Download IND_Minutesdraft_27.02.1

Minutes of IND Committee Meeting Held on
27.02.2012
Item No.1: Phase II clinical trial with BLX-1002.
The committee expressed serious concern on the experimental data and
advised that following information should be submitted by the firm for review of
the committee:
1. It was observed that increase of dose from 30mg/kg to 100mg/kg result in
reverse effects, i.e, higher dose shows less effects as compared to lower
dose. It needs to be clarified.
2. Reason with justification to increase dose from 30mg/kg to 100mg/kg.
3. Earlier doses of the drug used in MAD study were 200mg, 600mg OD
whereas the proposed dose in the study is 250mg BD. Pharmacokinetic data
for 250mg BD in other countries is required to be submitted.
4. Firm informed that there are 14-30% population of NAFLD. The experts
raised concern over this figure and advised the firm to correct it.
5. Investigator’s CVs, duly signed Undertakings of Investigators, CRF, PI sheet
and ICF.
6. In Phase-Ia oral solution and in Phase-II, capsule dosage forms were used.
It needs to be clarified. Dosage form in all the phases of the trial needs to be
provided.
7. Clinical study reports of trials conducted earlier needs to be submitted as per
Schedule-Y.
Detailed preclinical, clinical data, PK data alongwith clarification/information on
above points should be placed before the committee for review.
Item No.2: Phase I/II clinical trial with Rabimabs.
After detailed deliberation the committee recommended for approval of the
proposed study subject to the following conditions:
1. Name of the rabies vaccine to be used in the study should be mentioned in
the protocol.
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2. Investigator undertaking alongwith curriculum vitae duly signed needs to be
submitted.
Revised protocol incorporating the above mentioned changes should be
submitted to the Office of DCG(I) before initiation of the study.
Item No. 3: Phase I clinical trial with ZYT1.
After detailed deliberation the committee recommended that the firm may be
granted permission to conduct the proposed study subject to the following
conditions:
1. Significant increase in total cholesterol, LDL was observed. Patient should
be monitored carefully.
2. Justification for significant increase in testosterone levels in placebo group is
to be submitted.
3. Strict monitoring of thyroid function, liver function, testosterone levels and
sperm count should be done in further studies.
Revised protocol incorporating the above mentioned changes should be
submitted to the Office of DCG(I) before initiation of the study.
Item No. 4. Phase I clinical trials with S0597.
After detailed deliberation the committee recommended to grant permission
subject to the following conditions:
1. Small thymus & pituitary cyst was observed in single animal in gross
pathological data. Accordingly, the firm is required to monitor the patients
carefully.
2. There were 23 AEs with 800mcg dose, 5 AEs with 1600mcg and 8 AEs
with 3200mcg dose. More AEs were observed for lower dose and less
AEs were observed for higher dose which needs to be clarified.
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3. MHED is 0.38 based on toxicity data. The study should be started with
0.35mg dose and other doses should be multiples of 0.35mg.
Revised protocol incorporating the above mentioned changes should be
submitted to the Office of DCG(I) before initiation of the study.
Item No. 5. Phase III clinical trial with Genopep.
After detailed deliberation the committee recommended for approval of the
study subject to the following conditions:
Details of dose and brand of silver sulfadiazine to be used in the study is to
be specified in the protocol.
Revised protocol incorporating the above mentioned change should be
submitted to the Office of DCG(I) before initiation of the study.
Item No.6: Phase II clinical trial of with NRC-AN-019.
After detailed deliberation the committee recommended for the grant of the
permission to conduct the Phase II clinical trial with the drug subject to the
following conditions:
1. Patients with HIV, HBsAg and HCV should be excluded. It should be
specified in exclusion criteria.
2. In the inclusion criteria minimum life expectancy > 6 months should be
mentioned.
3. Molecular response may be included in the objective of the CML study.
4. Patients should be followed for at least 1 month after stopping the treatment.
5. The names of central laboratories may be provided.
6. The sponsor’s declaration should be signed and submitted to DCGI.
7. Post trial access to medicine may be mentioned in case the investigator
feels that it is necessary for the patient keeping in mind the safety profile of
the drug.
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8. Name of the safety physician to be contacted in the case of any emergency
may be mentioned in the protocol and in the informed consent form per
centerwise.
9. CV of all the investigator’s may be appended with the protocol.
Revised protocol etc. as above should be submitted to the Office of DCG(I)
before initiation of the study.
Item No.7: Phase I clinical trial of with P7435.
After detailed deliberation the committee recommended for the grant of the
permission to conduct Phase I clinical trial with the drug subject to the following
conditions:
1. The study should be conducted only on male subjects. The enrolment of
female subjects should be deferred till data from male subjects is generated.
2. The study should be started with the dose of 10mg and then 30mg, 100mg,
300mg & 100mg should be used.
3. There should be 7 days washout period between fasting and fed study.
Item No.8: Proposal to manufacture & market 2-Deoxy-D-Glucose.
After detailed deliberation the committee recommended that the pooled data of
Phase II & Phase III trials with historical comparison with current standard
therapy needs to be analysed and submitted to the committee for further
evaluation.
Item No.9: Phase III clinical trial with VRP1620.
After detailed deliberation the committee recommended that the following
clarification should be submitted by the firm:
1. Plasma concentration is mentioned in mcg/kg. It should be mentioned in
terms of mcg/ml. Necessary clarification should be submitted.
2. QTc is more than 450 (in 5 patients) which needs clarification.
3. The firm has to adjust the dose with respect to 55kg body weight.
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The firm is again advised to re-analyse the data and submit the same to IND
committee alongwith the raw data for evaluation.
Item No.10: Phase I/II clinical trial with live oral cholera vaccine VA 1.4.
After detailed deliberation the committee advised that the applicant should
submit detailed toxicity data. A sub-committee will be constituted to examine the
data and give recommendations.
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