sites in Brazil and China later this year could contribute significantly to achieving our goal of completing enrollment by year end. We also look forward in the future to initiating a Phase 3 trial with oral rigosertib in combination with azacitidine in first-line HR-MDS patients and to filing an IND in the U.S. for ON 123300, a first-in-class CDK4/6 + ARK5 inhibitor for the treatment of a variety of advanced tumors." Cash and cash equivalents as of March 31, 2019, totaled $10.4M compared to $17M at December 31, 2018. The company expects that cash and cash equivalents at March 31, 2019 will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019. After receiving the upfront proceeds from the HanX rigosertib transaction, the company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the first quarter of 2020. Net loss was $7.6M for the quarter ended March 31, 2019, compared to $5.1M for the first quarter ended March 31, 2018. Research and development expenses were $4.1M for the quarter ended March 31, 2019, and $4.6M for the comparable period in 2018. General and administrative expenses were $3.2M for the quarter ended March 31, 2019, and $1.9M for the comparable period in 2018.

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    May

ONTX Onconova
$3.93

-0.215 (-5.19%)

10/11/18
MAXM
10/11/18
NO CHANGE
Target $16
MAXM
Buy
Onconova price target lowered to $16 at Maxim to reflect reverse stock split
Maxim analyst Jason MacCarthy lowered his price target on Onconova to $16 from $45 to reflect the impact of the company's 1-for-15 reverse stock split announced on September 25th which reduced the number of shares outstanding to 5.67M from 85.11M. McCarthy also keeps his Buy rating on the shares and notes that his bullish stance remains intact as the company's "rigosertib phase 3 program continues to enroll and timelines remain unchanged".
12/03/18
12/03/18
NO CHANGE

Onconova presents rigosertib with azacitidine data at ASH
Onconova Therapeutics announced the presentation of the efficacy and safety results of oral rigosertib in combination with azacitidine in patients with HR-MDS reported at an oral presentation during the American Society of Hematology, or ASH. Rigosertib, the company's lead compound, is being evaluated in both intravenous and oral forms. Seventy-four patients were treated with a median age of 69 years at nine clinical sites and received either 840 mg or 1,120 mg of oral rigosertib daily divided into two doses, in combination with a standard dose of injectable azacitidine. Of the 55 evaluable patients, 29 patients were treated with a daily dose of 1,120 mg of oral rigosertib, either 560 mg twice daily or 840 mg in the a.m. and 280 mg in the afternoon. Twenty-six patients were treated with 560 mg in the AM and 280 mg in the PM for the first three weeks of a four-week cycle. All patients also received 75 mg/m2/day SC or IV azacitidine during the second week of the four-week cycle. The median duration of treatment for the HMA naive and HMA failed patients was 7.8 and 4.9 months respectively. The median duration of response in these groups was 12.2 and 10.8 months, respectively. The overall response rate, or ORR, using the IWG 2006 criteria, in 29 HMA naive patients was 90%, including 10 patients with complete remission, or CR. Among the 26 evaluable HMA-failed patients the ORR was 54% including 8% CR or PR. The median time to initial and best response were 1 and 4 cycles in the HMA naive group and 2 and 5 cycles in the HMA failed group. The safety population received at least 1 dose of oral rigosertib. The combination was well tolerated. Other than genitourinary adverse events, or AEs, the AE profile was similar to those described for azacitidine alone in this patient population. Genitourinary AEs, including hematuria and dysuria were observed. A safety optimization strategy was implemented for the higher dose cohort of 1,120 mg of oral rigosertib. These strategies included earlier in the day administration of the PM dose, oral hydration, monitoring of urinary pH and mandatory bladder emptying at night. Collectively these strategies resulted in mitigation of the target genitourinary AEs, including reduction of genitourinary grade 3 AEs reported from an earlier cohort despite receiving a higher dose of oral rigosertib. In conclusion, oral rigosertib in combination with azacitidine was well tolerated in HMA naive and HMA failed HR-MDS patients. The combination produced an encouraging rate of overall response and complete remission in both groups. The safety optimization strategies and increased dose exploration of oral rigosertib in the combination is leading to the development of a pivotal Phase 3 trial in HMA and chemotherapy naive patients. Onconova plans to meet with the FDA to discuss the results of the Phase 2 trial and the planned Phase 3 trial, and to seek a special protocol assessment. The company has partnered rigosertib with SymBio Pharmaceuticals, for Japan and Korea, and with Pint Pharma for Latin American countries. Both partners have indicated their interest in participating in the proposed new pivotal Phase 3 trial by enrolling patients in their respective territories. SymBio is currently conducting Phase 1 studies with oral rigosertib in Japan and also participating in the Phase 3 global INSPIRE trial. The company is also actively seeking additional collaborations for rigosertib in other geographies.

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